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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: May 08, 2024)
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Treatment
Brain Mets
BRCA1/2 (inherited)
Chemotherapy
Hormone Therapy
Leptomeningeal Disease
Radiation Oncology
Surgery
Surgery: Reconstruction
Targeted Therapy: All
Targeted Therapy: ADC
Targeted Therapy: Anti-HER2 Therapy
Targeted Therapy: CDK Inhibitors
Targeted Therapy: PARP Inhibitors
Targeted Therapy: Tumor Mutations
Targeted Therapy: Other Targeted Therapy
Vaccines and Immunotherapy
Other Treatment
Non-Treatment
Activities
Complementary and Integrative Medicine
Decision Support
Diagnosing Breast Cancer
Genetics/Family History
Having Children
Healthy/High Risk
Imaging
Lymphedema
Managing Side Effects
No Travel Required
Predicting Response to Treatment
Preventing Breast Cancer
Preventing Recurrence
Support/Education
Surveys/Interviews/Registries
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AKT
ALK
AR
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)
RB
ROS1
TP53
Click here to view online studies and trials that do not require site visits
1
NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05252416
BLU-222 Targeted Therapy and Hormone Therapy for Advanced ER+, HER2- Breast Cancer
A Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of BLU-222 as a Single Agent and in Combination Therapy for Patients With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of BLU-222, an experimental targeted therapy, with 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-) breast cancer that progressed after treatment with a CDK 4/6 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLU-222, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BLU-222 is an experimental targeted therapy called a CDK 2 inhibitor. It may block an enzyme, CDK 2, 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">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05252416' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.blueprintmedicines.com/pipeline/' target='_blank'>Blueprint Medicines Corporation: BLU-222 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>
2
NEAREST SITE: 3 miles
University of California, San Francisco
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
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
3
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
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
4
NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05514054
Imlunestrant Hormone Therapy for Stage I-III ER+, HER2- Breast Cancer
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of imlunestrant, an experimental hormone therapy, compared to standard hormone therapy.
Who is this for?
People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received 2-5 years of hormone therapy after surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356) 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">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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05514054' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Oral SERDs for Estrogen Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.loxooncology.com/pipeline/ly3484356' target='_blank'>Eli Lilly Drug Information Page: Imlunestrant (LY3484356)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>
5
NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA
VISITS: 1 visit every 3 months for 1.5 years
PHASE: NA
NCT ID: NCT05568472
Monitoring Symptoms to Help Women Continue Taking Hormone Therapy for Stage I-III Breast Cancer
A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN) Scientific Title
Purpose
To study if reporting symptoms by email, text, or phone helps women continue taking hormone therapy.
Who is this for?
Premenopausal or perimenopausal women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+) breast cancer who are receiving or planning to receive hormone therapy. You must have received surgery within 2 weeks of beginning this trial.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Receive health education materials</li> <li class="seamTextUnorderedListItem">Attend clinic visits, every 3 months for 1.5 years</li> <li class="seamTextUnorderedListItem">Report symptoms, by email, text, or phone, weekly for 6 months, then monthly for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Receive standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Receive health education materials</li> <li class="seamTextUnorderedListItem">Attend clinic visits, every 3 months for 1.5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy is a common treatment for hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Hormone therapy can cause side effects which may cause some women to stop treatment early. Asking about symptoms may help women continue taking hormone therapy.</li> <li class="seamTextUnorderedListItem">Health education materials contain information about breast cancer, side effects of breast cancer medicines, and ways to help with heart health.</li> <li class="seamTextUnorderedListItem">Questionnaires can be completed in English or Spanish.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05568472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/20070906b' target='_blank'>Breastcancer.org: Side Effects of Hormone Therapy</a> </li></ul>
6
NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA
VISITS: 1 visit every month
PHASE: I-II
NCT ID: NCT05548127
ARV-471 Hormone Therapy with Abemaciclib for Advanced ER+, HER2- Breast Cancer
TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-S... Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with abemaciclib (Verzenio®) CDK 4/6 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 have received treatment with a CDK 4/6 inhibitor and up to 2 lines of therapy for advanced/metastatic disease.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05548127' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 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></ul>
7
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
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on your situation: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <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>
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<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>
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<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>
8
NEAREST SITE: 3 miles
University of California San Francisco
San Francisco,CA
VISITS: 2 visits
PHASE: II
NCT ID: NCT04821141
Bazedoxifene and Estrogen Hormone Therapy to Reduce Risk Factors for Developing Breast Cancer
Randomized IIB Study of the Effect of Bazedoxifene Plus Conjugated Estrogens on Breast Imaging and Tissue Biomarkers in Peri or Post-Menopausal Women at Increased Risk for Development of Breast Cancer Scientific Title
Purpose
To study whether bazedoxifene and estrogen affect risk factors associated with developing breast cancer.
Who is this for?
Perimenopausal and postmenopausal women ages 45 to 60 who experience hot flashes and/or night sweats at least once a week and have a moderate risk of developing breast cancer. Risk factors include a family history of breast cancer, prior breast biopsies, or one of the following gene mutations: ATM, CDH1, CHEK2, NBN, NF1, PALB2, PTEN, STK11, P53, PTEN. You must not have a BRCA1/2 mutation.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bazedoxifene, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Estrogen, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Mammogram, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Fine needle aspiration biopsy, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mammogram, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Fine needle aspiration biopsy, 2 times within 6 months</li> <li class="seamTextUnorderedListItem">Blood tests, 2 times within 6 months</li> </ul> <p class="seamTextPara"> followed 6 months later by (optional): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bazedoxifene, by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Estrogen, by mouth, daily for 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bazedoxifene is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. It may help reduce the risk of breast cancer.</li> <li class="seamTextUnorderedListItem">Estrogen is a hormone used to treat women experiencing hot flashes.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04821141' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2022-03864&r=1#:~:text=Giving%20bazedoxifene%20with%20conjugated%20estrogens,increased%20risk%20for%20breast%20cancer.' target='_blank'>National Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a614004.html' target='_blank'>Medline Plus: Bazedoxifene and Estrogen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cdc.gov/cancer/breast/basic_info/mammograms.htm' target='_blank'>Centers for Disease Control and Prevention: Mammogram</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/screening-tests-and-early-detection/breast-biopsy/fine-needle-aspiration-biopsy-of-the-breast.html#:~:text=During%20a%20fine%20needle%20aspiration,needle%20biopsy%20is%20often%20preferred).' target='_blank'>American Cancer Society: Fine Needle Aspiration Biopsy</a> </li></ul>
9
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <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>
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<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>
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<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>
10
NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I
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
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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>
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<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>
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<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>
11
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
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<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>
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<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>
12
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
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<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
13
NEAREST SITE: 3 miles
UCSF
San Francisco,CA
VISITS: 1 visit every 6 months for 5 years
PHASE: II
NCT ID: NCT06075953
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 treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <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> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery (if needed)</li> </ul> <p class="seamTextPara"> or: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue on hormone therapy for 2-5 years</li> <li class="seamTextUnorderedListItem">Alternating MRI scan or mammogram every 6 months</li></ul>
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<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>
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<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/portfolio/dcis' 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>
14
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily, ongoing</li></ul>
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<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>
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<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>
15
NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA
VISITS: 1 visit every month
PHASE: I-II
NCT ID: NCT05573555
ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer
TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-S... Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with ribociclib (Kisqali®) CDK 4/6 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 have received treatment with a CDK 4/6 inhibitor and up to 2 lines of therapy for advanced/metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05573555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li></ul>
16
NEAREST SITE: 3 miles
UCSF
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05307705
LOXO-783 Targeted Therapy for Advanced Breast Cancer with a PIK3CA Mutation
A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of LOXO-783, an experimental targeted therapy called a PI3Kα inhibitor, alone or with hormone therapy, targeted therapy, and/or chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) cancer (including breast cancer) with a PIK3CA mutation who have received up to 5 lines of treatment. If your cancer is estrogen receptor positive (ER+), you must be postmenopausal.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 6 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: LOXO-783 Alone at Different Doses</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: LOXO-783 with Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection or imlunestrant, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: LOXO-783 with Targeted Therapy and Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Physician's choice of aromatase inhibitor, by mouth or fulvestrant (Faslodex®), by injection or imlunestrant, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: LOXO-783 with Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5: LOXO-783 with Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6: LOXO-783 Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783 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. LOXO-783 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and imlunestrant are hormone therapies called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is approved, and imlunestrant is experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive anastrozole (Arimidex®), exemestane (Aromasin®), or letrozole (Femara®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are hormone therapies that block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05307705' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.loxooncology.com/pipeline' target='_blank'>Loxo Oncology/ Eli Lilly Drug Information Page: LOXO-783 and Imlunestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://finance.yahoo.com/news/loxo-oncology-lilly-announces-details-130000189.html' target='_blank'>Eli Lilly Press Release: LOXO-783</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.newswire.ca/news-releases/lilly-announces-new-clinical-data-from-verzenio-and-oral-serd-programs-at-the-american-society-of-clinical-oncology-annual-meeting-859069920.html' target='_blank'>Eli Lilly Press Release: Imlunestrant</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/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>
17
NEAREST SITE: 8 miles
Epic Care Partners in Cancer Care
Emeryville,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05554354
Fulvestrant Alone or With Binimetinib Targeted Therapy for Metastatic HR+, HER2- Breast Cancer with a NF1 Mutation
A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1 Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy alone or with binimetinib (Mektovi®) MEK inhibitor.
Who is this for?
People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a NF1 mutation who have received treatment with a CDK 4/6 inhibitor. You must not have received more than 1 line of chemotherapy for metastatic disease.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT, MRI, or bone scan, 2 times</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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, which may inhibit the growth of estrogen-sensitive tumor cells.</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is a type of targeted therapy called a MEK inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">Targets or mutations: NF1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05554354' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618041.html' target='_blank'>Medline Plus: Binimetinib (Mektovi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
18
NEAREST SITE: 10 miles
Alta Bates Summit Medical Center; Comprehensive Cancer Center
Berkeley,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05306340
Hormone Therapy and Targeted Therapy for ER+, HER2- Advanced Breast Cancer
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With Exemestane Plus Everolimus in Patients With Estrogen Receptor-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 giredestrant, an experimental hormone therapy, with targeted therapy compared to an aromatase inhibitor with targeted 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 treatment with hormone therapy in combination with a CDK 4/6 inhibitor. You must not have received more than 2 lines of hormone therapy for advanced disease.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash, 4 times daily for at least 8 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash, 4 times daily for at least 8 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <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">Exemestane (Aromasin®) 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">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">Dexamethasone mouthwash is an anti-inflammatory medication used to prevent and treat side effects of some cancer drugs.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05306340' 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</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><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/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li></ul>
19
NEAREST SITE: 15 miles
Research Site
Greenbrae,CA
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
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant, by mouth, for 5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), anastrozole (Arimidex®), or tamoxifen (Nolvadex®), by mouth, for 5 years</li></ul>
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<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>
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<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>
20
NEAREST SITE: 15 miles
Marin Cancer Care Inc
Greenbrae,CA
VISITS: 2 visits for 1 month, then 1 visit every month
PHASE: III
NCT ID: NCT05646862
Targeted Therapy with Fulvestrant for HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation
A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combinatio... Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with fulvestrant (Faslodex®) hormone therapy compared to alpelisib (Piqray®) PI3K inhibitor 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. You must have received treatment with a CDK 4/6 inhibitor with hormone therapy as 1 of up to 2 lines of therapy for advanced/metastatic disease.
Full eligibility criteria
Contact research site
Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), every 2 weeks for 1 month, then monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">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">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05646862' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib</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/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
21
NEAREST SITE: 15 miles
Marin Cancer Care, Inc
Greenbrae,CA
VISITS: 1 visit every 3 months, for 13 months
PHASE: III
NCT ID: NCT04906395
Experimental Ovarian Suppression Therapy Every 3 Months for Premenopausal Women and Men with Stage I-III Hormone-Positive Breast Cancer
Phase 3,Single Arm,Open-Label Study Evaluating Ovarian Suppression Following 3 Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination With Endocrine Therapy in Premenopausal Subjects With Hormone-Receptor-Positive (HR+),Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Scientific Title
Purpose
To study the safety and effectiveness of an experimental ovarian suppression drug that is given every 3 months.
Who is this for?
People aged 18 to 55 with stage I, stage II, or stage III hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer who have not yet started anti-hormone therapy. If you are a woman, you must be premenopausal to enroll.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide acetate, by injection, every 3 months, for 1 year</li> <li class="seamTextUnorderedListItem">Your doctor's choice of tamoxifen or an aromatase inhibitor, by mouth, daily, for 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leuprolide acetate is a type of hormone therapy called a <q>luteinizing hormone-releasing hormone</q> (LHRH) agonist. It is approved for use in people with prostate cancer, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Leuprolide acetate is being used in this trial to suppress ovarian function (induce menopause) in women who are premenopausal.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04906395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/guidelines-on-ovary-suppression-for-early-HR-pos' target='_blank'>Breastcancer.org: ASCO Updates Guidelines on Ovarian Suppression</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/10.1200/JCO.2006.07.2397' target='_blank'>Journal Article: Leuprolide Acetate Plus Aromatase Inhibition for Male Breast Cancer</a> </li></ul>
22
NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,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
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
23
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth </li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li></ul>
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<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>
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<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>
24
NEAREST SITE: 28 miles
Kaiser Permanente - Vallejo
Vallejo,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT04961996
Adjuvant Therapy with Giredestrant for Stage I, II, or III Estrogen Receptor-Positive, HER2-Negative Breast Cancer
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, after surgery (adjuvant therapy).
Who is this for?
People with stage I, stage II, or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who are planning to receive hormone therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily for 5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of aromatase inhibitor or tamoxifen, by mouth, daily for 5 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adjuvant therapy is treatment given after surgery for stage I, stage II, or stage III breast cancer to prevent cancer from returning.</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">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">Tamoxifen (Nolvadex®) is commonly used to treat hormone-sensitive breast cancer.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04961996' 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</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/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>
25
NEAREST SITE: 28 miles
Stanford University
Stanford,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05101564
Biomarker Testing to Select Treatment for People with Stage I-III ER+, HER2- Breast Cancer
An Umbrella, Randomized, Controlled, Pre-Operative Trial Testing Integrative Subtype-Targeted Therapeutics in Hormone Receptor-Positive, HER2-Negative Breast Cancer Scientific Title
Purpose
To use biomarker testing to identify drugs that may slow tumor growth more than tamoxifen (Nolvadex®) or fulvestrant (Faslodex®) 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. You must not have received surgery, radiation, chemotherapy, or hormone therapy unless your breast cancer has come back (recurred).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups after biomarker testing: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily for 2-3 weeks</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 2-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 2-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zotatifin, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1 time</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1 time</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your tumor will be tested for levels of Ki-67.</li> <li class="seamTextUnorderedListItem">Ki-67 is a protein that is expressed in cancer cells. It increases as the cell prepares to divide into new cells.</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">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">Zotatifin is an experimental targeted therapy called a elF4A inhibitor. Blocking elF4A may block 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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05101564' target='_blank'>ClinicalTrials.gov</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/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/zotatifin-continues-to-demonstrate-favorable-activity-in-lung-and-breast-cancer-subtypes' target='_blank'>CancerNetwork: Zotatifin</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.curetoday.com/view/will-there-be-a-resurgence-of-ki-67-scoring-in-breast-cancer-' target='_blank'>CURE: Will There Be a Resurgence of Ki-67 Scoring in Breast Cancer?</a> </li></ul>
26
NEAREST SITE: 28 miles
Kaiser Permanente Medical Center - Vallejo
Vallejo,CA
VISITS: 1-3 visits per month
PHASE: III
NCT ID: NCT05501886
Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental pan-PI3K and mTOR inhibitor, with fulvestrant (Faslodex®) hormone therapy, with or without palbociclib (Ibrance®) 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 with or without a PIK3CA mutation who have received treatment with a CDK 4/6 inhibitor with an aromatase inhibitor. You must not have received more than 1 chemotherapy for advanced disease or 2 lines of hormone therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups depending on your cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental, with or without PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental, with or without PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care, without PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Standard of Care, with PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K and mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, 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">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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501886' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity Drug Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</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>
27
NEAREST SITE: 40 miles
Providence Queen of the Valley Medical Center
Napa,CA
VISITS: 1 visit every month
PHASE: III
NCT ID: NCT05654623
ARV-471 Hormone Therapy Compared to Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER TRIAL OF ARV-471 (PF-07850327) VS FULVESTRANT IN PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE BASED TREATMENT FOR ADVANCED DISEASE (VERITAC-2) Scientific Title
Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of ARV-471 (PF-07850327), an experimental hormone therapy, to 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-) breast cancer who have received 1 line of treatment with a CDK inhibitor with hormone therapy and up to 1 additional line of hormone therapy for advanced disease. You must not have received chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 (PF-07850327), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 (PF-07850327) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05654623' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='www.veritac2study.com' target='_blank'>Pfizer: Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas: ARV-471 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>
28
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
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Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <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>
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<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>
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<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>
29
NEAREST SITE: 317 miles
Asante Rogue Regional Medical Center
Medford,OR
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
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <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>
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<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>
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<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>
30
NEAREST SITE: 336 miles
UCLA Hematology/Oncology
Los Angeles,CA
VISITS: At least 1 visit per month
PHASE: I-II
NCT ID: NCT05262400
PF-07220060/PF-07104091 With Hormone Therapy for Advanced HR+, HER2- Breast Cancer
A PHASE 1B/2, OPEN-LABEL, MULTICENTER, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTITUMOR ACTIVITY OF PF-07220060 IN COMBINATION WITH PF-07104091 PLUS ENDOCRINE THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS Scientific Title
Purpose
To study the safety, best dose, side effects, and anti-cancer activity of PF-07220060/PF-07104091, a combination of experimental targeted therapies called CDK inhibitors, 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 on at least 1 line of therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060/PF-07104091, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060/PF-07104091, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a CDK 4 inhibitor.</li> <li class="seamTextUnorderedListItem">PF-07104091 is an experimental targeted therapy called a CDK 2 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 2 and 4 are proteins that help cancer grow. Blocking CDK 2 and 4 helps slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">PF-07220060/PF-07104091 is a combination of PF-07220060 and PF-07104091.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with 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 approved to treat hormone-positive breast cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05262400' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_04MAY2021.pdf?VersionId=.06Q_HtLdkBW8lme0Y3EXpraBpgGspyg' target='_blank'>Pfizer Drug Information Page: PF-07220060 and PF-07104091</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct05262400-breast-cancer-trial' target='_blank'>Pfizer Trial Information Page: PF-07220060 and PF-07104091</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/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li></ul>
31
NEAREST SITE: 336 miles
University of California at Los Angeles
Los Angeles,CA
VISITS: 1 visit
PHASE: NA
NCT ID: NCT04297020
Studying the Effects of Anti-Estrogen Therapy on the Brain of Women with Stage I-III Breast Cancer
Brain Health in Breast Cancer Survivors: Interaction of Menopause and Endocrine Therapy Scientific Title
Purpose
To see if anti-estrogen therapy affects brain health.
Who is this for?
Women between the ages of 35 and 65 who are currently taking anti-estrogen therapy for stage I, stage II, or stage III breast cancer and who did not receive chemotherapy. This trial is also enrolling women who have never been diagnosed with breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 Brain fMRI (functional MRI)</li> <li class="seamTextUnorderedListItem">Cognitive testing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial will use an advanced brain MRI technique called functional MRI (fMRI).</li> <li class="seamTextUnorderedListItem">fMRI measures changes in blood flow that happen during mental activity. </li> <li class="seamTextUnorderedListItem">Research suggests that the cognitive issues experienced by some women who receive treatment for breast cancer--also called <q>chemo brain</q>--may actually be caused by anti-estrogen therapy and not chemotherapy.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04297020' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/932091' target='_blank'>MedScape: In Breast Cancer, Is Chemobrain Really Endocrine Brain?</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Functional_magnetic_resonance_imaging' target='_blank'>Wikipedia: Functional MRI</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info.cfm?pg=fmribrain' target='_blank'>RadiologyInfo.org: fMRI</a> </li></ul>
32
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and recieve the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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>
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<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>
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<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>
33
NEAREST SITE: 341 miles
Cedars-Sinai Medical 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 an anti-hormone therapy after surgery, and your cancer must be considered at high risk for recurrence (coming back). See below for the definition of high-risk.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA blood test, every 4 to 6 months, for up to 7 years</li> </ul> <p class="seamTextPara"> If a ctDNA blood test is positive, you will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your current anti-hormone therapy (an aromatase inhibitor or tamoxifen)</li></ul>
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<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>
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<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>
34
NEAREST SITE: 342 miles
Clinical Trial Site
Los Angeles,CA
VISITS: Number of visits unavailable
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant (OP-1250)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy: fulvestrant (Faslodex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)</li></ul>
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<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>
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<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://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>
35
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®)</li> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
36
NEAREST SITE: 350 miles
OPN Healthcare
Arcadia,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05596409
Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer: An Open-Label Multicenter Phase 2 Study (ELCIN) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of elacestrant 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 1-2 lines of hormone therapy for advanced disease. You must not have received chemotherapy or a CDK4/6 inhibitor for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant 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">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05596409' 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://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>
37
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA
VISITS: Every 3 weeks, ongoing
PHASE: II
NCT ID: NCT02778685
Femara, Palbociclib, & Pembrolizumab for Metastatic ER Positive, HER2 Negative Breast Cancer
Phase II Study of the Addition of MK-3475 (Pembrolizumab) to Letrozole and Palbociclib in Patients With Metastatic Estrogen Receptor Positive Breast Cancer Who Have Stable Disease But Are Not Responding to Letrozole and Palbociclib Scientific Title
Purpose
To study the anti-cancer activity and effects (good and bad) of adding the immunotherapy drug pembrolizumab (Keytruda®) to the commonly used combination of the anti-estrogen drug letrozole (Femara®) and the CDK 4/6 inhibitor palbociclib (Ibrance®).
Who is this for?
Women with metastatic (stage IV) estrogen receptor positive (ER+) HER2 negative (HER2-) breast cancer who have not yet started treatment.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and palbociclib (Ibrance®) are an already approved therapy combination. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is an anti-estrogen therapy. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a CDK 4/6 inhibitor, which is a type of targeted therapy. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02778685' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com' target='_blank'>Pfizer Oncology Drug Information Page: Ibrance® (Palbociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwycfkBRAFEiwAnLX5IZ2WUInCzwQ56GHMYYq-KXijoX1dzOK1O8HBbmaxajT0CPi2CbX3sRoC3A4QA' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/the-evolving-field-of-erpositive-metastatic-breast-cancer-care' target='_blank'>Cure Today: The Evolving Field of ER Positive-Metastatic BC</a> </li></ul>
38
NEAREST SITE: 362 miles
Research Site
Long Beach,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT04964934
Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation
A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromata... Scientific Title
Purpose
To compare the safety and effects (good and bad) of camizestrant (AZD9833) and a CDK4/6 inhibitor with an aromatase inhibitor and a CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer and an ESR1 mutation. You must not have received treatment with fulvestrant (Faslodex®) or any investigational selective estrogen receptor degrader (SERD).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), 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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental type of anti-estrogen therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and abemaciclib (Verzenio®) are CDK4/6 inhibitors, a type of targeted therapy.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are aromatase inhibitors, a type of hormone therapy.</li> <li class="seamTextUnorderedListItem">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> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04964934' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Hormone Therapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/cdk4-6-inhibitors/' target='_blank'>Susan G. Komen: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/aromatase-inhibitors/' target='_blank'>Susan G. Komen: Aromatase Inhibitors</a> </li></ul>
39
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 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
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<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>
40
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
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
41
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
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
42
NEAREST SITE: 544 miles
Site 04
Vancouver,WA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT05654532
AC699 Hormone Therapy for Advanced ER+, HER2- Breast Cancer
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of AC699 in Patients With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Locally Advanced or Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of AC699, an experimental selective estrogen receptor degrader (SERD).
Who is this for?
Postmenopausal women and men 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. You must not have received more than 3 lines of chemotherapy for advanced/metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AC699, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AC699 is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05654532' target='_blank'>ClinicalTrials.gov</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>
43
NEAREST SITE: 595 miles
START Mountain Region
West Valley City,UT
VISITS: 1 visit every month
PHASE: I-II
NCT ID: NCT06206837
Vepdegestrant Hormone Therapy with PF-07220060 CDK4 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer
AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of vepdegestrant, an experimental hormone therapy, with PF-07220060, an experimental CDK4 inhibitor.
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 a CDK4/6 inhibitor and at least 1 line of therapy for advanced disease. You must not have received more than 2 lines of hormone therapy or 1 line of chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471), by mouth, daily</li> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06206837' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06206837-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_04MAY2021.pdf?VersionId=.06Q_HtLdkBW8lme0Y3EXpraBpgGspyg' target='_blank'>Pfizer: PF-07220060 Drug Information Page</a> </li></ul>
44
NEAREST SITE: 595 miles
START - Mountain Region
West Valley City,UT
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05251714
CFI-402257 Targeted Therapy with Hormone Therapy in Breast Cancer
A Dose-confirming Study of CFI-402257 as a Single Agent in Advanced Solid Tumors and in Combination With Fulvestrant in Patients With ER+/HER2- Advanced Breast Cancer After Disease Progression on Prior CDK4/6 and Endocrine Therapy Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of CFI-402257, an experimental targeted therapy, alone and with hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer that have received 1+ line of therapy. If your cancer is estrogen receptor positive (ER+), HER2 negative (HER2-), you must be have received treatment with 1-3 lines of hormone therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CFI-402257, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CFI-402257, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then weekly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CFI-402257 is an experimental targeted therapy called a TTF inhibitor. Blocking TTF may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men in Group 2 will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05251714' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://treadwelltx.com/pipeline/' target='_blank'>Treadwell Therapeutics Drug Information Page: CFI-402257</a> </li><li class='seamTextUnorderedListItem'><a href='https://treadwelltx.com/science/' target='_blank'>Treadwell Therapeutics: TTK Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
45
NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT02694809
Duavee Hormone Therapy for Postmenopausal Women with DCIS
A Large-scale Multicenter Phase II Study Evaluating the Protective Effect of a Tissue Selective Estrogen Complex (TSEC) in Women With Newly Diagnosed Ductal Carcinoma in Situ Scientific Title
Purpose
To study the safety, effects (good and bad), and ability of a drug called conjugated estrogens/bazedoxifene (Duavee®) to reduce the risk of developing breast cancer.
Who is this for?
Postmenopausal women with newly diagnosed estrogen receptor positive (ER+) DCIS who are planning to receive surgery or have positive margins after surgery.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Conjugated estrogens/bazedoxifene (Duavee®), by mouth, daily for 1 month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for conjugated estrogens/bazedoxifene (Duavee®), by mouth, daily for 1 month</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Conjugated estrogens/bazedoxifene (Duavee®) is a FDA approved hormone therapy used to treat symptoms of menopause such as hot flashes in women that do not have breast cancer.</li> <li class="seamTextUnorderedListItem">Because conjugated estrogens/bazedoxifene (Duavee®) is not approved in women with DCIS, its use in this study is experimental. </li> <li class="seamTextUnorderedListItem">Margins are the area around where DCIS was removed during surgery. A positive margin means DCIS cells were found in the margin after surgery.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02694809' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/conjugated-estrogens-and-bazedoxifene-oral-route/description/drg-20061326' target='_blank'>Mayo Clinic: Conjugated Estrogens/Bazedoxifene (Duavee®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/ductal-carcinoma-in-situ' target='_blank'>Breastcancer.org: DCIS</a> </li></ul>
46
NEAREST SITE: 650 miles
Mayo Clinic Arizona
Phoenix,AZ
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
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Z-endoxifen, by mouth, daily for 1-7 months</li> </ul> <p class="seamTextPara"> followed by (optional, if low Ki-67 levels after 1 month): </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <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> <p class="seamTextPara"> followed by (optional, if low Ki-67 levels after 1 month): </p> <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>
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<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>
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<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>
47
NEAREST SITE: 657 miles
Honor Health Research Institute
Scottsdale,AZ
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05546268
MRT-2359 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer
A Phase 1/2 Study of Oral MRT-2359 in Patients With MYC-Driven and Other Selected Solid Tumors Including Lung Cancer and Diffuse B-Cell Lymphoma Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of MRT-2359, an experimental targeted therapy, 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 who have no standard treatment options available.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRT-2359, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRT-2359 is an experimental targeted therapy called a molecular glue degrader (MGD). Molecular glue degrader (MGD) 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">This trial is enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05546268' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.monterosatx.com/queen/' target='_blank'>Monte Rosa Therapeutics: MRT-2359 Drug Information Page</a> </li></ul>
48
NEAREST SITE: 681 miles
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Seattle,WA
VISITS: 1-2 visits every month
PHASE: I-II
NCT ID: NCT05963997
Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations
A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy with samuraciclib, an experimental CDK7 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 TP53 and ESR1 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme that helps cancer grow.</li> <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">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53, ESR1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05963997' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li></ul>
49
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
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Poly ICLC, by injection, weekly for 2 weeks</li> </ul> <p class="seamTextPara"> followed 2 weeks later by: </p> <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> <p class="seamTextPara"> followed 6 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2-4 weeks</li></ul>
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<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>
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<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>
50
NEAREST SITE: 733 miles
Cancer Care Northwest
Spokane Valley,WA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT04791384
Elacestrant Hormone Therapy and Abemaciclib CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer with Brain or Leptomeningeal Metastasis
Multicenter Open Label Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- 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, with abemaciclib (Verzenio®) CDK 4/6 inhibitor.
Who is this for?
Postmenopausal women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who have received up to 2 chemotherapies for advanced/metastatic disease.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant, by mouth, daily</li></ul>
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<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 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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04791384' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</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>
51
NEAREST SITE: 752 miles
The University of Arizona Cancer Center
Tucson,AZ
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
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- What's being studied?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require a biopsy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<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>
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<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>
52
NEAREST SITE: 901 miles
St. Vincent Frontier Cancer Center
Billings,MT
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT06105632
PF-07220060 CDK4 Inhibitor with Fulvestrant Hormone Therapy for Advanced HR+, HER2- Breast Cancer
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS FULVESTRANT COMPARED TO INVESTIGATOR'S CHOICE OF THERAPY IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR CDK 4/6 INHIBITOR-BASED THERAPY Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of PF-07220060, an experimental CDK4 inhibitor, 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 who have received a CDK4/6 inhibitor with hormone therapy as the most recent line of therapy. You must not have received chemotherapy for advanced disease.
Full eligibility criteria
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- What's being studied?
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-
<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> or </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) and exemestane (Aromasin®), by mouth, daily</li></ul>
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<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">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">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">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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06105632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06105632-advanced-or-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_04MAY2021.pdf?VersionId=.06Q_HtLdkBW8lme0Y3EXpraBpgGspyg' target='_blank'>Pfizer: PF-07220060 Drug Information Page</a> </li></ul>
53
NEAREST SITE: 941 miles
University of Colorado Cancer Center
Aurora,CO
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05230810
Targeted Therapy for Metastatic HER2+ Breast Cancer with a PIK3CA Mutation
This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer. Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor and tucatinib (Tukysa) anti-HER2 targeted therapy with or without fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have received 2+ anti-HER2 targeted therapies.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection (for people with HR positive breast cancer)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <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">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells 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. You will only receive fulvestrant (Faslodex®) if you have HR+ (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women with HR+ breast cancer will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05230810' target='_blank'>ClinicalTrials.gov</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/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
54
NEAREST SITE: 945 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
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- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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>
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<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>
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<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>
55
NEAREST SITE: 946 miles
UCHealth - Medical Center of the Rockies
Loveland,CO
VISITS: 1 visit every month
PHASE: I-II
NCT ID: NCT06125522
Vepdegestrant Hormone Therapy with Samuraciclib CDK7 Inhibitor for Advanced ER+ or ER Low, HER2- Breast Cancer
TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 AND OLDER WITH ER+ ADVANCED OR METASTATIC BREAST CANC... Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of vepdegestrant (ARV-471), an experimental hormone therapy, with samuraciclib, an experimental CDK7 inhibitor.
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 up to 2 lines of therapy for advanced disease. You must have received a CDK4/6 inhibitor.
Full eligibility criteria
Contact research site
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- What's being studied?
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-
<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471), by mouth, daily</li> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vepdegestrant (ARV-471) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme that helps cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06125522' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li></ul>
56
NEAREST SITE: 1388 miles
Oklahoma University
Oklahoma City,OK
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
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- What's involved?
- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>
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<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>
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<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>
57
NEAREST SITE: 1418 miles
University of Nebraska Medical Center
Omaha,NE
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04762979
Alpelisib and Anti-Hormone Therapy for Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation
A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer Scientific Title
Purpose
To study the anti-cancer activity, safety, and side effects of giving the targeted therapy alpelisib (Piqray®) with an anti-hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that tests positive for a PIK3CA mutation. In addition, you must have already received a CDK 4/6 inhibitor, and you must not have received more than two anti-hormone therapies for metastatic disease.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Your doctor's choice of anti-hormone therapy, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04762979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lines-of-therapy-mbc/' target='_blank'>Metastatic Trial Talk: Lines of Therapy for MBC</a> </li></ul>
58
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
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- What's being studied?
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-
<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EP0062, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
59
NEAREST SITE: 1504 miles
Saint Luke's Cancer Institute
Kansas City,MO
VISITS: 1-2 visits every month
PHASE: II
NCT ID: NCT05963984
Samuraciclib CDK7 Inhibitor with Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 Mutations
An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy with or without samuraciclib, an experimental CDK7 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 TP53 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease.
Full eligibility criteria
Contact research site
Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times within 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times within 1 month, then monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme 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">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05963984' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib 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>
60
NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT02993159
Tamoxifen Delivered Through the Breast Skin to Control ER+ DCIS Before Surgery
Phase IIB Trial of Neoadjuvant Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women With DCIS of the Breast Scientific Title
Purpose
To compare the effect of tamoxifen (given orally) to an afimoxifene gel (applied to the breast before surgery) on the KI-67 protein.
Who is this for?
Women with ductal carcinoma in situ (DCIS) that is estrogen receptor positive (ER+). You must not have had surgery.
Full eligibility criteria
Contact research site
Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apply afimoxifene gel (TamoGel) to both breasts daily</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apply placebo gel to both breasts daily</li> <li class="seamTextUnorderedListItem">Tamoxifen citrate (Nolvadex ®), by mouth, daily, for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by surgery</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Ki-67 protein increases as the cell prepares to divide into new cells. Afimoxifene gel (TamoGel) is a gel that is applied to the skin to relieve breast pain. </li> <li class="seamTextUnorderedListItem">Tamoxifen citrate (Nolvadex ®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.</li> </ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02993159' 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></ul>
61
NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04570956
Tamoxifen Hormone Therapy for Women With Atypical Hyperplasia or LCIS
A Phase IIB Randomized Trial of Oral Tamoxifen vs. Topical 4-hydroxytamoxifen Gel vs. Control in Women With Atypical Hyperplasia or Lobular Carcinoma In Situ Scientific Title
Purpose
To study changes in breast tissue after treatment with tamoxifen by mouth or gel.
Who is this for?
Women with atypical hyperplasia or lobular carcinoma in situ (LCIS).
Full eligibility criteria
Contact research site
Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">4-hydroxytamoxifen (TamGel®), gel rubbed on the breast, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for tamoxifen (Nolvadex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Placebo for 4-hydroxytamoxifen (TamGel®), gel rubbed on the breast, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
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<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">4-hydroxytamoxifen (TamGel®) is a gel version of tamoxifen.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04570956' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/breast-cancer/in-depth/breast-cancer/art-20045353#:~:text=Tamoxifen%20is%20used%20to%20reduce,score%20is%20greater%20than%201.7%25.' target='_blank'>Mayo Clinic: Tamoxifen for Breast Cancer Prevention</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>
62
NEAREST SITE: 1626 miles
US Oncology
The Woodlands,TX
VISITS: 1 visit every month
PHASE: III
NCT ID: NCT04975308
Imlunestrant for Advanced ER+, HER2- Breast Cancer
EMBER-3: A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy Scientific Title
Purpose
To compare the effects (good and bad) and anti-cancer activity of imlunestrant, a selective estrogen receptor degrader (SERD), given alone or with abemaciclib (Verzenio®), to endocrine 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 experienced disease progression while taking an aromatase inhibitor.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Endocrine therapy (exemestane/Aromasin®, by mouth or fulvestrant/Faslodex®, by injection)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356), by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imlunestrant (LY3484356) is an experimental anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®) and fulvestrant (Faslodex®) are hormone therapies 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">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04975308' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Oral SERDs for Estrogen Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.newswire.ca/news-releases/lilly-announces-new-clinical-data-from-verzenio-and-oral-serd-programs-at-the-american-society-of-clinical-oncology-annual-meeting-859069920.html' target='_blank'>Eli Lilly Press Release: Imlunestrant (LY3484356)</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/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></ul>
63
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
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
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<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>
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<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>
64
NEAREST SITE: 1643 miles
Houston Methodist Cancer Center
Houston,TX
VISITS: 4 visits, over 6 months
PHASE: II
NCT ID: NCT01984138
Hormone Therapy or Lotion Inside the Vagina for Women with Stage I-III ER+ Breast Cancer Taking an Aromatase Inhibitor (Anti-Estrogen Therapy)
REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy Scientific Title
Purpose
To compare the safety and effects of using vaginal estrogen (Estring) or a vaginal moisturizer (Replens) to treat vaginal dryness, pain during intercourse, and other vaginal side effects of taking an aromatase inhibitor.
Who is this for?
Postmenopausal women with stage I, stage II, or stage III estrogen-receptor positive (ER+) breast cancer experiencing vaginal dryness, pain during intercourse, or 3 or more urinary tract infections a year since starting an aromatase inhibitor.
Full eligibility criteria
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-
<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estring vaginal ring, inserted into the vagina, every 3 months, for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2 </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Replens vaginal lotion, applied inside the vagina, 3 times a week, for 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of anti-estrogen therapy commonly used for stage I-IV hormone-positive (ER+ and/or PR+) breast cancer. </li> <li class="seamTextUnorderedListItem">The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">The side effects of taking an aromatase inhibitor may include vaginal dryness, vaginal itching, pain during intercourse, and urinary tract infections. </li> <li class="seamTextUnorderedListItem">Replens is a moisturizer that is applied inside the vagina. It does not contain any hormones.</li> <li class="seamTextUnorderedListItem">Estring is a ring that is placed inside the vagina and releases a low dose of estrogen.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01984138' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.houstonmethodist.org/1285_houstonmethodist/2847_ourresearch/2922_research_clinicaltrials/2923_research_searchclinicaltrials/clinicaltrialdetailnew/?Id=Pro00017710' target='_blank'>Houston Methodist Medical Center: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.estring.com/vaginal-atrophy-relief#estring' target='_blank'>Pfizer Drug Information Page: Estring (Vaginal Estrogen)</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.replens.com/Products/Replens-Long-Lasting-Moisturizer/FAQS.aspx' target='_blank'>Replens Drug Information Page: Replens (Vaginal Moisturizer)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/tips/menopausal/treat/vaginal-changes' target='_blank'>Breastcancer.org: Menopause Symptoms and Vaginal Changes</a> </li></ul>
65
NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX
VISITS: 1 visit every 3 weeks, over 1 year
PHASE: II
NCT ID: NCT04569747
Phesgo & Anti-Estrogen Therapy for Stage I HER2+, HR+ Breast Cancer
20-347 NCT Number Title A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer (ADEPT) Scientific Title
Purpose
To study the anti-cancer activity and side effects of giving a combination of anti-HER2 therapies by injection (instead of by IV) in combination with an anti-estrogen therapy.
Who is this for?
People with stage I node-negative, HER2 positive (HER2+), hormone positive (ER+ and/or PR+) breast cancer who have already had surgery.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) by injection, every 3 weeks, for one year</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, by mouth, daily, five years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo is a combination of two anti-HER2 therapies-- Perjeta® (pertuzumab) and Herceptin® (trastuzumab). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and trastuzumab are typically given by IV. With Phesgo, you can receive these therapies by injection, which shortens the length of time it takes to receive treatment. </li> <li class="seamTextUnorderedListItem">Phesgo is approved to treat early-stage and metastatic HER2+ breast cancer in combination with chemotherapy, but its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04569747' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.phesgo.com/about-phesgo/what-is-phesgo.html?c=phe-172a973f1cf&gclid=Cj0KCQiAjKqABhDLARIsABbJrGnxbgo39_l5XXQbx8yILiLlmUh9lCEU_oytPfswusesUSR_aVudTBMaAknqEALw_wcB&gclsrc=aw.ds' target='_blank'>Genentech Drug Information Page: Phesgo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Hormone Therapy for Breast Cancer</a> </li></ul>
66
NEAREST SITE: 1643 miles
The University of Texas MD Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable, ongoing
PHASE: I-II
NCT ID: NCT04557449
An Experimental CDK4 Inhibitor for Advanced Hormone Positive Breast Cancer
A PHASE 1/1B STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS Scientific Title
Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of the experimental targeted therapy PF-07220060.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+) breast cancer who have no standard of care therapies available.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental type of targeted therapy called a cyclin-dependent kinase (CDK) inhibitor. </li> <li class="seamTextUnorderedListItem">It blocks the CDK4 enzyme, which is a protein that helps cancers grow.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04557449' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/science/drug-product-pipeline' target='_blank'>Pfizer Oncology Drug Information Page: PF-07220060</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/CDK_inhibitor' target='_blank'>Wikipedia: CDK Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/answers/1947145-155365/what-is-the-role-of-hormone-therapy-in-the-treatment-of-metastatic-breast-cancer' target='_blank'>MedScape: What is the Role of Hormone Therapy in the Treatment of Metastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04557449' target='_blank'>Pfizer Trial Information Page: PF-07220060</a> </li></ul>
67
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
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
68
NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI
VISITS: 1 visit every 3 to 4 weeks, ongoing
PHASE: NA
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
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
69
NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint 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
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<p class="seamTextPara"> You will receive the following: </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oncotype DX test on tumor sample (biopsy)</li> <li class="seamTextUnorderedListItem">3 quality of life questionnaires</li></ul>
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<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>
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<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>
70
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
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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> <p class="seamTextPara"> followed 3 weeks later by: </p> <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>
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<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>
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<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>
71
NEAREST SITE: 1835 miles
Carle Cancer Center
Urbana,IL
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05207709
CDK4/6 Inhibitor with Hormone Therapy for Advanced HR+, HER2-, HER2 Enriched or Basal Like Breast Cancer
A Phase III, Multicenter, Open-label Study of Ribociclib vs. Palbociclib in Patients With Advanced Hormone Receptor-positive/HER2-negative/HER2-Enriched Breast Cancer - HARMONIA Trial Scientific Title
Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy with ribociclib (Kisqali®) or palbociclib (Ibrance®) CDK4/6 inhibitors.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), HER2 enriched or Basal like breast cancer. You must not have received treatment with chemotherapy for advanced disease or any CDK4/6 inhibitors.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HER2 Enriched Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 Enriched Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or fulvestrant (Faslodex®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Basal Like Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) with or without tislelizumab</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">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 production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Tislelizumab is an experimental 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">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">The PAM50 (Prosigna®) test will determine if you have HER2 enriched or Basal like breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05207709' target='_blank'>ClinicalTrials.gov</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><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/our-science-and-medicines/tislelizumab/' target='_blank'>Beigene: Tislelizumab Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/diagnosis/molecular-subtypes/' target='_blank'>Susan G. Komen: HER2-Enriched and Basal-Like Breast Cancer</a> </li></ul>
72
NEAREST SITE: 1853 miles
University of Illinois Cancer Center
Chicago,IL
VISITS: 2 visits over 5 weeks
PHASE: II
NCT ID: NCT04009044
Anti-Estrogen Gel on Breast Skin for Women Who Received Radiation Therapy
A Phase II Study of the Determinants of Transdermal Drug Delivery to the Normal and the Radiated Breast Scientific Title
Purpose
To study how different skin types and radiation therapy affect how afimoxifene is absorbed into the breast.
Who is this for?
Women who have received radiation therapy on one breast for DCIS or stage I, stage II or stage III breast cancer within the last five years.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Afimoxifene gel, placed on breast skin, once a day, for 4 weeks</li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 biopsy of each breast</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Afimoxifene is an anti-estrogen gel that can be put on the skin of the breast at home.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04009044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Afimoxifene' target='_blank'>Wikipedia: Afimoxifene</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/afimoxifene' target='_blank'>NCI Drug Dictionary: Afimoxifene</a> </li></ul>
73
NEAREST SITE: 1958 miles
Vanderbilt University/Ingram Cancer Center
Nashville,TN
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-), non-Luminal A breast cancer who have received treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator (SERM/SERD) with 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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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">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>
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<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>
74
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
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AND019, by mouth, daily</li></ul>
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<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>
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<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>
75
NEAREST SITE: 2037 miles
St. Elizabeth Healthcare
Edgewood,KY
VISITS: Weekly visits
PHASE: II
NCT ID: NCT02760030
Faslodex & Ibrance for People Age 70 & Older with Stage I-III Breast Cancer
Phase II Trial of Primary Endocrine Therapy With Combination of Fulvestrant and Palbociclib in Elderly Patients With Hormone Responsive Breast Cancer Who Have Inoperable Tumor Or Operable Tumor But Cannot Undergo Surgery Due to Frailty Or Who Refuse Surgery Scientific Title
Purpose
To study the effects (good and bad) of giving fulvestrant and palbociclib to older patients who will not have surgery.
Who is this for?
People, 70 or older, who were recently diagnosed with stage I, stage II or stage III breast cancer and elected to not have surgery. Your tumor must be hormone receptor positive (ER+ and/or PR+) and HER2 negative.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, weekly, 2 weeks on, 2 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some older people diagnosed with early-stage breast cancer do not have surgery.</li> <li class="seamTextUnorderedListItem">Two drugs now used to treat breast cancer that has spread to other parts of the body may be a good treatment option for these patients.</li> <li class="seamTextUnorderedListItem">The drugs are called fulvestrant (Faslodex®) and palbociclib (Ibrance®).</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is an anti-estrogen therapy used to treat metastatic hormone positive tumors in postmenopausal women.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a targeted therapy. It keeps cancer cells from growing by blocking two enzymes, CDK4 and CDK6.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02760030' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://malebreastcancercoalition.org' target='_blank'>Male Breast Cancer Coalition</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/erds/faslodex' target='_blank'>Breastcancer.org: Faslodex</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Palbociclib' target='_blank'>Wikipedia: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com' target='_blank'>Pfizer Oncology Information Page: Ibrance</a> </li></ul>
76
NEAREST SITE: 2054 miles
University of Michigan
Ann Arbor,MI
VISITS: 3 visits every month
PHASE: III
NCT ID: NCT05909397
ARV-471 Hormone Therapy with CDK 4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer
A PHASE 3, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY OF ARV-471(PF-07850327) PLUS PALBOCICLIB VERSUS LETROZOLE PLUS PALBOCICLIB FOR THE TREATMENT OF PARTICIPANTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTI-CANCER TREATMENT FOR ADVANCED DISEASE (VERITAC-3) Scientific Title
Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of ARV-471, an experimental hormone therapy, and letrozole (Femara®) hormone therapy with palbociclib (Ibrance®) CDK 4/6 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 have not yet received treatment for advanced disease. You must not have received treatment with a CDK 4/6 inhibitor or fulvestrant (Faslodex®).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 (vepdegestrant, PF-07850327) is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05909397' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05909397-advanced-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/pipeline-programs/estrogen-receptor' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li></ul>
77
NEAREST SITE: 2054 miles
University of Michigan Rogel Cancer Center
Ann Arbor,MI
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT05700006
Effects of Hormone Therapy vs. No Hormone Therapy for Breast Cancer and Breast Cancer Prevention on Aging and the Microbiome
An Observational Study of Women With Breast Cancer Examining the Effect of Endocrine Therapy on Aging Scientific Title
Purpose
To study the effects of hormone therapy on biomarkers of aging and the microbiome.
Who is this for?
Women with stage 0 (DCIS), stage I, stage II, or stage III breast cancer or women at high risk of developing breast cancer. You must not have received treatment with an aromatase inhibitor for breast cancer or breast cancer prevention.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups depending on your situation: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Over 65 and Planning to Receive Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of anastrozole (Arimidex®), exemestane (Aromasin®), or letrozole (Femara®)</li> <li class="seamTextUnorderedListItem">3 stool samples, questionnaires, blood draws</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Over 65 and Not Planning to Receive Hormone Therapy (Control Group)</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 stool samples, questionnaires, blood draws</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Under 65 and Planning to Receive Hormone Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of anastrozole (Arimidex®), exemestane (Aromasin®), or letrozole (Femara®)</li> <li class="seamTextUnorderedListItem">3 stool samples, questionnaires, blood draws</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The microbiome is the collection of microorganisms (bacteria) living in your digestive tract.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), exemestane (Aromasin®), and letrozole (Femara®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05700006' target='_blank'>ClinicalTrials.gov</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/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</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.insideprecisionmedicine.com/topics/oncology/breast-cancer/probiotic-bacteria-may-improve-efficacy-of-endocrine-targeted-therapies-for-breast-cancer/' target='_blank'>Inside Precision Medicine: Breast Cancer Treatments and the Microbiome</a> </li></ul>
78
NEAREST SITE: 2055 miles
University of Kentucky Markey Cancer Center
Lexington,KY
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05150652
Hormone Therapy Before Surgery for ER+, HER2+, Stage I or II Breast Cancer
Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer Scientific Title
Purpose
To evaluate the effect of hormone therapy on tumor shrinkage when given before breast cancer surgery.
Who is this for?
Women with stage I or II estrogen receptor-positive (ER+), HER2 negative (HER-2-) breast cancer who are node-negative and have not had surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive one of the following hormone therapy drugs for 6 months before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"> Anastrozole (Arimidex®) by mouth, once daily</li> <li class="seamTextUnorderedListItem"> Letrozole (Femara®) by mouth once daily</li> <li class="seamTextUnorderedListItem"> Exemestane (Aromasin®) by mouth, once daily</li> <li class="seamTextUnorderedListItem"> Tamoxifen (Soltamox®) by mouth, once daily</li></ul>
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<ul class="seamTextUnorderedList"> <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">Anastrozole (Arimidex®), Letrozole (Femara®), and Exemestane (Aromasin®) are types of anti-estrogen therapies 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">Tamoxifen (Soltamox®) is a type of hormone therapy that blocks the effects of estrogen in breast tissue. It is commonly used to treat people with hormone-positive breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05150652' target='_blank'>ClinicalTrials.gov</a> </li></ul>
79
NEAREST SITE: 2135 miles
Emory Saint Joseph's Hospital
Atlanta,GA
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT05464810
Letrozole Hormone Therapy Alone or With Simvastatin 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.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 weeks</li></ul>
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<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>
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<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>
80
NEAREST SITE: 2139 miles
Emory Winship Cancer Institute
Atlanta,GA
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
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: CCNE1 Amplified Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: ER Positive, HER2 Negative Breast Cancer</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
81
NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05447910
Analysis of Letrozole in Patients With Operable Hormone Receptor Positive, HER2 Negative Breast Cancer
Comprehensive Single-Cell Transcriptional Analysis of Aromatase Inhibitor-Resistant Breast Cancer Scientific Title
Purpose
To study the effects (good and bad) of neoadjuvant (before surgery) letrozole (Femara®) on breast tumors.
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 treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2-8 weeks</li></ul>
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<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">Letrozole (Femara®) decreases the amount of estrogen produced by the body. This can slow or stop the growth of some types of breast cancer cells that need estrogen to grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) will be given before surgery (neoadjuvant).</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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05447910' 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></ul>
82
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
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
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
83
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Accelerated partial breast irradiation, 5 times within 10 days</li></ul>
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<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>
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<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>
84
NEAREST SITE: 2425 miles
NEXT Oncology Virginia
Fairfax,VA
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
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HR positive, HER2 negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li></ul>
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<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>
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<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>
85
NEAREST SITE: 2536 miles
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie,FL
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
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy</li></ul>
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<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>
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<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>
86
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
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<p class="seamTextPara"> You will receive the following: </p> <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>
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<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>
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<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>
87
NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge,NJ
VISITS: 1-4 visits within 1 month
PHASE: II
NCT ID: NCT05966584
Benralizumab to Prevent Rashes During Treatment with Alpelisib for Metastatic ER+, HER2- Breast Cancer with PIK3CA Mutations
RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer Scientific Title
Purpose
To study the ability of benralizumab to prevent rashes during treatment with alpelisib (Piqray®) PI3K inhibitor and hormone therapy.
Who is this for?
Postmenopausal women and men with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with PIK3CA mutations who are planning to receive hormone therapy. You must not have received more than 2 lines of hormone therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Benralizumab, by injection, 1 time</li> </ul> <p class="seamTextPara"> with standard of care therapy: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), 3 times within 1 month, then monthly, or an aromatase inhibitor</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Skin rash is a common side effect of alpelisib (Piqray®).</li> <li class="seamTextUnorderedListItem">Researchers think adding benralizumab to standard of care therapy may prevent rashes.</li> <li class="seamTextUnorderedListItem">Benralizumab is an immunotherapy that is used to treat diseases such as asthma. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, alpelisib (Piqray®), fulvestrant (Faslodex®), and aromatase inhibitors are standard of care therapies.</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">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">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">Targets or mutations: PIK3CA</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05966584' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618002.html#:~:text=Benralizumab%20injection%20is%20used%20along,with%20their%20current%20asthma%20medication.' target='_blank'>MedlinePlus: Benralizumab</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/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>
88
NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ
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
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
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<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>
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<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>
89
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
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<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>
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<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>
90
NEAREST SITE: 2586 miles
Stamford Hospital
Stamford,CT
VISITS: 1 visit every 2-3 months for 2-5 years
PHASE: II
NCT ID: NCT06001762
Increasing the Dose of Abemaciclib to Reduce Side Effects for Stage II-III HR+, HER2-, Node Positive Breast Cancer
The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer Scientific Title
Purpose
To study if increasing the dose of abemaciclib (Verzenio®) CDK4/6 inhibitor over time will have fewer side effects than the standard dose schedule.
Who is this for?
People with stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), node positive breast cancer. You must have received surgery for your breast cancer within the last 1 year and 4 months.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">At least one of the following: Tamoxifen (Nolvadex®), anastrozole (Arimidex®), letrozole (Femara®), exemestane (Aromasin®), LHRH agonist</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <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">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">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">LHRH agonists stop the ovaries from making estrogen, called ovarian suppression. This prevents the tumor from receiving estrogen it needs to grow.</li> <li class="seamTextUnorderedListItem">Node positive means cancer has been found in your lymph nodes.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06001762' target='_blank'>ClinicalTrials.gov</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.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/types/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html#:~:text=Luteinizing%20hormone%2Dreleasing%20hormone%20(LHRH,)%20and%20leuprolide%20(Lupron).' target='_blank'>American Cancer Society: LHRH Agonists</a> </li></ul>
91
NEAREST SITE: 2591 miles
University of Miami
Miami,FL
VISITS: At least 1 visit every 2 months
PHASE: II
NCT ID: NCT05826964
ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study Scientific Title
Purpose
To determine whether switching treatment earlier will increase the amount of time that metastatic breast cancer is controlled.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Early Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early switch to a new treatment, for 1 year 2 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used to indicate tumor biomarkers and the presence of circulating tumor (ctDNA).</li> <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">In this trial, HER2 low is define as IHC 1+ or 2+/FISH-.</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">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">Palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) 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">If you are premenopausal, you must also take a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05826964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>
92
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
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on biomarker testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <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>
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<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>
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<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>
93
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
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol (Estrace®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol (Estrace®) is type of hormone therapy for advanced ER+ breast cancer.</li></ul>
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<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>
94
NEAREST SITE: 2693 miles
Beth Israel Deaconess Medical Center
Boston,MA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT03285412
Additional Therapy after Standard Treatment for Women with Stage I-III, ER+, HER2- Breast Cancer with Residual Disease by ctDNA Testing
Phase II Study of CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER) Scientific Title
Purpose
To study the anti-cancer activity, safety, and side effects of giving additional treatment with a CDK 4/6 inhibitor to treat residual disease defined as testing positive for ctDNA.
Who is this for?
Women with stage I, stage II, or stage III estrogen receptor-positive (ER+), HER2 negative (HER2-) breast cancer who have completed treatment (other than hormone therapy) for breast cancer and test positive for detectable disease with a ctDNA test. You will be given a blood test to look for ctDNA. You may enroll in this trial up to ten years after diagnosis.
Full eligibility criteria
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<p class="seamTextPara"> If your ctDNA test comes back positive for residual disease, you will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li></ul>
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<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 women'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 women with a positive ctDNA test additional treatment.</li> <li class="seamTextUnorderedListItem">The additional treatment in this trial includes Ribociclib (Kisqali®).</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03285412' target='_blank'>ClinicalTrials.gov</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://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://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>
95
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
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- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
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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
- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <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>
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<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>
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<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>
