Browse Trials

➤

Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

Use the search box and filters to find a trial that’s right for you.

Currently viewing trials
(Last updated: April 22, 2026)

and or

Reset

Zip Code:

Narrow my choices:

Radius (miles): All U.S.

All U.S.

Early stage

Advanced

Treatment

Non-treatment

Phase I II III

Display Only New Trials

AKT

ALK

BARD1

BRCA1/2 (tumor)

BRIP1

CD205

CD70

CHEK2 or CHEK1

dMMR/MSI-H

ESR1

FGFR

HER2/ERBB2

HLA

MET or C-Met

NTRK

PALB2

PIK3CA or PI3K

PTEN

RAD51

RAF (including BRAF)

RAS (KRAS or NRAS)

ROS1

TP53

Click here to view online studies and trials that do not require site visits

NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA

VISITS: Monthly

PHASE: III

NCT ID: NCT06982521

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced PIK3CA-Mutant HR+, HER2- Breast Cancer

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Tr...(ReDiscover-2) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of RLY-2608 PI3Kα inhibitor plus fulvestrant (Faslodex®) hormone therapy versus capivasertib (Truqap®) AKT inhibitor plus fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation whose cancer has progressed while receiving 1 or 2 lines of hormone therapy and a CDK4/6 inhibitor. You must not have received certain treatments that are listed below. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, daily, 4 days on 3 days off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®) is used to treat HR+, HER2- advanced breast cancer with a mutation in PIK3CA, AKT1, or PTEN.</li> <li class="seamTextUnorderedListItem">RLY-2608 is an experimental treatment being tested to treat HR+, HER2- advanced breast cancer with a mutation in PIK3CA.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">To be eligible for this trial, you must not have received any of the following treatments: alpelisib (Piqray®), capivasertib (Truqap®), pembrolizumab (Keytruda®), dostarlimab-gxly (Jemperli®), fam-trastuzumab deruxtecan-nxki (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; Datroway®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06982521' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://relaytx.com/pipeline/#hero-scroll' target='_blank'>Relay Therapeutics: RLY-2608</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05563220

Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer

A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy in combination with other anti-cancer therapies.

Who is this for?

People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not received treatment with chemotherapy or elacestrant (Orserdu®) for advanced/metastatic disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 4 groups based on your situation: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Physician's choice of palbociclib (Ibrance®), abemaciclib (Verzenio®), or ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05563220' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05879926

Hormone Therapy and Ovarian Suppression With or Without Chemotherapy for Premenopausal Women with Stage I-III HR+, HER2- Breast Cancer

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25 (OFSET) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of adding chemotherapy to treatment with aromatase inhibitor and ovarian function suppression.

Who is this for?

Premenopausal women 18-60 years old with stage I, stage II, or some stage III hormone receptor positive or low (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have received surgery and have an Oncotype DX score of less than 26. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, 5 years</li> <li class="seamTextUnorderedListItem">Ovarian function suppression, every 1-3 months, 5 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, 5 years</li> <li class="seamTextUnorderedListItem">Ovarian function suppression, every 1-3 months, 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that block some production of estrogen that helps cancer grow. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Ovarian suppression can stop the ovaries from making estrogen, putting you into temporary menopause. This prevents the tumor from receiving estrogen it needs to grow.</li> <li class="seamTextUnorderedListItem">The Oncotype DX test can help determine the chance of the cancer coming back and whether a person will benefit from chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05879926' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/ovarian-suppression/' target='_blank'>Susan G. Komen: Ovarian Suppression</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/oncotype-dx' target='_blank'>Breastcancer.org: Oncotype DX</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: 4 visits in 1 month, then 1 visit every month

PHASE: II

NCT ID: NCT06369285

Alisertib Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 2 Study of Alisertib in Combination with Endocrine Therapy in Patients with HR+, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1) Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of alisertib, an experimental AURKA inhibitor, with standard of care hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received at least two hormone therapies including a CDK4/6 inhibitor with hormone therapy for advanced disease. You must not have received chemotherapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib is an experimental targeted therapy called an Aurora Kinase A (AURKA) inhibitor. Blocking AURKA may slow or stop cancer cells from growing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06369285' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pumabiotechnology.com/clinical-trials/alisca_breast1.html' target='_blank'>Puma Biotechnology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/the-role-of-mtor-aurora-a-kinase-combination-therapy-requires-further-elucidation-in-solid-tumors' target='_blank'>OncLive: Alisertib for Advanced Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/alisertib' target='_blank'>National Cancer Institute: Alisertib</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA

VISITS: 1 visit every week for 3-6 months

PHASE: II

NCT ID: NCT01042379

I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.

Who is this for?

People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups and receive the following before surgery: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco Health
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05508906

OP-1250 Hormone Therapy with Targeted Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of OP-1250, an experimental hormone therapy, with ribociclib (Kisqali®) CDK 4/6 inhibitor or alpelisib (Piqray®) PI3K inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1-2 hormone therapies for advanced or metastatic disease. You must not have received more than 1 chemotherapy for advanced or metastatic disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250 is an experimental hormone therapy called a selective estrogen receptor downregulator (SERD) and complete estrogen receptor antagonist (CERAN). SERDs bind to and break down estrogen receptors, and CERANs block estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05508906' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/science/' target='_blank'>Olema Oncology Drug Information Page: OP-1250</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF
San Francisco,CA

VISITS: At least 1 visit every 6 months for 5 years

PHASE: II

NCT ID: NCT06075953

DCIS RECAST: Hormone Therapy and Active Surveillance for Women with HR+ DCIS

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study Scientific Title

Purpose

To study if hormone therapy and active monitoring (MRIs and mammograms) is an effective way to treat and manage DCIS.

Who is this for?

Women with stage 0 (DCIS) hormone receptor positive (ER+ and/or PR+) breast cancer who have not yet received surgery. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: Group 1 (if surgery is needed): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy (standard of care or experimental) for 6 months</li> <li class="seamTextUnorderedListItem">MRI scans, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Saliva sample for genetic testing</li> <li class="seamTextUnorderedListItem">Followed by surgery</li> </ul> Group 2 (if surgery is not needed): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy (standard of care or experimental) for 6 months</li> <li class="seamTextUnorderedListItem">MRI scans, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Saliva sample for genetic testing</li> </ul> Followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy, continue for 2-5 years</li> <li class="seamTextUnorderedListItem">MRI scan or mammogram, alternating every 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">After evaluation at 6 months, participants will either have surgery (if recommended) or continue on the treatment for 2-5 years.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">(Z)-endoxifen is similar to tamoxifen.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs work by blocking the activity of estrogen in people with mutations in the ESR1 gene.</li> <li class="seamTextUnorderedListItem">Testosterone is a hormone that may reduce the risk of breast cancer.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A mammogram is a breast cancer screening procedure involving taking an x-ray picture of the breast.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06075953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quantumleaphealth.org/for-patients/i-spy-recast-dcis-patient/' target='_blank'>Quantum Leap Healthcare Collaborative: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/ductal-carcinoma-in-situ' target='_blank'>Breastcancer.org: DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (Data collection only)
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06099769

Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or ER Low, Androgen Receptor Positive Breast Cancer

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of enzalutamide (Xtandi®), an experimental hormone therapy, alone or with mifepristone, an experimental hormone therapy, compared to standard of care chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2-) or ER low, androgen receptor positive (AR+) breast cancer who have received 0-1 lines of chemotherapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> </ul> Group 3: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is an anti-androgen hormone therapy approved for people with prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Mifepristone is an anti-progesterone hormone therapy. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), paclitaxel (Taxol®), capecitabine (Xeloda®), and eribulin (Halaven®) are standard of care chemotherapy medications used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">If you are in group 3, you may be able to switch to group 2 if your cancer progresses.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06099769' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>Medline Plus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05768139

STX-478 Targeted Therapy for Advanced HR+, HER2- Breast Cancer with a PI3K Mutation

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of STX-478, an experimental PI3K inhibitor, alone or with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PI3K mutation. You must not have a PTEN, AKT, or mTOR mutation. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478 is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PI3K</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05768139' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.scorpiontx.com/pipeline/' target='_blank'>Scorpion Therapeutics: STX-478 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 3 miles
Research Site
San Francisco,CA

VISITS: 1 visit per month, ongoing

PHASE: III

NCT ID: NCT04862663

Capivasertib, Palbociclib, and Fulvestrant for Advanced ER+, HER2- Breast Cancer

A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer Scientific Title

Purpose

To study the dose, safety, side effects, and anti-cancer activity of giving the targeted therapies capivasertib and palbociclib (Ibrance®) with the anti-estrogen therapy fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer. Your cancer must have progressed on anti-estrogen therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, daily (4 days on, 3 days off), ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy that blocks the Akt protein. The Akt protein helps cancer cells divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. It is approved for treating metastatic hormone-positive, HER2-negative breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04862663' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/capivasertib?redirect=true' target='_blank'>NCI Drug Dictionary: Capivasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30857-5/fulltext' target='_blank'>Journal Article: Capivasertib Inhibits a Key Pathway in Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615013.html' target='_blank'>Medline Plus: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Fulvestrant' target='_blank'>Wikipedia: Fulvestrant</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco (UCSF)
San Francisco,CA

VISITS: At least 1-2 visits every year for 5 years

PHASE: III

NCT ID: NCT06492616

Elacestrant Compared to Standard of Care Hormone Therapy for People with Stage I-III ER+, HER2-, Node Positive Breast Cancer

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of elacestrant hormone therapy compared to standard of care hormone therapy.

Who is this for?

People with stage I, stage II, or some stage III estrogen receptor positive (ER+), HER2 negative (HER2- or HER2 low), node positive breast cancer who have received surgery and have a high risk of recurrence. You must be currently receiving hormone therapy for at least 2 years but no more than 5 years. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily for 5 years</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care hormone therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Node positive means cancer has spread to your lymph nodes.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06492616' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center-Mission Bay
San Francisco,CA

VISITS: Please contact research site

PHASE: II

NCT ID: NCT05564377

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH) Scientific Title

Purpose

To use genetic testing to match people to treatments and help doctors plan better treatments.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04852887

Hormone Therapy Alone or With Radiation for Stage I HR+, HER2- Breast Cancer

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) and anti-cancer activity of hormone therapy alone or with radiation after a lumpectomy.

Who is this for?

People with stage I hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received a lumpectomy within the past 3 months. You must not have received chemotherapy or radiation. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Hormone Therapy and Radiation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®), daily, at least 5 years</li> <li class="seamTextUnorderedListItem">Radiation</li> </ul> Group 2: Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®), daily, at least 5 years</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04852887' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nrgoncology.org/Home/News/Post/NRG-BR007-The-DEBRA-Trial' target='_blank'>NRG Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family CCC
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT07100106

GDC-4198 CDK2/4/6 Inhibitor Plus Giredestrant Oral SERD Versus Abemaciclib Plus Giredestrant for Advanced ER+, HER2- Breast Cancer

A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination With Giredestrant in Comparison With Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progre... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of GDC-4198 CDK2/4/6 inhibitor and giredestrant oral SERD compared with abemaciclib (Verzenio®) CDK4/6 inhibitor and giredestrant.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have experienced disease progression during or after receiving a CDK4/6 inhibitor and hormone therapy. You must not have received more than 1 line of therapy or chemotherapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-4198, by mouth, daily, up to 3 years</li> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, up to 3 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, up to 3 years</li> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, up to 3 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-4198 is an experimental CDK2/4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07100106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://regor.com/#pipeline' target='_blank'>Regor Therapeutics: GDC-4198</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/giredestrant' target='_blank'>Genentech: Giredestrant</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06638307

MEN2312 Targeted Therapy Alone or with Hormone Therapy for Advanced HR+ Breast Cancer

A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of MEN2312, an experimental KAT6 inhibitor, alone or with elacestrant (Orserdu®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. You must have received no more than 6 lines of therapy for advanced disease, including no more than 2 lines of chemotherapy and/or antibody drug conjugates (ADC). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN2312, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN2312, by mouth</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN2312 is an experimental targeted therapy called a KAT6 inhibitor. Blocking KAT6 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06638307' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://stemline.com/product-pipeline/' target='_blank'>Stemline Therapeutics: MEN2312 Drug Information Page</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04606446

Experimental Therapy PF-07248144 for Advanced ER+, HER2- Breast Cancer

A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic Solid Tumors. Scientific Title

Purpose

To study the safety, side effects, dose, and anti-cancer activity of giving PF-07248144 alone, in combination with fulvestrant, or with palbociclib and letrozole.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed after receiving a CDK 4/6 inhibitor and anti-estrogen therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144 is a KAT6 Inhibitor</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04606446' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04606446' target='_blank'>Pfizer Trial Information Page: PF-07248144</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/update-on-hormone-receptor-positive-mbc-2021/' target='_blank'>Metastatic Trial Talk: Update on Hormone Receptor-Positive MBC</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: At least 1 visit every month

PHASE: I-II

NCT ID: NCT06993844

ETX-636 Targeted Therapy for Advanced HR+, HER2- Breast Cancer With PIK3CA Mutations

A Phase 1/2, Open-label, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ETX-636, a Pan-mutant-selective PI3Kα Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ETX-636, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with PIK3CA mutations who have received at least 1 CDK4/6 inhibitor and hormone therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-636, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ETX-636 is an experimental targeted therapy called a PI3K alpha inhibitor that blocks the growth of cancer cells with a PIK3CA mutation.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06993844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ensemtx.com/science/pipeline/' target='_blank'>Ensem Therapeutics: ETX-636 Drug Information Page</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: About 2 times every month for 2 months, then about every month

PHASE: III

NCT ID: NCT06760637

PF-07220060 CDK4 Inhibitor with Hormone Therapy for Newly Diagnosed Advanced HR+, HER2- Breast Cancer

AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTA... (FourLight-3) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PF-07220060, an experimental CDK4 inhibitor, with letrozole (Femara®) hormone therapy compared to standard of care treatment.

Who is this for?

People with newly diagnosed advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received treatment for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a CDK4 inhibitor. CDK4 is a protein that helps cancer grow. Blocking CDK4 helps slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are types of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06760637' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct06760637-metastatic-breast-cancer-trial?cmp=0db2aa16-cafd-419f-9d33-b4b4540f6dcf&ttype=BA' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/novel-cdk4-inhibitor-shows-activity-and-safety-in-hr-her2-metastatic-breast-cancer' target='_blank'>OncLive: PF-07220060 for Metastatic HR+, HER2- Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco (UCSF)
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04802759

Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER) Scientific Title

Purpose

To study the anti-cancer activity and safety of giving the experimental anti-estrogen therapy giredestrant alone or with a CDK 4/6 inhibitor, an AKT inhibitor, a PI3K inhibitor, or chemotherapy.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor and who have not received chemotherapy for metastatic disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Faslodex is given by injection. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is also a CDK 4/6 inhibitor. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an experimental type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT. </li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental type of targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Inavolisib may slow or stop cancer cells from growing by blocking this pathway. </li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04802759' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant (GDC-9545)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors (Abemaciclib & Ribociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib (AKT Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/everolimus.aspx' target='_blank'>Chemocare: Everolimus (Afinitor)</a> </li></ul>

NEAREST SITE: 14 miles
Palo Alto Medical Foundation Research Center
San Mateo,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06790693

Inavolisib Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for HR+, HER2- Advanced Breast Cancer with PIK3CA Mutations

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4/6 Inhibitor and Letrozole Versus Placebo Plus a CDK4/6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with palbociclib (Ibrance®) CDK4/6 inhibitor and letrozole (Femara®) aromatase inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation. You must have been diagnosed with de novo advanced/metastatic breast cancer or received at least 2 years of hormone therapy and completed hormone therapy at least 1 year before your advanced/metastatic diagnosis. You must have not yet received treatment for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib (Itovebi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®) is a type of targeted therapy called a PI3K inhibitor. It can stop cancer cell growth of tumors with a PIK3CA mutation.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06790693' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.itovebi.com/?c=ina-192c045e973&gad_source=1&gad_campaignid=22379686314&gclid=CjwKCAjw3_PCBhA2EiwAkH_j4vPWHwf18zpyVOBvHcRP6iHfngpGw_isqNXvAvPlr2i6vJ0TAA8mdxoCtHYQAvD_BwE&gclsrc=aw.ds' target='_blank'>Hoffman-La Roche: Inavolisib (Itovebi®)</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care Inc
Greenbrae,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06065748

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, compared with fulvestrant (Faslodex®) hormone therapy in combination with a CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who not have received treatment (except for surgery or radiation) for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and giredestrant are a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental SERD.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">The FoundationOne Liquid CDx Assay blood test will identify ctDNA mutations.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06065748' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html#:~:text=This%20compound%20and%20its%20use,US%20Food%20and%20Drug%20Administration.' target='_blank'>Genentech: Giredestrant Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care
Greenbrae,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06997029

BMS-986500 CDK4/6 Inhibitor for Advanced HR+ Breast Cancer

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of BMS-986500, a CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986500</li> <li class="seamTextUnorderedListItem">Palbociblib (Ibrance®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986500 is a CDK4/6 inhibitor. </li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06997029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care
Greenbrae,CA

VISITS: Every 2 weeks for 2 months; then monthly visits thereafter

PHASE: III

NCT ID: NCT07174336

Tersolisib PI3Ka Inhibitor For HR+, HER2- or HER2 Low Advanced Breast Cancer with a PIK3CA Mutation

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2) Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of Tersolisib (LY4064809), an experimental PI3Ka inhibitor, with standard of care CDK4/6 inhibitor and hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer with a PIK3CA mutation. You may have received 0-2 prior treatments for advanced or metastatic breast cancer. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: Part 1: For people who have received prior treatment: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809), by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li> </ul> Part 2: For people who have not yet received treatment, you will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809), by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809) is an experimental type of targeted therapy called a PI3K inhibitor. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Tersolisib may slow or stop cancer cells from growing by blocking this pathway.</li> <li class="seamTextUnorderedListItem">Standard of care treatment for hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer is treatment with hormone therapy along with a CDK inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07174336' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-biomarkers-part-1/' target='_blank'>Metastatic Trial Talk: Biomarkers to Guide MBC Treatment Decisions: PIK3CA, BRCA1/BRCA2, and PD-L1/PD-1</a> </li></ul>

NEAREST SITE: 23 miles
Research Site
Walnut Creek,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05952557

Camizestrant Hormone Therapy for Stage I-III ER+, HER2- Breast Cancer

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of camizestrant, an experimental hormone therapy, compared to standard of care hormone therapy.

Who is this for?

People with stage I, stage II, or some stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received surgery less than 1 year ago and have completed standard treatment. You must not have received fulvestrant (Faslodex®). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy: Exemestane (Aromasin®), letrozole (Femara®), anastrozole (Arimidex®), or tamoxifen (Nolvadex®)</li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth </li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05952557' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.goodrx.com/conditions/breast-cancer/oral-serd' target='_blank'>GoodRX: What is a SERD?</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University Medical Center
Stanford,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07114601

LY4257496 GRPR Radiopharmaceutical for Advanced ER+ Breast Cancer

A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of LY4257496 GRPR radiopharmaceutical with or without standard of care therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) breast cancer. Your tumor must be positive for gastrin-releasing peptide receptor (GRPR). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4257496, by IV, up to 9 months</li> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4257496, by IV, up to 9 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4257496 is a radiopharmaceutical that targets GRPR. A radiopharmaceutical is a type of therapy that combines a molecule that targets cancer cells with a radioactive molecule that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Gastrin Releasing Peptide Receptor (GRPR) is a G protein coupled receptor activated by the peptide gastrin-releasing peptide (GRP), which regulates various bodily functions, including gastrointestinal activity and central nervous system processes. GRPR plays a role in normal functions like hormone release and smooth muscle contraction.</li> <li class="seamTextUnorderedListItem">Standard of care options in this trial are fulvestrant (Faslodex®), imlunestrant (Inluriyo®), capecitabine (Xeloda®), abemaciclib (Verzenio®) and aromatase inhibitors- letrozole (Femara®), anastrozole (Arimidex®), and exemestane (Aromasin®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07114601' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/mbc-radiopharmaceuticals/' target='_blank'>Metastatic Trial Talk: Radiopharmaceuticals</a> </li></ul>

NEAREST SITE: 32 miles
Palo Alto Medical Foundation
Mountain View,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05827081

Ribociclib CDK4/6 Inhibitor with Hormone Therapy for Stage II-III HR+, HER2- Breast Cancer

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER) Scientific Title

Purpose

To study if ribociclib (Kisqali®) CDK4/6 inhibitor with hormone therapy increases the amount of time before breast cancer comes back.

Who is this for?

People with some stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose surgical margins do not have cancer. You must have begun hormone therapy in the last 3 years and be planning to receive hormone therapy for at least 3 more years. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off, for 3 years</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are postmenopausal, hormone therapy consists of letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">If you are premenopausal or male, hormone therapy consists of letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®) plus goserelin (Zoladex®) or leuprolide (Lupron Depot®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05827081' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 53 miles
Providence Medical Foundation - Santa Rosa, CA
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05696626

Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation

An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lasofoxifene, an experimental hormone therapy, with abemaciclib (Verzenio®) CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received an aromatase inhibitor with palbociclib (Ibrance®) or ribociclib (Kisqali®) CDK4/6 inhibitor as your first line of hormone therapy for advanced disease. You must not have received more than 1 line of chemotherapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05696626' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://sermonixpharma.com/lasofoxifene/' target='_blank'>Sermonix Pharmaceuticals: Lasofoxifene Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 186 miles
Renown Regional Medical Center ( Site 0018)
Reno,NV

VISITS: About 1 visit every month

PHASE: II

NCT ID: NCT06428396

Belzutifan Targeted Therapy with Hormone Therapy for Advanced ER+, HER2- Breast Cancer

A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (MK-6482-029/LITESPARK-029) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of belzutifan (MK-6482), an experimental targeted therapy, with hormone therapy compared to standard of care targeted therapy and hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received at least 1 line of hormone therapy for advanced disease. You must not have received chemotherapy or a PARP inhibitor for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental Targeted Therapy with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> Group 2: Targeted Therapy with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly or exemestane (Aromasin®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482) is an experimental targeted therapy called a HIF-2a inhibitor. Blocking HIF-2a may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Belzutifan (MK-6482) is approved for use in other cancers. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06428396' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20240821/belzutifan-improves-pfs-response-in-advanced-renal-cell-carcinoma' target='_blank'>Healio: Belzutifan for Advanced Kidney Cancer</a> </li></ul>

NEAREST SITE: 186 miles
Renown Regional Medical Center
Reno,NV

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05216432

RLY-2608 Alone and With Fulvestrant for Advanced Breast Cancer with a PIK3CA Mutation

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of RLY-2608 alone and in combination with fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require a biopsy</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608 is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">RLY-2608 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05216432' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-dosing-first-patient-first-human-0' target='_blank'>Relay Therapeutics Press Release: RLY-2608</a> </li></ul>

NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT04553770

Trastuzumab Deruxtecan Alone or With Hormone Therapy for Stage II-III HER2 Low, HR Positive Breast Cancer

A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting Scientific Title

Purpose

To study and compare the anti-cancer acitivity and safety of giving trastuzumab deruxtecan-nxki (Enhertu®) alone or with the anti-estrogen therapy anastrozole (Arimidex®) before surgery (neoadjuvant).

Who is this for?

People with stage II or stage III hormone positive (ER+ and/or PR+), HER2 low expression (defined below) breast cancer whose tumor is 2 cm or larger and who have not yet started treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups and recieve the following before surgery: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, for 4.5 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a chemotherapy directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early stage and metastatic hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04553770' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab_deruxtecan' target='_blank'>Wikipedia: Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020%3bs%3bph%3bbr%3bonc%3bhcp%3bbr&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqia48j9brc-arisamqu3wqel0xz_rkoi7g8nk-ckknd1pfqh_i4wknawmwg' target='_blank'>Daiichi-Sankyo Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing, A New Subcategory of HER2 Negative Breast Cancer?</a> </li></ul>

NEAREST SITE: 336 miles
University of California LA
Los Angeles,CA

VISITS: At least 1 visit every month

PHASE: I-II

NCT ID: NCT06726148

ECI830 CDK2 Inhibitor with CDK4/6 Inhibitor and Hormone Therapy for Advanced HR+, HER2- Breast Cancer

An Open-label, Multi-center, Phase I/II Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of ECI830, an experimental; CDK2 inhibitor, with ribociclib (Kisqali®) CDK4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor or tamoxifen (Nolvadex®) with a CDK4/6 inhibitor. You must not have received more than 2 lines of hormone therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> Group 3: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block an enzyme, CDK2, that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®). are letrozole (Femara®), anastrozole (Arimidex®), and exemestane (Aromasin®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06726148' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/nct06726148' target='_blank'>Novartis: Trial Information Page</a> </li></ul>

NEAREST SITE: 336 miles
University of California, Los Angeles (UCLA)
Los Angeles,CA

VISITS: At least 1 visit every month

PHASE: I-II

NCT ID: NCT04115306

PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ Breast Cancer

Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of PMD-026, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), RSK2 positive (RSK2+) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental targeted therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04115306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://phoenixmd.ca/pipeline' target='_blank'>Drug Company Information Page: PMD-026</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29498411' target='_blank'>PubMed Abstract: RSK1 Promotes Murine Breast Cancer Growth and Metastasis</a> </li></ul>

NEAREST SITE: 336 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06380751

Saruparib PARP1 Inhibitor with Camizestrant Hormone Therapy for Advanced HR+, HER2- or HER2 Low Breast Cancer with BRCA1, BRCA2, or PALB2 Mutations

EvoPAR-BR01: A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Br... Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of saruparib, an experimental PARP1 inhibitor, with camizestrant, an experimental hormone therapy, to standard of care CDK4/6 inhibitor with hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer with BRCA1, BRCA2, or PALB2 mutations. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 3 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305), by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth</li> </ul> Group 3: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305) is an experimental targeted therapy called a PARP1 inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06380751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D9722C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/next-generation-parp-inhibitor-demonstrates-clinical-benefit-in-patients-with-homologous-recombination-repair-deficient-breast-cancer/' target='_blank'>AACR: Saruparib for Homologous Recombination Repair Deficient Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>AACR: Camizestrant for Hormone Receptor Positive, HER2 Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 336 miles
UCLA Jonsson Comp Cancer Center
Los Angeles,CA

VISITS: 5 visits in 1 month, then 1-2 visits every month

PHASE: I

NCT ID: NCT05870579

177Lu-Lu-NeoB Radioactive Drug with Ribociclib and Fulvestrant for Advanced ER+, HER2- or HER2 Low, GRPR+ Breast Cancer

A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocr... Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with ribociclib (Kisqali®) targeted therapy and fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low, gastrin releasing peptide receptor (GRPR) positive (GRPR+) breast cancer who have received no more than 1 line of therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB, by IV, monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">PET scans with 68Ga-Ga-NeoB, by IV, 2-3 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The experimental tracer in this study is 68Ga-Ga-NeoB.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug every month that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05870579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/NCT05870579' target='_blank'>Novartis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/diagnostic-services/radiology-diagnostic-imaging-and-interventional-radiology/services-and-locations/radiopharmaceuticals/#:~:text=Radiopharmaceuticals%20are%20a%20unique%20class,linker%20that%20joins%20the%20two.' target='_blank'>Moffitt Cancer Center: Radiopharmaceuticals</a> </li></ul>

NEAREST SITE: 336 miles
Avenzo Therapeutics Recruiting Site
Los Angeles,CA

VISITS: Number of visits unavailable, up to 2 years

PHASE: I-II

NCT ID: NCT06998407

AVZO-023 Plus Hormone Therapy and an Experimental CDK2 Inhibitor for Advanced HR+, HER2- Breast Cancer

A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of AVZO-023 CDK4 inhibitor in combination with hormone therapy and an experimental CDK2 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must not have received CDK2, 4, and/or 6 inhibitors. You must not have active, untreated brain metastases. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">AVZO-021, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">AVZO-021, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).</li> <li class="seamTextUnorderedListItem">AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK2). CDK inhibitors block enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06998407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/#moa' target='_blank'>Avenzo Therapeutics: AVZO-023</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 339 miles
START Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT07287917

AMXT 1501 and DFMO in Combination With Standard Therapies for Advanced ER+, HER2- Breast Cancer

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of AMXT 1501 and DFMO when combined with standard treatments.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with alterations in the genes, PIK3CA, AKT1, or PTEN, whose cancer has progressed on at least 2 hormone therapies. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMXT 1501, by mouth, daily</li> <li class="seamTextUnorderedListItem">DFMO, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, 4 days on, 3 days off</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsies, 2 times within 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AMXT 1501 and DFMO block molecules involved in tumor growth and survival. Together, they may improve tumor response to standard cancer treatments, reduce tumor growth, and reverse tumor-induced immunosuppression.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®) is a targeted therapy for people with abnormal changes in PIK3CA, AKT1, and/or PTEN genes and whose cancer has progressed on or after hormone therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with melanoma (skin cancer).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07287917' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://aminextx.com/science/' target='_blank'>Aminex Therapeutics: AMXT 1501 and DFMO</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Hematology Oncology Santa Monica
Los Angeles,CA

VISITS: 1 visit every 1-2 weeks

PHASE: III

NCT ID: NCT06757634

Gedatolisib Targeted Therapy with CDK4/6 Inhibitor and Hormone Therapy for Advanced HR+, HER2- Breast Cancer

VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental targeted therapy, with standard of care CDK4/6 inhibitor and hormone therapy compared to standard of care alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who were diagnosed with advanced disease during or within 1 year of completing hormone therapy. You must have not yet received treatment for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K/mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are types of targeted therapies called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06757634' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/our-approach/viktoria-2-2/' target='_blank'>Celcuity: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity: Gedatolisib Drug Information Page</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06239467

OKI-219 Targeted Therapy for Advanced HR+ Breast Cancer with PI3K Mutations

PIKture-01: First-in-Human Study of the PI3KÃŽ±H1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer (PIKture-01) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of OKI-219, an experimental PI3Kα inhibitor, with fulvestrant (Faslodex®) hormone therapy or trastuzumab (Herceptin®) anti-HER2 targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 positive (HER2+) breast cancer with a PI3KαH1047R mutation. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1: HR positive, HER2 negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 2: HER2 positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PI3KαH1047R is a common type of PI3KCA mutation.</li> <li class="seamTextUnorderedListItem">OKI-219 is an experimental targeted therapy called a PI3Kα inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow. OKI-219 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy called a selective estrogen receptor degraders (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06239467' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://onkuretherapeutics.com/pipeline/' target='_blank'>OnKure: OKI-219 Drug Information Page</a> </li></ul>

NEAREST SITE: 339 miles
University California, Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05304962

RGT-419B Targeted Therapy for HR+, HER2- Advanced Breast Cancer

First-in-Human, Escalating Oral Dose Study of RGT-419B Given Alone and With Endocrine Therapy in Subjects With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced/Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of RGT-419B, an experimental type of targeted therapy called a CDK 2/4/6 inhibitor, alone and with hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has progressed after treatment with a CDK 4/6 inhibitor and hormone therapy. You must not have received more than 1 line of chemotherapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B is an experimental type of targeted therapy called a CDK 2/4/6 inhibitor. It is designed to block three enzymes, CDK2, CDK4, and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive one of the following types of hormone therapy that you have already received: selective estrogen receptor degrader (SERD), selective estrogen receptor modulator (SERM), or aromatase inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05304962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/regor-therapeutics-announces-u-s-fda-authorization-to-conduct-regor-s-first-in-human-clinical-trial-with-the-next-generation-targeted-inhibitor-rgt-419b-for-oncology/' target='_blank'>Regor Therapeutics Press Release: RGT-419B</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: CDK Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 342 miles
California Research Institute
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05607004

Z-Endoxifen Hormone Therapy for Premenopausal Women With Stage II ER+, HER2- Breast Cancer

A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen and Exemestane + Goserelin as Neoadjuvant Treatment in Premenopausal Women With ER+/HER2- Breast Cancer Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) Z-endoxifen, an experimental hormone therapy, to exemestane (Aromasin®) and goserelin (Zoladex®) hormone therapies.

Who is this for?

Premenopausal women with stage II estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Z-endoxifen, by mouth, daily for 1-7 months</li> </ul> followed by (optional, if low Ki-67 levels after 1 month): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Z-endoxifen, by mouth, daily for 1-7 months</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly for 1-7 months</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), by mouth, daily for 1-7 months</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly for 1-7 months</li> </ul> followed by (optional, if low Ki-67 levels after 1 month): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Z-endoxifen, by mouth, daily for 1-7 months</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly for 1-7 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Z-endoxifen is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) is a type of hormone therapy called an aromatase inhibitor.</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®) is a type of hormone therapy called a LHRH agonist that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors and LHRH agonists block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Your type of treatment and length of treatment will be determined by the Ki-67 levels in your tumor after 1 month of treatment.</li> <li class="seamTextUnorderedListItem">Ki-67 is a cancer marker that indicates how well the treatments work to slow cancer cell growth.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Ki-67</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05607004' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/endoxifen-hydrochloride' target='_blank'>National Cancer Institute: Z-Endoxifen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/zoladex' target='_blank'>Breastcancer.org: Goserelin (Zoladex®)</a> </li></ul>

NEAREST SITE: 342 miles
California Research Institute
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05386108

Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for ER+, HER2- Breast Cancer with Brain Metastasis

An Open-label Multicenter Phase 1b-2 Study of Elacestrant as Monotherapy and in Combination With Abemaciclib in Women and Men With Brain Metastasis From Estrogen Receptor Positive, HER-2 Negative Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant, an experimental hormone therapy, alone or with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?

People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain (brain metastasis) who have received at least 1 hormone therapy, up to 2 chemotherapies, and up to 2 CDK 4/6 inhibitors for metastatic disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®)</li> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05386108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

NEAREST SITE: 342 miles
Clinical Trial Site
Los Angeles,CA

VISITS: Coincides with routine care

PHASE: III

NCT ID: NCT06016738

Palazestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer

A Phase 3 Randomized, Open-Label Study Of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of palazestrant (OP-1250), an experimental hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. You must not have received chemotherapy or more than 2 lines of hormone therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant (OP-1250)</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy: fulvestrant (Faslodex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant (OP-1250) and fulvestrant (Faslodex®) are types of hormone therapy called selective estrogen receptor degraders (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is approved, and palazestrant (OP-1250) is experimental.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06016738' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://opera01study.com/' target='_blank'>Olema Pharmaceuticals: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/pipeline/' target='_blank'>Olema Pharmaceuticals: Palazestrant (OP-1250) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

NEAREST SITE: 346 miles
Los Angeles Cancer Network
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT07368998

Inavolisib With Fulvestrant for Advanced HR+, HER2- Breast Cancer with PIK3CA Mutations

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor. You must not have received more than 1 line of anti-hormone therapy with a CDK 4/6 inhibitors for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To find out how well inavolisib with fulvestrant works, and how safe inavolisib is at different doses. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®) is a type of targeted therapy called a PI3K inhibitor. It can stop cancer cell growth of tumors with a PIK3CA mutation.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07368998' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/health/metastatic-breast-cancer/pik3ca-mutation-and-breast-cancer#what-is-the-pik-3-ca-gene' target='_blank'>Healthline: PIK3CA Mutations in Breast Cancer: What Does It Mean?</a> </li></ul>

NEAREST SITE: 348 miles
USC/Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: 1 visit every 6 months (coincides with standard follow up visits), for up to 7 years

PHASE: II

NCT ID: NCT04567420

A ctDNA Blood Test to Screen for Recurrence for Stage II-III ER+, HER2- Breast Cancer

A Randomized Phase II Trial Of Circulating Tumor DNA-Guided Second Line Adjuvant Therapy For High Residual Risk, Stage II-III, Hormone Receptor Positive, HER2 Negative Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity, safety, and side effects of using a ctDNA blood test to guide treatment decisions in people who are taking anti-hormone therapy after surgery.

Who is this for?

People with stage II or stage III estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer. You must be taking hormone therapy after surgery for at least the last 6 months. Your cancer must be considered at high risk for recurrence (coming back). See below for the definition of high-risk. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA blood test, every 4 to 6 months, for up to 7 years</li> </ul> If a ctDNA blood test is positive, you will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your current anti-hormone therapy (an aromatase inhibitor or tamoxifen)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream. </li> <li class="seamTextUnorderedListItem">Researchers are studying if a test looking for ctDNA in the bloodstream can determine if there will be a recurrence (coming back) of a person's breast cancer. </li> <li class="seamTextUnorderedListItem">The ctDNA blood test used in this trial is called Signatera. </li> <li class="seamTextUnorderedListItem">This trial is also studying if a recurrence can be stopped or delayed by giving people with a positive ctDNA test additional treatment.</li> <li class="seamTextUnorderedListItem">The additional treatment in this trial includes Palbociclib (Ibrance®) and Fulvestrant (Faslodex®).</li> <li class="seamTextUnorderedListItem">Palbociclib is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Fulvestrant is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader). It is approved to treat some people with advanced HR+ breast cancer.</li> <li class="seamTextUnorderedListItem">For this trial, some of the definitions of cancer at high risk of recurrence include: </li> <li class="seamTextUnorderedListItem">Cancer found in 4 or more lymph nodes, or </li> <li class="seamTextUnorderedListItem">A tumor 5 cm or larger, or</li> <li class="seamTextUnorderedListItem">Cancer found in 1 to 3 lymph nodes, and your tumor was at least 3 cm, or grade 3 or, your Oncotype DX score was greater than 26, MammaPrint score was high risk, EndoPredict was greater than 4, or Prosigna score was greater than 60.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04567420' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>What is Circulating Tumor DNA and How is it Used to Diagnose and Manage Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.natera.com/oncology/signatera-advanced-cancer-detection/' target='_blank'>Natera ctDNA Test Information Page: Signature</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2021/a-tale-of-two-cdk46-inhibitors-in-early-breast-cancer/' target='_blank'>The ASCO Post: A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope Comprehensive Cancer Center
Duarte,CA

VISITS: 2-3 visits within 6 months

PHASE: II

NCT ID: NCT05941520

Acolbifene or Low Dose Tamoxifen to Prevent Breast Cancer in Premenopausal Women at High Risk for Breast Cancer

Phase IIA Trial of Acolbifene (20 mg) vs Low Dose Tamoxifen (5 mg) in Pre-Menopausal Women at High Risk for Development of Breast Cancer Scientific Title

Purpose

To compare acolbifene and low dose tamoxifen (Nolvadex®) hormone therapies to prevent breast cancer for postmenopausal women at high risk for breast cancer.

Who is this for?

Premenopausal women at least 35 years old who have a high risk for developing breast cancer. High risk is defined below. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acolbifene, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Mammogram, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Breast biopsy, 2 times</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Low-dose tamoxifen (Nolvadex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Mammogram, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Breast biopsy, 2 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High risk is defined as at least 1 of the following: abnormal biopsy; history of DCIS or LCIS (stage 0 breast cancer); high breast density; family history; and/or an ATM, BARD1, BRIP1, CDH1, CHEK2, MSH6, NBN, NF1, PTEN, PMS2, RAD51C, RAD51D, or TP53 gene mutation. You must not have a BRCA1/2 or PALB2 gene mutation.</li> <li class="seamTextUnorderedListItem">People at high risk for breast cancer may receive breast MRI, ultrasound, mammograms, mastectomy, and/or tamoxifen (Nolvadex®).</li> <li class="seamTextUnorderedListItem">Estrogen can cause the development and growth of breast cancer cells. Acolbifene and tamoxifen (Nolvadex®) hormone therapies block the use of estrogen by breast cells.</li> <li class="seamTextUnorderedListItem">The dose of tamoxifen (Nolvadex®) used in this study is four times lower than the standard dose.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05941520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/types/breast-cancer/risk-and-prevention/tamoxifen-and-raloxifene-for-breast-cancer-prevention.html' target='_blank'>American Cancer Society: Tamoxifen and Raloxifene for Lowering Breast Cancer Risk</a> </li></ul>

NEAREST SITE: 374 miles
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange,CA

VISITS: 2 visits in 1 month, then monthly

PHASE: II

NCT ID: NCT05524584

Hormone Therapy and Targeted Therapy for Advanced HR+, HER2- Breast Cancer

Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) and anastrozole (Arimidex®) hormone therapies with abemaciclib (Verzenio®) CDK 4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that is newly diagnosed or that progressed at least 1 year after finishing standard treatment. You must not have received treatment with fulvestrant (Faslodex®) or a CDK 4/6 inhibitor. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is type of hormone therapy called an aromatase inhibitor. It is commonly used to treat early-stage and metastatic hormone-positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05524584' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

NEAREST SITE: 381 miles
Hoag Memorial Presbyterian
Newport Beach,CA

VISITS: At least 1 visit every month

PHASE: I

NCT ID: NCT06756932

BGB-21447 Targeted Therapy with Hormone Therapy and CDK4 Inhibitor for Advanced HR+, HER2- Breast Cancer

A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of BGB-21447, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy, with or without BGB-43395, an experimental CDK4 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received at least 2 lines of therapy for advanced disease and hormone therapy with a CDK4/6 inhibitor for early stage or advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-21447, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-21447, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-21447 is an experimental targeted therapy called a Bcl-2 Inhibitor. Blocking Bcl-2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">BGB-43395 is an experimental targeted therapy called a CDK4 inhibitor. CDK4 is a type of protein that regulates cell growth and division in your body. Blocking CDK4 is believed to have anti-tumor effects.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06756932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 381 miles
Hoag Memorial Hospital Presbyterian
Newport,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05455619

Evexomostat for Women with Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation and High Blood Sugar

Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of evexomostat (SDX-7320), an experimental polymer drug conjugate, with fulvestrant (Faslodex®) hormone therapy and alpelisib (Piqray®) PI3K inhibitor.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation who have high blood sugar. You must have received hormone therapy and a CDK 4/6 inhibitor. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05455619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amelia1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

NEAREST SITE: 441 miles
University of California, San Diego
La Jolla,CA

VISITS: Monthly for up to 6 months

PHASE: II

NCT ID: NCT07227233

Artificial Intelligence Guided Treatment Selection for Advanced HR+/HER2- Breast Cancer

Artificial Intelligence and Machine Learning-Enhanced Biomarker-dRiven CDK4/6 Inhibitor Rechallenge in HR+ HER2- Advanced Breast Tumors. Scientific Title

Purpose

To see if using an artificial intelligence (AI) tool can help identify who may benefit from taking a second CDK4/6 inhibitor.

Who is this for?

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor that is different from the one you previously took</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> <li class="seamTextUnorderedListItem">Checkups, tests, and questionnaires, monthly</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treatment chosen by the doctor, but will not include CDK4/6 inhibitors</li> <li class="seamTextUnorderedListItem">Checkups, tests, and questionnaires, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Researchers believe that the AI tool will be able to predict who will respond to a second CDK4/6 inhibitor combined with fulvestrant (Faslodex) and that they will have better outcomes (longer progression free survival, higher overall response rate, higher clinical benefit rate, and better quality of life).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07227233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 538 miles
Providence Portland Medical Center
Portland,OR

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05467891

Targeted Therapy and Hormone Therapy for Stage I-III HR+, HER2- Breast Cancer That Has Recurred Locally

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®) CDK 4/6 inhibitor with hormone therapy.

Who is this for?

People with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer that has recurred locally (in the same breast, armpit, chest wall, or some lymph nodes) who have received surgery and/or radiation within the last 6 months. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off for 3 years</li> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: Fulvestrant (Faslodex®), by injection, 2 times in 1 month then monthly for 5 years, or anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®), by mouth, daily for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. They are commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05467891' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</a> </li></ul>

NEAREST SITE: 538 miles
Providence Cancer Institute
Portland,OR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05867251

ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer

A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARTS-021, an experimental CDK2 inhibitor, alone or with other anti-cancer drugs.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) or letrozole (Femara®)</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05867251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/' target='_blank'>Avenzo Therapeutics: ARTS-021 Drug and Trial Information Page</a> </li></ul>

NEAREST SITE: 595 miles
START Mountain Region
West Valley City,UT

VISITS: Number of visits unavailable, up to 2 years

PHASE: I-II

NCT ID: NCT05985655

GTAEXS617 for Advanced HR+ HER2- Breast Cancer

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of GTAEXS617-001 CDK7 inhibitor.

Who is this for?

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GTAEXS617, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GTAEXS617, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blocking CDK7 is expected to slow cancer cell growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05985655' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.exscientia.com/wp-content/uploads/2024/09/Exscientia_617_Sept24.pdf' target='_blank'>Exscientia: GTAEXS617</a> </li></ul>

NEAREST SITE: 595 miles
Biotheryx Investigative Site
West Valley City,UT

VISITS: 1-2 visits every month

PHASE: I

NCT ID: NCT06515470

BTX-9341 CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

A First-in-Human, Open-Label, Dose Escalation and Expansion Trial of BTX-9341 in Participants With Advanced and/or Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of BTX-9341, an experimental CDK4/6 inhibitor, with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

Advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1-2 lines of hormone therapy with CDK4/6 inhibitor. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-9341, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-9341 is an experimental targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06515470' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biotheryx.com/pipeline/' target='_blank'>Biotheryx: BTX-9341 Drug Information Page</a> </li></ul>

NEAREST SITE: 595 miles
START Mountain Region
West Valley City,UT

VISITS: Number of visits unavailable, up to 2 years

PHASE: I

NCT ID: NCT07318805

PF-08032562 for Advanced Breast Cancer

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PF-08032562 and fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose cancer has progressed after receiving prior treatment or for whom no standard treatment options are available. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-08032562, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07318805' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 600 miles
Ironwood Cancer & Research Centers
Goodyear,AZ

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06377852

Increasing Dose of CDK4/6 Inhibitors with Hormone Therapy to Manage Side Effects for People with Metastatic HR+, HER2- Breast Cancer

Comparing Oral Drug Dosing Strategies in Older Patients with Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: the CDK4/6 Inhibitor Dosing Knowledge (CDK) Study Scientific Title

Purpose

To study increasing the dose of CDK4/6 inhibitors to help people manage side effects and continue taking CDK4/6 inhibitors as prescribed.

Who is this for?

People at least 65 years old with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive a CDK4/6 inhibitor with hormone therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regular dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Increasing low dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in group 1, you will continue the normal dose (unless you need to decrease the dose due to challenging side effects).</li> <li class="seamTextUnorderedListItem">If you are in group 2, you will increase your dose every month (unless you have challenging side effects) up to the normal dose.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06377852' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 600 miles
Ironwood Cancer & Research Centers
Goodyear,AZ

VISITS: Number of visits unavailable, up to 5 years

PHASE: III

NCT ID: NCT07062965

PF-07248144 Plus Fulvestrant for Advanced HR+, HER2- Breast Cancer

An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator's Choice of Therapy in Adult Participants With Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of PF-07248144 plus fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed while receiving hormone therapy and/or palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®). You must not have received more than 2 prior lines of therapy for your advanced or metastatic cancer or prior chemotherapy, including antibody-drug conjugates (ADCs). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, by mouth </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), by mouth or fulvestrant (Faslodex®), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144 is a KAT6 inhibitor. KAT6 allows tumor growth to continue.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07062965' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizeroncologydevelopment.com/molecule/kat6-inhibitor#:~:text=PF%2D07248144%20is%20an%20investigational,for%20a%20more%20localized%20activity' target='_blank'>Pfizer: PF-07248144</a> </li></ul>

NEAREST SITE: 656 miles
Northwest Medical Specialties, PLLC
Tacoma,WA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05735080

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of INX-315, an experimental CDK2 inhibitor, alone or with other anti-cancer therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK4/6 inhibitor or CCNE1 amplified breast cancer with no standard treatment options available. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups based on your type of cancer: Group 1: CCNE1 Amplified Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> </ul> Group 2: ER Positive, HER2 Negative Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degrader (SERD) hormone therapy (standard of care)</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitor (standard of care)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degraders (SERD) are a type of hormone therapy that bind to and break down estrogen receptors. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are a type of targeted therapy that block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CCNE1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05735080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://incyclixbio.com/our-science/' target='_blank'>Incyclix Bio Drug Information Page: INX-315</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy and SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 3 visits within 9 months

PHASE: IV

NCT ID: NCT05183828

Effect of HSD3B1 Gene on How Well Letrozole Works for Postmenopausal Women with Stage I-III ER+, HER2- Breast Cancer

Association of HSD3B1 Genotype With Response to Preoperative Letrozole Therapy Among Postmenopausal Women With Estrogen-Receptor Positive (ER+) HER2/Neu-Negative (HER2-) Invasive Ductal Carcinoma (IDC) Scientific Title

Purpose

To study how mutations in the HSD3B1 gene affects how well letrozole (Femara®) hormone therapy treats breast cancer.

Who is this for?

Postmenopausal women with newly diagnosed stage I, stage II, or stage III estrogen receptor positive (ER+ or ER low), HER2 negative (HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, up to 3 months</li> <li class="seamTextUnorderedListItem">Saliva (spit) samples</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mutations in the HSD3B1 gene may decrease how well aromatase inhibitors like letrozole (Femara®) work. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05183828' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: Number of visits unavailable, up to 3 years

PHASE: II

NCT ID: NCT07112053

STEMVAC Experimental Vaccine Plus Hormone Therapy or Capecitabine for Metastatic HR+, HER2- or HER2 Low Breast Cancer

A Phase II Study of STEMVAC Vaccine Therapy for Patients With Hormone Receptor Positive Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine called STEMVAC in combination with standard hormone therapy or capecitabine (Xeloda®).

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer. You must be receiving hormone therapy and a CDK4/6 inhibitor, or have become resistant to hormone therapy and have received at least one cycle of capecitabine (Xeloda®). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1: Hormone Therapy Sensitive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> Group 2: Hormone Therapy Resistant <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> <li class="seamTextUnorderedListItem">FES PET scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The STEMVAC vaccine targets proteins expressed on breast cancer stem cells and may boost the ability of the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Hormone therapy blocks the effects of estrogen to block the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07112053' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: Vaccines for MBC</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 1 visit every week for 6 months, then 1 visit every 2-4 weeks

PHASE: I

NCT ID: NCT05098210

Personalized Vaccine with Immunotherapy for Metastatic HR+, HER2- Breast Cancer

PNV21-001: A Phase I Study of a Personalized Multi-Peptide Neo-Antigen Vaccine in Breast Cancer and PD1/PD-L1 Inhibitor-Refractory Melanoma Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine with immunotherapy.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received at least 1 line of therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly for 2 weeks</li> </ul> followed 2 weeks later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccine, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly, 3 weeks on, 1 week off</li> </ul> followed 6 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized neoantigen peptide vaccines are an experimental type of immunotherapy. The vaccine is designed to target certain proteins (neoantigens) on tumor cells.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Poly ICLC is an immunotherapy that stimulates your immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05098210' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/breast-cancer-vaccine-explainer/' target='_blank'>Breast Cancer Research Foundation: Breast Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Nivolumab (Opdivo®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/poly-iclc' target='_blank'>National Cancer Institute: Poly ICLC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 3 visits in 1 month, then 1 visit every 3 months

PHASE: II

NCT ID: NCT06179303

PET/CT Scan to Predict Response to Abemaciclib for Advanced ER+, HER2- Breast Cancer

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer Scientific Title

Purpose

To study how well functional imaging PET/CT scans with FFNP can predict your cancer's response to abemaciclib (Verzenio®) CDK4/6 inhibitor with standard of care hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+ or ER low), HER2 negative (HER2-) or HER2 low breast cancer who are planning to receive abemaciclib (Verzenio®). You must have received no more than 1 line of chemotherapy for advanced disease. You must not have liver only metastases. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scan with FFNP, by IV, 3 times in 1 month, then every 3 months</li> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 1 day</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">FFNP PET/CT imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that <q>light up</q> with FFNP than a PET scan alone can provide.</li> <li class="seamTextUnorderedListItem">Estradiol is type of hormone therapy for advanced ER+ breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or FISH -.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06179303' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 752 miles
University of Arizona Cancer Center - Prevention Research Clinic
Tucson,AZ

VISITS: 4 visits within 1.5 years

PHASE: II

NCT ID: NCT06184750

Tamoxifen Hormone Therapy to Reduce Breast Density and Breast Cancer Risk for Premenopausal Women

Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial Scientific Title

Purpose

To study the ability of low dose tamoxifen (Nolvadex®) to decrease breast density and breast cancer risk.

Who is this for?

Premenopausal women 18-55 years old who have a history of estrogen receptor positive (ER+) DCIS and have completed treatment at least 3 months ago, who have a history of LCIS, who have received abnormal biopsy results, or who have a high risk for breast cancer. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 6 months to 2 years</li> <li class="seamTextUnorderedListItem">Mammograms, 4 times within 1.5 years</li> <li class="seamTextUnorderedListItem">Questionnaires, 4 times within 1.5 years</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times (optional)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dense breasts are a risk factor for breast cancer.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). It works by blocking the effects of the hormone estrogen in the breast.</li> <li class="seamTextUnorderedListItem">Tamoxifen reduces breast density, even at low doses, and is approved for the prevention of breast cancer.</li> <li class="seamTextUnorderedListItem">The researchers may change your tamoxifen dose according to changes in your breast density as seen on a mammogram.</li> <li class="seamTextUnorderedListItem">DCIS or LCIS are also known as stage 0 breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06184750' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 921 miles
Clinical Trial Site
Santa Fe,NM

VISITS: Number of visits unavailable, up to 3.5 years

PHASE: III

NCT ID: NCT07085767

Palazestrant and Ribociclib Compared to Letrozole and Ribociclib for Advanced ER+, HER2- Breast Cancer

A Phase 3 Randomized, Double-Blind, Active-Controlled Study of Palazestrant With Ribociclib Versus Letrozole With Ribociclib for the First-Line Treatment of ER+, HER2- Advanced Breast Cancer (OPERA-02) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of palazestrant oral SERD/CERAN plus ribociclib (Kisqali®) CDK4/6 inhibitor versus letrozole (Femara®) hormone therapy plus ribociclib (Kisqali®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet received treatment for their advanced cancer. You must not have received fulvestrant (Faslodex®) or elacestrant (Orserdu®) at any time. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Placebo for letrozole (Femara®), by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for palazestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors. Palazestrant is also a CERAN (complete ER antagonist), meaning that it blocks the function of estrogen receptors. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07085767' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/new-hormone-therapies/' target='_blank'>Metastatic Trial Talk: Oral SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/pipeline/' target='_blank'>Olema: Palazestrant</a> </li></ul>

NEAREST SITE: 948 miles
Sarah Cannon Research Institute (Scri) At Health One
Denver,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06120283

BGB-43395 CDK4 Inhibitor Alone or with Hormone Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of BGB-43395, an experimental CDK4 inhibitor, alone or with fulvestrant (Faslodex®) or letrozole (Femara®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received hormone therapy and a CDK4/6 inhibitor. You must not have received more than 2 lines of chemotherapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection or letrozole (Femara®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395 is an experimental targeted therapy called a CDK4 inhibitor. It may block the enzymes CDK4 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal women will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06120283' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/?utm_medium=email&utm_source=subscribers&utm_campaign=Jan2024&utm_content=Email012024' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 1236 miles
Research Site
Pierre,SD

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05774951

CAMBRIA-1: Camizestrant After At Least 2 Years of Hormone Therapy for Stage I-III ER+, HER2- Breast Cancer

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of camizestrant, an experimental hormone therapy, compared to standard of care hormone therapy.

Who is this for?

People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with high or intermediate risk of recurrence. You must have received surgery and 2 to 5 years of hormone therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant, by mouth, for 5 years</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), anastrozole (Arimidex®), or tamoxifen (Nolvadex®), by mouth, for 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05774951' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 1298 miles
Mary Lanning Healthcare ( Site 0019)
Hastings,NE

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06979596

MK-5684 Hormone Therapy for Advanced HR+ Breast Cancer

A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015) Scientific Title

Purpose

To compare the anti-cancer activity of MK-5684 hormone therapy to the standard of care hormone therapy treatment.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed during or after at least one line of hormone therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-5684, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fludrocortisone, by mouth</li> <li class="seamTextUnorderedListItem">Dexamethasone, by mouth</li> </ul> Group 2: Standard of care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of fulvestrant (Faslodex®), by injection, monthly or exemestane (Aromasin®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06979596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: MK-5684</a> </li></ul>

NEAREST SITE: 1482 miles
Texas Oncology Baylor University Medical Center
Dallas,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05573126

EP0062 Hormone Therapy for Advanced ER+, HER2- or HER2 Low, AR+ Breast Cancer

A Modular, Open-Label, Multi-Centre Phase 1/2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 in Patients With Relapsed Locally Advanced or Metastatic AR+/HER2-/ER+ Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of EP0062, an experimental hormone therapy.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low, androgen receptor positive (AR+) breast cancer with no standard treatment options available. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EP0062, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EP0062 is an experimental type of hormone therapy called a selective androgen receptor modulator (SARM) that targets the androgen receptor (AR).</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05573126' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ellipses.life/portfolio/' target='_blank'>Ellipses Pharma: EP0062 Drug Information Page</a> </li></ul>

NEAREST SITE: 1498 miles
Next Oncology Austin
Austin,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07222267

BG-75202 in Combination With Other Therapies for HR+, HER2- Advanced Breast Cancer

A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75202, Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of BG-75202 KAT6A/B inhibitor alone and in combination with other therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1 to 3 prior lines of therapy. You must not have received more than 2 lines that included chemotherapy and/or an antibody-drug conjugate (ADC). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BG-75202, by mouth</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BG-75202 is a KAT6A/B inhibitor. KAT6 allows tumor growth to continue.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow. CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07222267' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1500 miles
University of Kansas Cancer Center
Kansas City,KS

VISITS: At least 2 visits in 6 months

PHASE: II

NCT ID: NCT06195306

Tamoxifen With or Without Omega-3 Fatty Acids to Reduce the Risk of Breast Cancer for Overweight Postmenopausal Women

Phase 2 Study of Low Dose Tamoxifen +/- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer Scientific Title

Purpose

To study if tamoxifen (Nolvadex®) hormone therapy with or without omega-3 fatty acids decreases breast cancer risk in postmenopausal women who are overweight or obese.

Who is this for?

Postmenopausal women 45-65 years old who are overweight or obese and have at least 1 of the following breast cancer risk factors: abnormal biopsy results; history of DCIS (stage 0) or LCIS (stage 0); dense breasts; family history of breast cancer; or a mutation in ATM, BARD1, CDH1, CHEK2, NF1, PTEN, RAD51C, RAD51D, or STK11. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Tamoxifen Alone <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Mammogram, 1 time</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times in 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Tamoxifen with Omega-3 Fatty Acids <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Omega-3 fatty acids (Lovaza®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Mammogram, 1 time</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times in 6 months</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Tamoxifen is approved by the FDA for preventing breast cancer in women at increased risk. </li> <li class="seamTextUnorderedListItem">Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver and may help prevent cancer in overweight or obese individuals.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06195306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/9785-tamoxifen' target='_blank'>Cleveland Clinic: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 1509 miles
UT Southwestern Medical Center
Dallas,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05693766

Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT) Scientific Title

Purpose

To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy and capecitabine (Xeloda®) chemotherapy and use MammaPrint® and BluePrint tests to guide treatment decisions.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received treatment with hormone therapy and a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a PIK3CA mutation. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">This trial is for people with non-Luminal A breast cancer. Luminal A breast cancer is ER+, PR+, and HER2- with low Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>

NEAREST SITE: 1509 miles
University of Texas, Southwestern
Dallas,TX

VISITS: 1 visit every month

PHASE: II

NCT ID: NCT05919108

Neratinib Targeted Therapy with Hormone Therapy Before Surgery for Stage I-III ER+, HER2-, HER2 Mutated Lobular Breast Cancer

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) Neratinib (Nerlynx®) anti-HER2 targeted therapy with standard of care hormone therapy.

Who is this for?

People with newly diagnosed stage I, stage II, or stage III estrogen receptor positive (ER+ or ER low), HER2 negative (HER2- or HER2 low), HER2 mutated lobular breast cancer who have not yet received treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, 5 months</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 5 months</li> <li class="seamTextUnorderedListItem">Mammogram, ultrasound, or breast MRI</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 1 month</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, 5 months</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 5 months</li> <li class="seamTextUnorderedListItem">Mammogram, ultrasound, or breast MRI</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells. It targets and blocks HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is IHC 1+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05919108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li></ul>

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05501704

Hormone Therapy Before Surgery for Men with Stage I-III ER+, HER2- Breast Cancer

ETHAN: A Phase II Study Comparing Different Endocrine THerapies for mAle Breast caNcer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) hormone therapy for male breast cancer.

Who is this for?

Men with newly diagnosed stage I, stage II, or stage III hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have not yet received treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

This trial has two parts. In part 1, you will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, 1 time</li> </ul> In part 2, you will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 4 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 4 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, monthly for 4 months</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, monthly for 4 months</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 4 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. Tamoxifen is the standard of care for the treatment of breast cancer in men.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow. Anastrozole is a standard treatment in women with breast cancer and works more effectively than tamoxifen.</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®) is approved to treat prostate cancer. It lowers the body's production of testosterone. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501704' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials/22-225' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/degarelix.html' target='_blank'>Drugs.com: Degarelix (Firmagon®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

NEAREST SITE: 1643 miles
Houston Methodist Cancer Center
Houston,TX

VISITS: 2 visits the first month, then 1 visit a month, ongoing

PHASE: II

NCT ID: NCT05305924

Fulvestrant With Abemaciclib for ER+ or ER Low, HER2- Metastatic Breast Cancer

Multicenter Randomized Phase II Trial of Fulvestrant Plus Abemaciclib With or Without Run-in of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer After Failure of a CDK4/6 Inhibitor In Combination With an Aromatase Inhibitor Scientific Title

Purpose

To determine if stopping treatment with abemaciclib (Verzenio®) for 1 month (called a drug holiday) improves the effects (good and bad) and anti-cancer activity of abemaciclib (Verzenio®) with fulvestrant (Faslodex®).

Who is this for?

Women with metastatic (stage IV) ER positive (ER+) or ER Low (1%-10% ER), HER2 negative (HER2-) breast cancer that has progressed on a CDK4/6 inhibitor in combination with an aromatase inhibitor immediately before enrolling in this study. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then once a month </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">A drug holiday is a planned period of time that you decide with your doctor to stop taking a medication. In some cases, a drug holiday can allow a medication to become effective again.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put you in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305924' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/drug-holiday-definition-risks-and-benefits-2248870' target='_blank'>Verywell Health: Drug Holiday</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/pathology-report/hormone-receptor-status' target='_blank'>Breastcancer.org: Hormone Receptor Status</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Every 2 weeks for 3 months

PHASE: II

NCT ID: NCT05035836

Neoadjuvant Zanidatamab Targeted Therapy with Hormone Therapy for Stage I-III HER2+ Breast Cancer

A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental anti-HER2 targeted therapy, with letrozole (Femara®) and tamoxifen (Nolvadex®) hormone therapies before surgery (neoadjuvant).

Who is this for?

Women with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who have not yet received treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25), by IV, every 2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25) is an experimental anti-HER2 targeted therapy and bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035836' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zymeworks.com/pipeline#zanidatamab' target='_blank'>Zymeworks Drug Information Page: Zanidatamab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 1643 miles
Research Site
Houston,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT06188520

AZD8421 CDK2 Inhibitor with Hormone Therapy and CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase I/IIa, First-in-human, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (CYCAD-1) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AZD8421, an experimental CDK2 inhibitor, with camizestrant, an experimental SERD, and a CDK4/6 inhibitor.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and/or palbociclib (Ibrance®), by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421 is an experimental type of targeted therapy called a CDK2 inhibitor. CDK2 inhibitors may block the enzyme CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06188520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html' target='_blank'>AstraZeneca: AZD8421 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li></ul>

NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI

VISITS: 1 visit every 3 to 4 weeks, ongoing

PHASE: I

NCT ID: NCT04174352

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation

A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations Scientific Title

Purpose

To study if FES-PET/CT scans can help find a personalized dose of tamoxifen (Nolvadex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that tests positive for a ESR1 mutation. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">FES PET/CT scan, every 3 to 4 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">ESR1 mutations in breast cancer may affect how well tamoxifen works against tumor cells. </li> <li class="seamTextUnorderedListItem">Tracers are chemicals that are used to find cancer cells in the body during a PET scan. The imaging trial will use the tracer fluoroestradiol (FES)--it finds estrogen receptors in breast tumors. </li> <li class="seamTextUnorderedListItem">The FES tracer may also show how tamoxifen is affecting your tumors. Researchers may use this information to increase your dose of tamoxifen.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04174352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/hormonal-therapy-metastatic-breast-cancer' target='_blank'>ASCO Cancer.net: Hormonal Therapy for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/more-effective-therapies-needed-for-patients-with-esr1mutated-breast-cancer' target='_blank'>Targeted Oncology: More Effective Therapies Needed For Patients With ESR1-Mutated Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.karger.com/Article/FullText/481428' target='_blank'>Journal Article: Are We Ready to Use ESR1 Mutations in Clinical Practice</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ijcem.com/files/ijcem0076055.pdf' target='_blank'>Journal Article: The Role of PET Imaging Probes for Early Monitoring the Response to Tamoxifen</a> </li></ul>

NEAREST SITE: 1739 miles
Washington University School of Medicine
St Louis,MO

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05837455

Biomarkers to Guide Therapy Before Surgery for Stage II-III ER+, HER2- Breast Cancer

NeoTAILOR: A Phase II Biomarker-directed Approach to Guide Neoadjuvant Therapy for Patients With Stage II/III ER-positive, HER2-negative Breast Cancer Scientific Title

Purpose

To study the effects (good and bad) of whether a novel biomarker-driven approach can be used to guide selection of treatment before surgery (neoadjuvant).

Who is this for?

Postmenopausal women with newly diagnosed stage II or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Biomarker tests</li> <li class="seamTextUnorderedListItem">Surgery</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Biomarker tests</li> <li class="seamTextUnorderedListItem">Surgery</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast MRI scan, 2 times</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Biomarker tests</li> <li class="seamTextUnorderedListItem">Chemotherapy with an anthracycline drug, by IV, and/or a taxane, by IV, for up to 6 months</li> <li class="seamTextUnorderedListItem">Surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person that tell doctors something about that person’s health.</li> <li class="seamTextUnorderedListItem">Using biomarkers to select treatment may improve the clinical response and identify those who may not require chemotherapy before surgery (neoadjuvant).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05837455' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1739 miles
Washington University School of Medicine
St Louis,MO

VISITS: Visits every 3-6 months, up to 2 years

PHASE: II

NCT ID: NCT02476786

Hormone Therapy With or Without Other Treatment for Women 70 and Older With Low Risk Breast Cancer

Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score Scientific Title

Purpose

To study the effects (good and bad) of giving neoadjuvant hormone therapy to see if surgery (lumpectomy or mastectomy) can be avoided.

Who is this for?

Women 70 or older with stage I or stage II estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not had surgery. Your tumor must be of a slow growing type that is at low risk for a recurrence. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doctor's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Office visit to assess your tumor, every 3 to 6 months, for up to 2 years</li> <li class="seamTextUnorderedListItem">Surgery, chemotherapy and/or radiation, if your tumor starts to grow or you want to have these treatments</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oncotype DX test on tumor sample (biopsy)</li> <li class="seamTextUnorderedListItem">3 quality of life questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your doctor will choose the hormone therapy drug you will receive: goserelin (Zoladex®), anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), fulvestrant (Faslodex®), or tamoxifen (Nolvadex®).</li> <li class="seamTextUnorderedListItem">You will not have surgery, radiation, or chemotherapy unless your tumor starts to grow or you decide you want to have these treatments.</li> <li class="seamTextUnorderedListItem">Ki67 is a protein found in cancer cells.</li> <li class="seamTextUnorderedListItem">By measuring the amount of the Ki67 protein in your cancer cells, researchers can learn how quickly the cancer cells are growing.</li> <li class="seamTextUnorderedListItem">To enroll in this study, researchers must determine that your cancer is slow growing.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02476786' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/diagnosis/rate_grade' target='_blank'>Breastcancer.org: Ki-67</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/symptoms/testing/types/oncotype_dx' target='_blank'>Breastcancer.org: Oncotype DX Test</a> </li></ul>

NEAREST SITE: 1761 miles
University of Wisconsin
Madison,WI

VISITS: Every 3 weeks for 6 months

PHASE: II

NCT ID: NCT04886531

Targeted Therapy and Hormone Therapy Before Surgery for Stage I-III Triple Positive Breast Cancer

An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in Triple Positive Breast Cancers Hoosier Cancer Research Network BRE17-141 Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) and trastuzumab (Herceptin®) anti-HER2 targeted therapies with letrozole (Femara®) or anastrozole (Arimidex®) hormone therapies before surgery (neoadjuvant).

Who is this for?

Postmenopausal women and men with stage I, stage II, or some stage III triple positive (ER+, PR+, HER2+) breast cancer who have not yet received surgery. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> </ul> followed 3 weeks later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> followed 3 weeks later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> followed 3 weeks later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) and trastuzumab (Herceptin®) are anti-HER2 targeted therapies used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are a type of hormone therapy called aromatase inhibitors. They are commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04886531' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li></ul>

NEAREST SITE: 1832 miles
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee,WI

VISITS: At least 2 visits within 1-3 months

PHASE: II

NCT ID: NCT06361940

Biomarkers to Predict Hormone Therapy Resistance for Women with Stage I-II HR+, HER2-, Node Negative Breast Cancer

Molecular Analyses to Predict Pathways of Endocrine Resistance Following Short Term Neoadjuvant Endocrine Treatment in Patients with Hormone Receptor-Positive HER2-negative Breast Cancer (MAPPER) Scientific Title

Purpose

To use biomarkers to predict how hormone therapy resistance occurs and identify new hormone therapy targets.

Who is this for?

Women with newly diagnosed stage I or stage II hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-), node negative breast cancer who have not yet received treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy</li> <li class="seamTextUnorderedListItem">Biomarker tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biomarkers are genes, molecules, or other features present in a person, including in a person’s tumor, that tell doctors something about a person’s health condition.</li> <li class="seamTextUnorderedListItem">People with HR+, HER2-, node negative breast cancer usually receive surgery followed by chemotherapy, if needed, in addition to hormone therapy.</li> <li class="seamTextUnorderedListItem">Because hormone therapy is usually given after surgery (adjuvant), the ability to study the tumor response to hormone therapy is challenging.</li> <li class="seamTextUnorderedListItem">This study offers the unique opportunity to study hormone therapy before surgery (neoadjuvant).</li> <li class="seamTextUnorderedListItem">Node negative means cancer has not spread to your lymph nodes.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06361940' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1856 miles
Northwestern University
Chicago,IL

VISITS: 5 visits within 5 years

PHASE: II

NCT ID: NCT06062498

Elacestrant Compared to Elacestrant Plus a CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer

Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy alone or combined with a CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received at least 2 types of hormone therapy, at least one of which was received in combination with a CDK4/6 inhibitor for your advanced or metastatic cancer. You must not have received elacestrant (Orserdu®). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">You will receive a CDK4/6 inhibitor that you have not previously received.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®). In this study, abemaciclib (Verzenio®) is received daily. Palbociclib (Ibrance®) and ribociclib (Kisqali®) are received daily, 3 weeks on, 1 week off.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06062498' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.orserdu.com/' target='_blank'>Menarini: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/hormone-therapy-resistance/' target='_blank'>Metastatic Trial Talk: Treatments to Overcome Resistance to Hormone Therapy</a> </li></ul>

NEAREST SITE: 1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN

VISITS: Every 1-3 weeks for 6 months

PHASE: II

NCT ID: NCT07016399

Darolutamide With Standard Therapy or Standard Therapy Alone Before Surgery for Stage II-III Androgen Receptor Positive Triple Negative Breast Cancer

A Phase II Neoadjuvant Clinical Trial of the Androgen Receptor Inhibitor Darolutamide in Early-Stage Androgen Receptor Positive (AR+) Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of darolutamide (Nubeqa®) androgen receptor inhibitor plus standard therapy versus standard therapy alone before surgery (neoadjuvant).

Who is this for?

People with newly diagnosed stage II or some stage III androgen receptor positive (AR+), triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) or epirubicin (Ellence®), every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> <li class="seamTextUnorderedListItem">Ultrasound or MRI scan</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsies</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®), by mouth, for 2 weeks</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®), by mouth, for 3 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly for 3 months </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) or epirubicin (Ellence®), every 3 weeks for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li> <li class="seamTextUnorderedListItem">Ultrasound or MRI scan</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®) is an androgen receptor inhibitor. It blocks the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving darolutamide plus standard therapy before surgery (neoadjuvant) may make the tumor smaller and may reduce the amount of normal tissue that needs to be removed.</li> <li class="seamTextUnorderedListItem">Darolutamide (Nubeqa®) is FDA approved to treat prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, AR positive is defined as ≥80% staining for AR by immunohistochemistry.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07016399' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nubeqa-us.com/?utm_source=google&utm_medium=cpc&utm_campaign=NUB_DTC_cpc_google_BRN&utm_content=BRN_X_ALL_PHR_X_X&utm_term=darolutamide&gclsrc=aw.ds&gad_source=1&gad_campaignid=15641610910&gbraid=0AAAAACsxACzBEW_NkuB-pBDxOeDA5KvDu&gclid=Cj0KCQ' target='_blank'>Bayer: Darolutamide (Nubeqa®)</a> </li></ul>

NEAREST SITE: 1959 miles
Tennessee Oncology PLLC
Nashville,TN

VISITS: Number of visits unavailable, up to 2 years

PHASE: I-II

NCT ID: NCT07288359

GVV858 in Combination With Fulvestrant for Advanced HR+, HER2- Breast Cancer

An Open-label, Multi-center, Phase I/II Study of GVV858 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer and Other Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of GVV858 in combination with fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed on or after hormone therapy in combination with a CDK4/6 inhibitor. You must not have received more than 2 lines of hormone therapy. You must not have received chemotherapy, or an antibody-drug conjugate (ADC) for advanced disease. Your tumor must have an abnormality called CCNE1 amplification. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GVV858</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07288359' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 1959 miles
Sarah Cannon Research Institute
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05187832

AND019 for Postmenopausal Women with Advanced ER+, HER2- Breast Cancer

A Phase I Dose Escalation and Dose Expansion Study of AND019 in Patients With Estrogen Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced or Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AND019, an experimental hormone therapy.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received standard treatment with at least 1 line of hormone therapy and no more than 1 line of chemotherapy for advanced/metastatic disease. You must not have received treatment with fulvestrant (Faslodex®) or any other SERD. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AND019, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AND019 is an experimental hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05187832' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/selective-estrogen-receptor-degrader-and019' target='_blank'>National Cancer Institute: AND019</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>

NEAREST SITE: 2054 miles
University of Michigan Comprehensive Cancer Center
Ann Arbor,MI

VISITS: Monthly for 6 months

PHASE: II

NCT ID: NCT07158021

Leuprolide or Goserelin to Reduce Estrogen for Pre- or Peri-Menopausal Women With Stage I-IV Breast Cancer

Phase 2 Randomized Trial to Examine Ovarian Function Suppression for Breast Cancer (OFS) Scientific Title

Purpose

To compare a low dose of leuprolide (Lupron®), a high dose of leuprolide (Lupron®), and goserelin (Zoladex®) for their ability to reduce estrogen production.

Who is this for?

Pre-menopausal or peri-menopausal women with stage I, stage II, stage III, or stage IV (metastatic) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive a gonadotropin releasing hormone (GnRH) agonist plus hormone therapy. You must have completed chemotherapy if recommended. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide (Lupron®), low dose, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Blood tests</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide (Lupron®), high dose, by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Blood tests</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®), by injection, monthly for 6 months</li> <li class="seamTextUnorderedListItem">Blood tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide (Lupron®) and goserelin (Zoladex®) are given to pre-menopausal and peri-menopausal women with HR+ breast cancer. These drugs block the ability of the ovaries to make estrogen, which causes HR+ breast cancer to grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07158021' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zoladex.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=22507845007&gbraid=0AAAAA_gRoNBb5XSY7s8DD7IIxTBZtXTv6&gclid=Cj0KCQiAoZDJBhC0ARIsAERP-F-ABUsC3lGhM3VH4Nc4qtBUZY8e6bBS1dm4GjfxXphAdMMFnwMJfWgaAkRAEALw_wcB' target='_blank'>AstraZeneca: Goserelin (Zoladex®)</a> </li></ul>

NEAREST SITE: 2108 miles
Ohio State University Comprehensive Cancer Center
Columbus,OH

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04923542

Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases

Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity and side effects of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®), hormone therapy, and stereotactic radiation therapy together to treat brain metastases.

Who is this for?

People with metastatic (stage IV) hormone receptor-positive, HER2 negative (HER2-) breast cancer that has spread to the brain. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiation Therapy to each brain met</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. This stops cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Anti-estrogen therapies are commonly used to treat hormone receptor-positive breast cancer. These drugs are also called endocrine or hormone therapy and include tamoxifen, aromatase inhibitors, fulvestrant, and others. </li> <li class="seamTextUnorderedListItem">The hormone therapies used in this trial are fulvestrant and aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04923542' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/?s=brain+mets' target='_blank'>Metastatic Trial Talk: Topics for Breast Cancer Brain Mets</a> </li></ul>

NEAREST SITE: 2135 miles
Emory Saint Joseph's Hospital
Atlanta,GA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05464810

Letrozole Hormone Therapy Alone or With Simvastatin Before Surgery for Postmenopausal Women with Stage I-III HR+, HER2-/HER2 Low Breast Cancer

A Randomized Window of Opportunity Study of Preoperative Letrozole and Simvastatin Versus Letrozole Alone in Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of letrozole (Femara®) hormone therapy alone or with simvastatin (Zocor®), a cholesterol drug.

Who is this for?

Postmenopausal women with stage I, stage II, or stage III hormone receptor positive (HR+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received surgery. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 weeks</li> <li class="seamTextUnorderedListItem">Simvastatin (Zocor®), by mouth, daily for 2 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer. </li> <li class="seamTextUnorderedListItem">Simvastatin (Zocor®) is a type of drug called a statin that is used to lower bad cholesterol and raise good cholesterol. The use of statins in people with breast cancer may improve survival.</li> <li class="seamTextUnorderedListItem">Letrozole and simvastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The addition of simvastatin to letrozole may be more effective at stopping the growth of cancer cells than letrozole alone.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05464810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a692030.html' target='_blank'>MedlinePlus: Simvastatin (Zocor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/981725' target='_blank'>Medscape: Statin Use in Breast Cancer</a> </li></ul>

NEAREST SITE: 2264 miles
UPMC Magee Womens Hospital
Pittsburgh,PA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06218303

Vaccine to Prevent Breast Cancer for Women with ER+ DCIS

A Clinical Study of a Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ Scientific Title

Purpose

To study the safety and ability of an experimental MUC1 peptide vaccine to prevent breast cancer in people with DCIS.

Who is this for?

Postmenopausal women with stage 0 (DCIS) estrogen receptor positive (ER+) breast cancer who are planning to receive surgery. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MUC1 peptide vaccine with Poly ICLC (Hiltonol®), by injection, 3-4 times within 3-9 months</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth, daily</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Not all DCIS will progress to invasive breast cancer.</li> <li class="seamTextUnorderedListItem">Vaccines for DCIS may allow for less treatment. </li> <li class="seamTextUnorderedListItem">The MUC1 peptide vaccine is an experimental immunotherapy. The vaccine targets MUC1, which is a protein expressed by DCIS.</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol®) is an immunotherapy that stimulates immune cells to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06218303' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY

VISITS: 1 visit every month

PHASE: II

NCT ID: NCT06434064

Tamoxifen Hormone Therapy and Liposomal Doxorubicin Chemotherapy for Advanced Triple Negative Breast Cancer

A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of tamoxifen (Nolvadex®) hormone therapy with pegylated liposomal doxorubicin (Doxil®) chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR-, HER2- or HER2 low) breast cancer who have received at least 2 lines of therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pegylated liposomal doxorubicin (Doxil®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Electrocardiogram (ECG)</li> <li class="seamTextUnorderedListItem">CT scan or MRI scan</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen which may help stop the growth of tumor cells that need estrogen to grow.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a type of chemotherapy drug that damages cancer cell DNA and blocks a protein (enzyme) needed for cancer cell division and DNA repair.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin is a form of the drug that is contained inside very tiny, fat-like particles.</li> <li class="seamTextUnorderedListItem">Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. </li> <li class="seamTextUnorderedListItem">Giving tamoxifen and pegylated liposomal doxorubicin together may work better than giving either drug alone.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">An electrocardiogram (ECG) is a way of recording the heart's electrical activity.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is IHC 1+ or IHC 2+/FISH-.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06434064' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/pegylated-liposomal-doxorubicin' target='_blank'>Cancer Research UK: Pegylated Liposomal Doxorubicin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>

NEAREST SITE: 2371 miles
University of Virginia
Charlottesville,VA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06507618

Hormone Therapy Before Lumpectomy to Help Make Radiation Decisions for Older Women with Stage I-III ER+, HER2- Breast Cancer

A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II) Scientific Title

Purpose

To study if hormone therapy before lumpectomy helps older women make decisions about receiving radiation.

Who is this for?

Women at least 65 years old with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who are planning to receive a lumpectomy. You must not have cancer in your lymph nodes. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Hormone Therapy and Lumpectomy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lumpectomy</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2: Lumpectomy Only <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lumpectomy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The standard of care treatment for stage I-III ER+ breast cancer is lumpectomy (also called breast conserving surgery), radiation, and then 5-10 years of hormone therapy.</li> <li class="seamTextUnorderedListItem">Radiation is sometimes not needed for women 65 years or older. </li> <li class="seamTextUnorderedListItem">Hormone therapy is needed but sometimes not completed because of side effects.</li> <li class="seamTextUnorderedListItem">A previous study showed that taking hormone therapy for 3 months before lumpectomy helped with decision-making about omitting radiation and continuing to receive hormone therapy after surgery.</li> <li class="seamTextUnorderedListItem">In this trial, the hormone therapy drugs are tamoxifen (Nolvadex®), letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">A lumpectomy is sometimes called a partial mastectomy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06507618' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT07285044

Receiving Cancer Treatment at Home Instead of in the Clinic for Stage I-IV Breast Cancer

Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas Scientific Title

Purpose

To study whether providing cancer treatment in the home is preferred over the traditional clinic setting.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who live in the Florida panhandle area, who are receiving and tolerating standard treatment for their cancer, and who plan to continue to receive these medications for the next 3 months or more. You must not be receiving all your medications by mouth. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In-home standard of care cancer treatment through CCBW, up to 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times within 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Typically, drug-related cancer treatment is provided at a medical center, which causes patients to have to spend time away from their family and friends. Treatment at a medical center may contribute to the physical, emotional, social, and financial burden of having cancer.</li> <li class="seamTextUnorderedListItem">The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team to provide cancer treatment in the patient's home and may be preferred over the traditional clinic setting.</li> <li class="seamTextUnorderedListItem">At the end of the 3 months of the trial, participants may choose to continue to receive in-home treatment for another 3 months or return to the clinic.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07285044' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: Weekly for 2 months then monthly for 3 months

PHASE: I

NCT ID: NCT06691035

Dendritic Cell Vaccine and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of an experimental dendritic cell vaccine with elacestrant (Orserdu®) hormone therapy.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2- or HER2 low) breast cancer with ESR1 mutations. You must have received a CDK4/6 inhibitor with hormone therapy for metastatic disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 2 months then monthly for 3 months</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after cancer cells with ESR1 mutations, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06691035' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06409390

Studying a New Order of Giving Currently Approved Drugs for Women with HR+, HER2- Breast Cancer

A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer Scientific Title

Purpose

To study a new order of giving currently approved drugs to treat metastatic breast cancer.

Who is this for?

Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor or tamoxifen (Nolvadex®). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) or trastuzumab deruxtecan (Enhertu®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) or abemaciclib (Verzenio®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are continually developing new drugs to treat metastatic breast cancer (MBC) and understanding how to best use drugs already approved for MBC.</li> <li class="seamTextUnorderedListItem">An important question in treatment planning is the order in which drugs are given, called “drug sequencing”.</li> <li class="seamTextUnorderedListItem">All drugs in this trial are approved for metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), docetaxel (Taxotere®), and capecitabine (Xeloda®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) and trastuzumab deruxtecan (Enhertu®) are types of targeted therapy called antibody drug conjugates (ADC).</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06409390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/drug-sequencing/?utm_medium=email&utm_source=subscribers&utm_campaign=Mar2024&utm_content=Email032024' target='_blank'>Metastatic Trial Talk: What is “Drug Sequencing”?</a> </li></ul>

NEAREST SITE: 2406 miles
University of North Carolina
Chapel Hill,NC

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05472792

Hormone Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Stage IA HR+, HER2- or HER2 Low Breast Cancer

Comparison of Adjuvant Monotherapy With Endocrine Therapy or Accelerated Partial Breast Irradiation Following Lumpectomy for Low Risk Breast Cancer Patients Over 65 (CAMERAN) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of accelerated partial breast irradiation alone compared to hormone therapy alone after lumpectomy.

Who is this for?

Women, age 65 and older, with stage IA hormone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) or HER2 low breast cancer who have received a lumpectomy. You must not be receiving chemotherapy, hormone therapy, or hormone replacement therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), exemestane (Aromasin®), letrozole (Femara®), fulvestrant (Faslodex®), or toremifene (Fareston®), daily, for up to 5 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Accelerated partial breast irradiation, 5 times within 10 days</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li> <li class="seamTextUnorderedListItem">Accelerated partial breast irradiation is a treatment option available to women considered to have early stage, low-risk breast cancer.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) and toremifene (Fareston®) are types of hormone therapy called selective estrogen receptor modulators (SERMs). SERMs work by blocking the activity of estrogen. </li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of anti-estrogen therapy called aromatase inhibitors. They are commonly used to treat early-stage and metastatic hormone-positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05472792' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy/external#section-accelerated-partial-breast-radiation' target='_blank'>Breastcancer.org: Accelerated Partial Breast Irradiation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 2436 miles
George Washington-Medical Faculty Associates
Washington D.C.,DC

VISITS: Up to 1 year

PHASE: II

NCT ID: NCT06806930

Different Amounts of Time of Hormone Therapy Before Surgery for Stage I-III ER+, HER2- or HER2 Low Breast Cancer

Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT) Scientific Title

Purpose

To study how the amount of time receiving hormone therapy before surgery (neoadjuvant) affects breast cancer.

Who is this for?

People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer who are planning to receive hormone therapy before surgery (neoadjuvant). Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 3 groups: Group 1: Short Amount of Time <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, up to 2 months</li> </ul> Group 2: Medium Amount of Time <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, 2-6 months</li> </ul> Group 3: Long Amount of Time <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy, by mouth, 6 months-1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like hormone therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06806930' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 1 visit every month

PHASE: I-II

NCT ID: NCT06110793

Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer

A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable, up to 6 months

PHASE: II

NCT ID: NCT07483307

Endocrine Therapy Before Surgery for Invasive Lobular Breast Cancer

Impact of Neoadjuvant Endocrine Therapy on Surgical Outcomes in Patients With Stage 2 to 3 Invasive Lobular Carcinoma: A Prospective Study Scientific Title

Purpose

To study if hormone-blocking therapy before surgery (called neoadjuvant endocrine therapy) can shrink tumors and reduce the chance of cancer cells being left at the edges of tissue removed (positive margins) during breast-conserving surgery.

Who is this for?

Postmenopausal women 50 or older with stage II or some stage III, estrogen receptor positive (ER+), HER2 negative (HER2-) invasive lobular breast cancer (ILC), who are planning to have breast-conserving surgery (lumpectomy). You must not have received neoadjuvant (before surgery) treatment. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), or tamoxifen (Nolvadex®), daily, before surgery, up to 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive endocrine therapy before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Your doctor will choose the hormone therapy drug you will receive: anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), or tamoxifen (Nolvadex®)</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. Tamoxifen is the standard of care for the treatment of breast cancer in men.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), Letrozole (Femara®) and Exemestane (Aromasin®), are types of hormone therapy called an aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow. They are commonly used to treat hormone receptor positive breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07483307' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen: What to Expect, Side Effects, and More</a> </li></ul>

NEAREST SITE: 2545 miles
RWJBarnabas Health - Robert Wood Johnson University Hospital Somerset
Somerville,NJ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06139107

Radiation, Abemaciclib, and Letrozole Before Surgery for Postmenopausal Women with Stage I-III HR+, HER2- Breast Cancer

RADIANT Study: Pre-op Radiation With Abemaciclib Andletrozole in Early Stage Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) radiation with abemaciclib (Verzenio®) CDK4/6 inhibitor and letrozole (Femara®) aromatase inhibitor.

Who is this for?

Postmenopausal women with stage I, stage II, or some stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received surgery and are not planning to receive chemotherapy before surgery (neoadjuvant). You must have an Oncotype DX score of less than 25. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 3 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 2 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 months</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">The Oncotype DX test can help determine the chance of the cancer coming back.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with lobular breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06139107' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York,NY

VISITS: 2 visits within 2 weeks

PHASE: NA

NCT ID: NCT06127979

Studying Changes in Ki67 Expression Before and After Hormone Therapy for Women with Stage I-III ER+, HER2- Breast Cancer

Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy Scientific Title

Purpose

To study changes in Ki67 before and after hormone therapy, which may suggest response to treatment.

Who is this for?

Women with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet received surgery. You must not be planning to receive neoadjuvant (before surgery) chemotherapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy, before and during surgery</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Blood tests</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ki67 is a protein found in cancer cells.</li> <li class="seamTextUnorderedListItem">By measuring the amount of the Ki67 protein in your cancer cells, researchers can learn how quickly the cancer cells are growing.</li> <li class="seamTextUnorderedListItem">The researchers are also looking at how Ki67 levels change in people with and without a mutation in BRCA2.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06127979' target='_blank'>ClinicalTrials.gov</a> </li></ul>

100

NEAREST SITE: 2568 miles
Mount Sinai - West
New York,NY

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05095207

Abemaciclib With Bicalutamide for Androgen Receptor+, HER2- Advanced Breast Cancer

A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) together with bicalutamide (Casodex®), an anti-androgen drug.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) androgen receptor positive (AR+) HER2 negative breast cancer. You must have received at least one line of therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>

101

NEAREST SITE: 2574 miles
Montefiore Einstein Comprehensive Cancer Center
The Bronx,NY

VISITS: 6 visits within 2 years

PHASE: II

NCT ID: NCT06923527

Elacestrant Oral SERD for Stage II-III ctDNA-Positive, ER+, HER2- Breast Cancer

A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) oral SERD in people who test positive for circulating tumor DNA (ctDNA).

Who is this for?

People with stage IIB or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer whose diagnosis was 5-15 years ago and who have completed hormone therapy. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA blood test</li> </ul> followed by (if ctDNA test is positive): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, for 1 year</li> <li class="seamTextUnorderedListItem">ctDNA testing, every 3 months for 1 year</li> <li class="seamTextUnorderedListItem">CT scan, every 3 months for 1 year</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA testing, every 6 months for 1 year</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, or hormone therapy, for 1 year</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06923527' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://stemline.com/product-pipeline/' target='_blank'>Stemline Therapeutics: Elacestrant (Orserdu®)</a> </li></ul>

102

NEAREST SITE: 2614 miles
Yale University
New Haven,CT

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06953882

Option to Omit Chemotherapy for Stage II-III ER+, HER2- Breast Cancer

SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy Scientific Title

Purpose

To study whether choosing not to receive chemotherapy after surgery increases the chances of completing treatment with ribociclib (Kisqali®), a CDK 4/6 inhibitor.

Who is this for?

People with stage II or some stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an Oncotype DX Recurrence Score ≤ 25 who are planning to receive ribociclib (Kisqali®) and hormone therapy. You must have received surgery and cancer was found in your lymph nodes. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will choose to be in 1 of 2 groups: Group 1: No chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off, for 1 year</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily, for 1 year</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®) (if male or premenopausal female only), by injection, monthly, for 1 year</li> </ul> Group 2: With Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy, for 1 year</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off, for 1 year</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily, for 1 year</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®) (if male or premenopausal female only), by injection, monthly, for 1 year</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In clinical trials, around one-third of patients stopped taking CDK 4/6 inhibitors before it was planned due to side effects.</li> <li class="seamTextUnorderedListItem">The OncotypeDx 21-gene Breast Recurrence Score Test is a biomarker test that predicts the benefit of chemotherapy in certain people with breast cancer.</li> <li class="seamTextUnorderedListItem">An OncotypeDx recurrence score of 0-25 indicates a less aggressive cancer that will not benefit from chemotherapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06953882' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.exactsciences.com/cancer-testing/oncotype-dx-breast-recurrence-score-patients/test-results' target='_blank'>Exact Sciences: Oncotype DX Breast Recurrence Score Test</a> </li></ul>

103

NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH

VISITS: 1 visit every month

PHASE: II

NCT ID: NCT05933395

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.

Who is this for?

Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 4 groups based on biomarker testing results: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>

104

NEAREST SITE: 2619 miles
Dartmouth Cancer Center
Lebanon,NH

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05900895

Estradiol Hormone Therapy and Olaparib Targeted Therapy for Postmenopausal Women with Advanced ER+, HER2- Breast Cancer

Phase 1b Study of Olaparib and Estradiol in Advanced ER+ Breast Cancer (PHOEBE) Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of olaparib (Lynparza®) PARP inhibitor with estradiol (Estrace®) hormone therapy.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received at least 1 line of hormone therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 2 months</li> <li class="seamTextUnorderedListItem">17b-estradiol (Estrace®), by mouth, daily for 2 months</li> </ul> followed 2 months later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol (Estrace®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Estradiol (Estrace®) is a type of hormone therapy for advanced ER+ breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05900895' target='_blank'>ClinicalTrials.gov</a> </li></ul>

105

NEAREST SITE: 2619 miles
Dartmouth-Hitchcock Medical Center
Lebanon,NH

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05716516

Estradiol Hormone Therapy for Postmenopausal Women with Advanced ER+ Breast Cancer

Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of estradiol (Estrace®) hormone therapy.

Who is this for?

Postmenopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) breast cancer who have received at least 1 line of hormone therapy for advanced disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol (Estrace®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol (Estrace®) is type of hormone therapy for advanced ER+ breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05716516' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/estrace.html#:~:text=Estrace%20is%20used%20to%20treat,natural%20estrogen%20in%20the%20body.' target='_blank'>Drugs.com: Estradiol (Estrace®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

106

NEAREST SITE: 2693 miles
Dana Farber Cancer Institite
Boston,MA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05608252

VS-6766 Targeted Therapy for Advanced HR+, HER2- Breast Cancer

A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of VS-6766, an experimental RAF/MEK inhibitor, with abemaciclib (Verzenio®) CDK 4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received treatment with fulvestrant (Faslodex)® for advanced/metastatic disease and a CDK 4/6 inhibitor after surgery (adjuvant) or for advanced/metastatic disease. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766 is an experimental targeted therapy called a RAF/MEK inhibitor that targets and interrupts a pathway that allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05608252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verastem.com/research/pipeline/#raf-mek-inhibition' target='_blank'>Verastem: VS-6766 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

107

NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA

VISITS: Every 2-3 months, up to 5 years

PHASE: II

NCT ID: NCT07222215

Capecitabine and Elacestrant Versus Capecitabine Alone for ER+, HER2- Advanced Breast Cancer

A Phase II Multi-Center Open-label Randomized Study of CAPecitabine in Combination With ELAcestrant Versus Capecitabine Alone in Advanced Estrogen Receptor-Positive Breast Cancer (CAPELA) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of capecitabine (Xeloda®) chemotherapy and elacestrant (Orserdu®) oral SERD versus capecitabine alone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer whose cancer has progressed while receiving 1 or 2 lines of hormone therapy and palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for at least 6 months. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li> <li class="seamTextUnorderedListItem">CT scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">Electrocardiogram (ECG)</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">CT scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2-3 months</li> <li class="seamTextUnorderedListItem">Electrocardiogram (ECG)</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a SERD received by mouth and is approved for people with MBC and a mutation in the ESR1 gene. SERDs work by binding to and breaking down estrogen receptors. </li> <li class="seamTextUnorderedListItem">Participants in Group 2 with an ESR1 mutation whose cancer progresses on capecitabine have the option to continue in the trial and switch to elacestrant alone.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07222215' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.orserdu.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=23351373547&gbraid=0AAAABCDZCD8fUYjQTaZGVMAaU054fkATE&gclid=Cj0KCQiA4eHLBhCzARIsAJ2NZoKvkcIyFtvHb8DzhEzgbV-3X9vBKzc4Pg_8LyeSkBJe9XXQbH2DowAaAqHTEALw_wcB' target='_blank'>Menarini: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/new-hormone-therapies/' target='_blank'>Metastatic Trial Talk: Oral SERDs and Hormone Therapy</a> </li></ul>

108

No Travel Required

VISITS: No visits required

PHASE: III

NCT ID: NCT05703178

Web-Based Coping Skills Training to Decrease Pain from Hormone Therapy

Web-based Pain Coping Skills Training to Improve Pain and Poor Adherence Caused by Aromatase Inhibitor-Associated Arthralgia In Breast Cancer Survivors (SKIP-Arthralgia): A Randomized Controlled Trial Scientific Title

Purpose

To study if an online pain coping skills training program reduces the severity and effects of pain from treatment with aromatase inhibitors.

Who is this for?

Postmenopausal women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who have completed treatment. You must be taking an aromatase inhibitor and experience pain in your joints, bones, and/or muscles. Full eligibility criteria

Contact research site

Share with my doctor

Share with my patient

Contact Research Sites

What's involved?
What's being studied?
How can I learn more?

You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Online pain coping skills training program, weekly for 2-3 months</li> <li class="seamTextUnorderedListItem">Educational booklet about aromatase inhibitors and side effects</li> <li class="seamTextUnorderedListItem">Electronic pill bottle to track use of aromatase inhibitor medication</li> <li class="seamTextUnorderedListItem">Continue usual care</li> </ul> Group 2: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Educational booklet about aromatase inhibitors and side effects</li> <li class="seamTextUnorderedListItem">Electronic pill bottle to track use of aromatase inhibitor medication</li> <li class="seamTextUnorderedListItem">Continue usual care</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires, 4 times within 9-10 months</li> <li class="seamTextUnorderedListItem">Virtual visits, 3 times within 1 month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that block some production of estrogen that helps cancer grow. Approved aromatase inhibitors include anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Arthralgia is pain in the joints, bones, and/or muscles and is a common side effect of aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">The online pain coping skills training is an interactive, web-based program that teaches cognitive and behavioral skills to reduce pain and pain-related interference with daily activities. The program includes 8 sessions that are 35-45 minutes each. You will complete about 1 session per week.</li> <li class="seamTextUnorderedListItem">If you do not have a device capable of accessing the program, you will be loaned a tablet computer for the study.</li> <li class="seamTextUnorderedListItem">Benefits of the online pain coping skills training may include reduced severity of pain, improvements in quality of life, and improved adherence to aromatase inhibitor medication. The training may also increase your confidence in managing your pain and reduce unhelpful thinking patterns about pain.</li> <li class="seamTextUnorderedListItem">The educational booklet contains information about aromatase inhibitors, side effects including arthralgia, methods for managing arthralgia, and tips for talking with doctors about arthralgia and other side effects.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05703178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.scholars.northwestern.edu/en/projects/web-based-pain-coping-skills-training-to-improve-pain-and-poor-ad' target='_blank'>Northwestern University: Pain Coping Skills Training</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/aromatase-inhibitors/side-effects/' target='_blank'>Susan G Komen: Side Effects of Aromatase Inhibitors</a> </li></ul>