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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: June 10, 2026)

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Treatment

Brain Mets

BRCA1/2 (inherited)

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Hormone Therapy

Leptomeningeal Disease

Radiation Oncology

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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

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AKT

ALK

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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

1

NEAREST SITE: 3 miles
California Pacific Medical Center Research Institute
San Francisco,CA

VISITS: Coincides with targeted therapy

PHASE: II

NCT ID: NCT02693535

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a genomic or immunohistochemistry test approved by TAPUR.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>
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2

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05563220' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li></ul>
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3

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT07100106

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of GDC-4198 CDK2/4/6 inhibitor and giredestrant oral SERD compared with abemaciclib (Verzenio®) CDK4/6 inhibitor and giredestrant.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have experienced disease progression during or after receiving a CDK4/6 inhibitor and hormone therapy. You must not have received more than 1 line of therapy or chemotherapy.    Full eligibility criteria
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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">GDC-4198, by mouth, daily, up to 3 years</li> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, up to 3 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, up to 3 years</li> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, up to 3 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-4198 is an experimental CDK2/4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07100106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://regor.com/#pipeline' target='_blank'>Regor Therapeutics: GDC-4198</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/giredestrant' target='_blank'>Genentech: Giredestrant</a> </li></ul>
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4

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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  • 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 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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>
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5

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

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Faslodex is given by injection. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is also a CDK 4/6 inhibitor. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an experimental type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT. </li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental type of targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Inavolisib may slow or stop cancer cells from growing by blocking this pathway. </li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04802759' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant (GDC-9545)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors (Abemaciclib & Ribociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib (AKT Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/everolimus.aspx' target='_blank'>Chemocare: Everolimus (Afinitor)</a> </li></ul>
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7

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06790693

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of inavolisib (Itovebi®) PI3K inhibitor with palbociclib (Ibrance®) CDK4/6 inhibitor and letrozole (Femara®) aromatase inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation. You must have been diagnosed with de novo advanced/metastatic breast cancer or received at least 2 years of hormone therapy and completed hormone therapy at least 1 year before your advanced/metastatic diagnosis. You must have not yet received treatment for advanced disease.    Full eligibility criteria
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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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib (Itovebi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib (Itovebi®) is a type of targeted therapy called a PI3K inhibitor. It can stop cancer cell growth of tumors with a PIK3CA mutation.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06790693' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.itovebi.com/?c=ina-192c045e973&gad_source=1&gad_campaignid=22379686314&gclid=CjwKCAjw3_PCBhA2EiwAkH_j4vPWHwf18zpyVOBvHcRP6iHfngpGw_isqNXvAvPlr2i6vJ0TAA8mdxoCtHYQAvD_BwE&gclsrc=aw.ds' target='_blank'>Hoffman-La Roche: Inavolisib (Itovebi®)</a> </li></ul>
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8

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06065748

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, compared with fulvestrant (Faslodex®) hormone therapy in combination with a CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who not have received treatment (except for surgery or radiation) for advanced disease.    Full eligibility criteria
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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: 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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and giredestrant are a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental SERD.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">The FoundationOne Liquid CDx Assay blood test will identify ctDNA mutations.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06065748' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html#:~:text=This%20compound%20and%20its%20use,US%20Food%20and%20Drug%20Administration.' target='_blank'>Genentech: Giredestrant Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>
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9

NEAREST SITE: 15 miles
Marin Cancer Care
Greenbrae,CA

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

PHASE: III

NCT ID: NCT07174336

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

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

Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of Tersolisib (LY4064809), an experimental PI3Ka inhibitor, with standard of care CDK4/6 inhibitor and hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer with a PIK3CA mutation. You may have received 0-2 prior treatments for advanced or metastatic breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1: For people who have received prior treatment:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809), by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2: For people who have not yet received treatment, you will be randomly assigned to 1 of 2 groups:</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809), by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, once or twice a day</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor determined by your physician, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy determined by your physician, by mouth or injection</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tersolisib (LY4064809) is an experimental type of targeted therapy called a PI3K inhibitor. </li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Tersolisib may slow or stop cancer cells from growing by blocking this pathway.</li> <li class="seamTextUnorderedListItem">Standard of care treatment for hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer is treatment with hormone therapy along with a CDK inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07174336' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-biomarkers-part-1/' target='_blank'>Metastatic Trial Talk: Biomarkers to Guide MBC Treatment Decisions: PIK3CA, BRCA1/BRCA2, and PD-L1/PD-1</a> </li></ul>
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10

NEAREST SITE: 15 miles
Marin Cancer Care
Greenbrae,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06997029

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of BMS-986500, a CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986500</li> <li class="seamTextUnorderedListItem">Palbociblib (Ibrance®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BMS-986500 is a CDK4/6 inhibitor. </li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06997029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK4/6 Inhibitors</a> </li></ul>
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11

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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  • 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: 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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05952557' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.goodrx.com/conditions/breast-cancer/oral-serd' target='_blank'>GoodRX: What is a SERD?</a> </li></ul>
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12

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07114601

LY4257496 GRPR Radiopharmaceutical for Advanced ER+ Breast Cancer

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of LY4257496 GRPR radiopharmaceutical with or without standard of care therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) breast cancer. Your tumor must be positive for gastrin-releasing peptide receptor (GRPR).    Full eligibility criteria
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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">LY4257496, by IV, up to 9 months</li> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4257496, by IV, up to 9 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY4257496 is a radiopharmaceutical that targets GRPR. A radiopharmaceutical is a type of therapy that combines a molecule that targets cancer cells with a radioactive molecule that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Gastrin Releasing Peptide Receptor (GRPR) is a G protein coupled receptor activated by the peptide gastrin-releasing peptide (GRP), which regulates various bodily functions, including gastrointestinal activity and central nervous system processes. GRPR plays a role in normal functions like hormone release and smooth muscle contraction.</li> <li class="seamTextUnorderedListItem">Standard of care options in this trial are fulvestrant (Faslodex®), imlunestrant (Inluriyo®), capecitabine (Xeloda®), abemaciclib (Verzenio®) and aromatase inhibitors- letrozole (Femara®), anastrozole (Arimidex®), and exemestane (Aromasin®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07114601' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/mbc-radiopharmaceuticals/' target='_blank'>Metastatic Trial Talk: Radiopharmaceuticals</a> </li></ul>
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13

NEAREST SITE: 28 miles
Stanford Cancer Institute Palo Alto
Palo Alto,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 involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>
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14

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05827081

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

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

Purpose
To study if ribociclib (Kisqali®) CDK4/6 inhibitor with hormone therapy increases the amount of time before breast cancer comes back.
Who is this for?
People with some stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose surgical margins do not have cancer. You must have begun hormone therapy in the last 3 years and be planning to receive hormone therapy for at least 3 more years.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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">Standard of care hormone therapy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are postmenopausal, hormone therapy consists of letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">If you are premenopausal or male, hormone therapy consists of letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®) plus goserelin (Zoladex®) or leuprolide (Lupron Depot®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05827081' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>
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15

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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  • 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: 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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. It blocks two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05696626' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://sermonixpharma.com/lasofoxifene/' target='_blank'>Sermonix Pharmaceuticals: Lasofoxifene Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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16

NEAREST SITE: 336 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06380751

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

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

Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of saruparib, an experimental PARP1 inhibitor, with camizestrant, an experimental hormone therapy, to standard of care CDK4/6 inhibitor with hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer with BRCA1, BRCA2, or PALB2 mutations.    Full eligibility criteria
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  • 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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305), by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Saruparib (AZD5305) is an experimental targeted therapy called a PARP1 inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06380751' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D9722C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/next-generation-parp-inhibitor-demonstrates-clinical-benefit-in-patients-with-homologous-recombination-repair-deficient-breast-cancer/' target='_blank'>AACR: Saruparib for Homologous Recombination Repair Deficient Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>AACR: Camizestrant for Hormone Receptor Positive, HER2 Negative Breast Cancer</a> </li></ul>
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17

NEAREST SITE: 336 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable, up to 2 years

PHASE: I-II

NCT ID: NCT05985655

GTAEXS617 for Advanced HR+ HER2- Breast Cancer

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of GTAEXS617-001 CDK7 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed while receiving palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®).    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">GTAEXS617, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GTAEXS617, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blocking CDK7 is expected to slow cancer cell growth.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05985655' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.exscientia.com/wp-content/uploads/2024/09/Exscientia_617_Sept24.pdf' target='_blank'>Exscientia: GTAEXS617</a> </li></ul>
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18

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

VISITS: At least 1 visit every month

PHASE: I-II

NCT ID: NCT06726148

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of ECI830, an experimental; CDK2 inhibitor, with ribociclib (Kisqali®) CDK4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor or tamoxifen (Nolvadex®) with a CDK4/6 inhibitor. You must not have received more than 2 lines of hormone therapy.    Full eligibility criteria
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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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ECI830 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block an enzyme, CDK2, that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®). are letrozole (Femara®), anastrozole (Arimidex®), and exemestane (Aromasin®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06726148' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/nct06726148' target='_blank'>Novartis: Trial Information Page</a> </li></ul>
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19

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

VISITS: Number of visits unavailable, up to 2 years

PHASE: I-II

NCT ID: NCT06998407

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of AVZO-023 CDK4 inhibitor in combination with hormone therapy and an experimental CDK2 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must not have received CDK2, 4, and/or 6 inhibitors. You must not have active, untreated brain metastases.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">AVZO-021, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023, by mouth</li> <li class="seamTextUnorderedListItem">AVZO-021, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).</li> <li class="seamTextUnorderedListItem">AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK2). CDK inhibitors block enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06998407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/#moa' target='_blank'>Avenzo Therapeutics: AVZO-023</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK4/6 Inhibitors</a> </li></ul>
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20

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05304962

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

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

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of RGT-419B, an experimental type of targeted therapy called a CDK 2/4/6 inhibitor, alone and with hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has progressed after treatment with a CDK 4/6 inhibitor and hormone therapy. You must not have received more than 1 line of chemotherapy.    Full eligibility criteria
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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 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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B is an experimental type of targeted therapy called a CDK 2/4/6 inhibitor. It is designed to block three enzymes, CDK2, CDK4, and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive one of the following types of hormone therapy that you have already received: selective estrogen receptor degrader (SERD), selective estrogen receptor modulator (SERM), or aromatase inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05304962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/regor-therapeutics-announces-u-s-fda-authorization-to-conduct-regor-s-first-in-human-clinical-trial-with-the-next-generation-targeted-inhibitor-rgt-419b-for-oncology/' target='_blank'>Regor Therapeutics Press Release: RGT-419B</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: CDK Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>
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21

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

VISITS: 1 visit every 1-2 weeks

PHASE: III

NCT ID: NCT06757634

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental targeted therapy, with standard of care CDK4/6 inhibitor and hormone therapy compared to standard of care alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who were diagnosed with advanced disease during or within 1 year of completing hormone therapy. You must have not yet received treatment for advanced disease.    Full eligibility criteria
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  • 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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K/mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are types of targeted therapies called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06757634' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/our-approach/viktoria-2-2/' target='_blank'>Celcuity: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity: Gedatolisib Drug Information Page</a> </li></ul>
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22

NEAREST SITE: 340 miles
Valkyrie Clinical Trials
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05238922

INCB123667 Targeted Therapy for Advanced Breast Cancer

A Phase 1, Open-Label, Multicenter Study of INCB123667 as Monotherapy in Participants With Selected Advanced Solid Tumors Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of INCB123667, an experimental type of targeted therapy called a CDK 2 inhibitor.
Who is this for?
For people with advanced (some stage III) or metastatic (stage IV) breast cancer that has progressed on standard treatment. If you have hormone receptor positive (ER+ and/or PR+) breast cancer, you must not have received 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">INCB0123667, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require at least 1 biopsy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB123667 is an experimental type of targeted therapy called a CDK 2/CDK2 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05238922' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.incyteclinicaltrials.com/study/?id=INCB%20123667-101' target='_blank'>Incyte Corporation Clinical Trial Page: INCB123667</a> </li><li class='seamTextUnorderedListItem'><a href='https://investor.incyte.com/news-releases/news-release-details/incyte-reports-2022-first-quarter-financial-results-and-provides' target='_blank'>Incyte Corporation Press Release: INCB123667</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: CDK 4/6 Inhibitors</a> </li></ul>
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23

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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  • 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">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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05386108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>
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24

NEAREST SITE: 343 miles
Keck Medicine of USC Koreatown
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05372640

ZEN003694 and Abemaciclib Targeted Therapies for Advanced Breast Cancer

A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ZEN003694, an experimental BET bromodomain Inhibitor, with abemaciclib (Verzenio®) CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have no standard treatment options available.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694, by mouth, daily, 5 days on, 2 days off</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694 is an experimental targeted therapy called a BET bromodomain inhibitor. It may prevent the growth of tumor cells that overproduce BET protein.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05372640' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zenithepigenetics.com/programs/pipeline' target='_blank'>Zenith Epigenetics Drug Information Page: ZEN-3694</a> </li></ul>
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25

NEAREST SITE: 347 miles
City of Hope South Pasadena
South Pasadena,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04305834

Effects of Abemaciclib in People 70 or Older With Metastatic Hormone Positive Breast Cancer

A Phase IIA Trial Assessing the Tolerability of Abemaciclib Monotherapy in Patients Age 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer Scientific Title

Purpose
To study the side effects (good and bad) of abemaciclib (Verzenio®).
Who is this for?
People with metastatic (stage IV), hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are age 70 or older and have already received treatment 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04305834' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com' target='_blank'>Drug Company Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/breast-cancer-elderly-how-bcrf-researchers-are-treating-growing-patient-population' target='_blank'>Breast Cancer Research Foundation: Breast Cancer in the Elderly</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249663/' target='_blank'>Journal Article: Use of Cyclin-Dependent Kinase 4/6 (CDK4/6) Inhibitors in Older Patients</a> </li></ul>
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26

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

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

PHASE: II

NCT ID: NCT04567420

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

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

Purpose
To study the anti-cancer activity, safety, and side effects of using a ctDNA blood test to guide treatment decisions in people who are taking anti-hormone therapy after surgery.
Who is this for?
People with stage II or stage III estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer. You must be taking hormone therapy after surgery for at least the last 6 months. Your cancer must be considered at high risk for recurrence (coming back). See below for the definition of high-risk.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream. </li> <li class="seamTextUnorderedListItem">Researchers are studying if a test looking for ctDNA in the bloodstream can determine if there will be a recurrence (coming back) of a person's breast cancer. </li> <li class="seamTextUnorderedListItem">The ctDNA blood test used in this trial is called Signatera. </li> <li class="seamTextUnorderedListItem">This trial is also studying if a recurrence can be stopped or delayed by giving people with a positive ctDNA test additional treatment.</li> <li class="seamTextUnorderedListItem">The additional treatment in this trial includes Palbociclib (Ibrance®) and Fulvestrant (Faslodex®).</li> <li class="seamTextUnorderedListItem">Palbociclib is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Fulvestrant is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader). It is approved to treat some people with advanced HR+ breast cancer.</li> <li class="seamTextUnorderedListItem">For this trial, some of the definitions of cancer at high risk of recurrence include: </li> <li class="seamTextUnorderedListItem">Cancer found in 4 or more lymph nodes, or </li> <li class="seamTextUnorderedListItem">A tumor 5 cm or larger, or</li> <li class="seamTextUnorderedListItem">Cancer found in 1 to 3 lymph nodes, and your tumor was at least 3 cm, or grade 3 or, your Oncotype DX score was greater than 26, MammaPrint score was high risk, EndoPredict was greater than 4, or Prosigna score was greater than 60.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04567420' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>What is Circulating Tumor DNA and How is it Used to Diagnose and Manage Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.natera.com/oncology/signatera-advanced-cancer-detection/' target='_blank'>Natera ctDNA Test Information Page: Signature</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2021/a-tale-of-two-cdk46-inhibitors-in-early-breast-cancer/' target='_blank'>The ASCO Post: A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer</a> </li></ul>
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27

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

VISITS: 2 visits in 1 month, then monthly

PHASE: II

NCT ID: NCT05524584

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) and anastrozole (Arimidex®) hormone therapies with abemaciclib (Verzenio®) CDK 4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that is newly diagnosed or that progressed at least 1 year after finishing standard treatment. You must not have received treatment with fulvestrant (Faslodex®) or a CDK 4/6 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is type of hormone therapy called an aromatase inhibitor. It is commonly used to treat early-stage and metastatic hormone-positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05524584' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
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28

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

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

PHASE: I

NCT ID: NCT05870579

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

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

Purpose
To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with ribociclib (Kisqali®) targeted therapy and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low, gastrin releasing peptide receptor (GRPR) positive (GRPR+) breast cancer who have received no more than 1 line of therapy for advanced disease.    Full eligibility criteria
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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">177Lu-Lu-NeoB, by IV, monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">PET scans with 68Ga-Ga-NeoB, by IV, 2-3 times</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are developing a new class of drugs called radiopharmaceuticals, which deliver radiation therapy directly and specifically to cancer cells.</li> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB is an experimental radiation therapy drug called a radiopharmaceutical or radioactive drug.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The experimental tracer in this study is 68Ga-Ga-NeoB.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug every month that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05870579' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/NCT05870579' target='_blank'>Novartis: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.moffitt.org/diagnostic-services/radiology-diagnostic-imaging-and-interventional-radiology/services-and-locations/radiopharmaceuticals/#:~:text=Radiopharmaceuticals%20are%20a%20unique%20class,linker%20that%20joins%20the%20two.' target='_blank'>Moffitt Cancer Center: Radiopharmaceuticals</a> </li></ul>
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29

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

VISITS: Monthly for up to 6 months

PHASE: II

NCT ID: NCT07227233

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

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

Purpose
To see if using an artificial intelligence (AI) tool can help identify who may benefit from taking a second CDK4/6 inhibitor.
Who is this for?
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 CDK4/6 inhibitor.    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 randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor that is different from the one you previously took</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> <li class="seamTextUnorderedListItem">Checkups, tests, and questionnaires, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treatment chosen by the doctor, but will not include CDK4/6 inhibitors</li> <li class="seamTextUnorderedListItem">Checkups, tests, and questionnaires, monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Researchers believe that the AI tool will be able to predict who will respond to a second CDK4/6 inhibitor combined with fulvestrant (Faslodex) and that they will have better outcomes (longer progression free survival, higher overall response rate, higher clinical benefit rate, and better quality of life).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07227233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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30

NEAREST SITE: 447 miles
UC San Diego Moores Cancer Center
La Jolla,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07029399

NKT5097 Targeted Therapy for Advanced Breast Cancer

A Phase 1, First-in-Human, Open-Label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral Selective CDK2/CDK4 Dual Degrader NKT5097 in Adults With Advanced/Metastatic Solid Tumors Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of NKT5097, an experimental CDK2/4 degrader.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer.    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">NKT5097, by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT5097 is an experimental targeted therapy called a CDK2/4 degrader. It breaks down two enzymes, CDK2 and CDK4, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07029399' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2023/12/what-is-protein-degradation/' target='_blank'>Dana-Farber Cancer Institute: Protein Degraders for Cancer</a> </li></ul>
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31

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. They are commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05467891' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</a> </li></ul>
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32

NEAREST SITE: 538 miles
Providence Cancer Institute
Portland,OR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05867251

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

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

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARTS-021, an experimental CDK2 inhibitor, alone or with other anti-cancer drugs.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease.    Full eligibility criteria
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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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05867251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/' target='_blank'>Avenzo Therapeutics: ARTS-021 Drug and Trial Information Page</a> </li></ul>
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33

NEAREST SITE: 590 miles
Intermountain Health
Salt Lake City,UT

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06586957

NKT3964 Targeted Therapy for Advanced HR+, HER2- Breast Cancer

A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors Scientific Title

Purpose
To study the safety, best dose, and effects (good and bad) of NKT3964, an experimental CDK2 PROTAC degrader.
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 no standard treatment options available. You must have received 0-1 line of chemotherapy for advanced 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3964, by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3964 is an experimental targeted therapy called a CDK2 PROTAC degrader that breaks down CDK2 to slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06586957' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nikangtx.com/science-and-pipeline/' target='_blank'>NiKang Therapeutics: NKT3964 Drug Information Page</a> </li></ul>
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34

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

VISITS: 1-2 visits every month

PHASE: I

NCT ID: NCT06515470

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

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

Purpose
To study the safety, best dose, and effects (good and bad) of BTX-9341, an experimental CDK4/6 inhibitor, with fulvestrant (Faslodex®) hormone therapy.
Who is this for?
Advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1-2 lines of hormone therapy with CDK4/6 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-9341, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-9341 is an experimental targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06515470' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biotheryx.com/pipeline/' target='_blank'>Biotheryx: BTX-9341 Drug Information Page</a> </li></ul>
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35

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

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT06377852

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

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

Purpose
To study increasing the dose of CDK4/6 inhibitors to help people manage side effects and continue taking CDK4/6 inhibitors as prescribed.
Who is this for?
People at least 65 years old with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who are planning to receive a CDK4/6 inhibitor with hormone therapy.    Full eligibility criteria
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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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Regular dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Increasing low dose of palbociclib (Ibrance®) or ribociclib (Kisqali®), by mouth, daily for 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in group 1, you will continue the normal dose (unless you need to decrease the dose due to challenging side effects).</li> <li class="seamTextUnorderedListItem">If you are in group 2, you will increase your dose every month (unless you have challenging side effects) up to the normal dose.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06377852' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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36

NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT

VISITS: 5 visits a month, ongoing

PHASE: I

NCT ID: NCT04315233

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE) Scientific Title

Purpose
To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>
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37

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05735080

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

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

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of INX-315, an experimental CDK2 inhibitor, alone or with other anti-cancer therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK4/6 inhibitor or CCNE1 amplified breast cancer with no standard treatment options available.    Full eligibility criteria
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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 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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degraders (SERD) are a type of hormone therapy that bind to and break down estrogen receptors. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are a type of targeted therapy that block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CCNE1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05735080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://incyclixbio.com/our-science/' target='_blank'>Incyclix Bio Drug Information Page: INX-315</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy and SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li></ul>
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38

NEAREST SITE: 666 miles
University of Washington
Seattle,WA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04841148

Preventing Stage II-III ER+, HER2- Breast Cancer with DTCs from Spreading

A Phase II Trial of Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer (PALAVY) Scientific Title

Purpose
To study if hydroxychloroquine (Plaquenil®) malaria drug and avelumab (Bavencio®) immunotherapy, with or without palbociclib (Ibrance®) targeted therapy, can prevent breast cancer from spreading.
Who is this for?
People with stage II or stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who are receiving hormone therapy after surgery. You must have disseminated tumor cells (DTCs) in your bone marrow detected by the University of Pennsylvania.    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 randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily for 3 weeks on, 1 week off for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily for 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disseminated tumor cells (DTCs) are single cancer cells that have moved from the tumor to somewhere else in the body, often the bone marrow.</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®) is a drug commonly used to prevent and treat malaria. It may also prevent cancer from spreading.</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">Avelumab (Bavencio®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04841148' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://time.com/2870100/treating-cancer-with-a-malaria-drug/' target='_blank'>TIME: Hydroxychloroquine (Plaquenil®) for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Avelumab (Bavencio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li></ul>
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39

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

VISITS: Number of visits unavailable, up to 3 years

PHASE: II

NCT ID: NCT07112053

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of an experimental vaccine called STEMVAC in combination with standard hormone therapy or capecitabine (Xeloda®).
Who is this for?
People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer. You must be receiving hormone therapy and a CDK4/6 inhibitor, or have become resistant to hormone therapy and have received at least one cycle of capecitabine (Xeloda®).    Full eligibility criteria
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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: Hormone Therapy Sensitive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hormone therapy</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Hormone Therapy Resistant</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth</li> <li class="seamTextUnorderedListItem">STEMVAC, by injection, 5 times within 9 months, then every 6 months</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> <li class="seamTextUnorderedListItem">FES PET scan</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The STEMVAC vaccine targets proteins expressed on breast cancer stem cells and may boost the ability of the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Hormone therapy blocks the effects of estrogen to block the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07112053' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/vaccines-mbc/' target='_blank'>Metastatic Trial Talk: Vaccines for MBC</a> </li></ul>
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40

NEAREST SITE: 682 miles
Fred Hutchinson Cancer Research Center
Seattle,WA

VISITS: At least 1 visit every month

PHASE: I

NCT ID: NCT06756932

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of BGB-21447, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy, with or without BGB-43395, an experimental CDK4 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received at least 2 lines of therapy for advanced disease and hormone therapy with a CDK4/6 inhibitor for early stage or advanced disease.    Full eligibility criteria
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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">BGB-21447, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-21447, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-21447 is an experimental targeted therapy called a Bcl-2 Inhibitor. Blocking Bcl-2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">BGB-43395 is an experimental targeted therapy called a CDK4 inhibitor. CDK4 is a type of protein that regulates cell growth and division in your body. Blocking CDK4 is believed to have anti-tumor effects.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06756932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li></ul>
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41

NEAREST SITE: 682 miles
Fred Hutchinson Cancer Research Center
Seattle,WA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT07222267

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of BG-75202 KAT6A/B inhibitor alone and in combination with other therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received 1 to 3 prior lines of therapy. You must not have received more than 2 lines that included chemotherapy and/or an antibody-drug conjugate (ADC).    Full eligibility criteria
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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">BG-75202, by mouth</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Aromatase inhibitor, by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BG-75202 is a KAT6A/B inhibitor. KAT6 allows tumor growth to continue.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow. CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07222267' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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42

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

VISITS: Number of visits unavailable, up to 3.5 years

PHASE: III

NCT ID: NCT07085767

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of palazestrant oral SERD/CERAN plus ribociclib (Kisqali®) CDK4/6 inhibitor versus letrozole (Femara®) hormone therapy plus ribociclib (Kisqali®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not yet received treatment for their advanced cancer. You must not have received fulvestrant (Faslodex®) or elacestrant (Orserdu®) at any time.    Full eligibility criteria
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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">Palazestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Placebo for letrozole (Femara®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for palazestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant is an experimental hormone therapy called a SERD (selective estrogen receptor degrader). SERDs work by binding to and breaking down estrogen receptors. Palazestrant is also a CERAN (complete ER antagonist), meaning that it blocks the function of estrogen receptors. </li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07085767' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/new-hormone-therapies/' target='_blank'>Metastatic Trial Talk: Oral SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/pipeline/' target='_blank'>Olema: Palazestrant</a> </li></ul>
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43

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06120283

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

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

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of BGB-43395, an experimental CDK4 inhibitor, alone or with fulvestrant (Faslodex®) or letrozole (Femara®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received hormone therapy and a CDK4/6 inhibitor. You must not have received more than 2 lines of chemotherapy for advanced disease.    Full eligibility criteria
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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">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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395 is an experimental targeted therapy called a CDK4 inhibitor. It may block the enzymes CDK4 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal women will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06120283' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/?utm_medium=email&utm_source=subscribers&utm_campaign=Jan2024&utm_content=Email012024' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li></ul>
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44

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05501704

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) hormone therapy for male breast cancer.
Who is this for?
Men with newly diagnosed stage I, stage II, or stage III hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer who have not yet received treatment.    Full eligibility criteria
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  • <p class="seamTextPara"> This trial has two parts. In part 1, 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 for 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, 1 time</li> </ul> <p class="seamTextPara"> In part 2, you will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, monthly for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily for 4 months</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®), by injection, monthly for 4 months</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 4 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. Tamoxifen is the standard of care for the treatment of breast cancer in men.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow. Anastrozole is a standard treatment in women with breast cancer and works more effectively than tamoxifen.</li> <li class="seamTextUnorderedListItem">Degarelix (Firmagon®) is approved to treat prostate cancer. It lowers the body's production of testosterone. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501704' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials/22-225' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/degarelix.html' target='_blank'>Drugs.com: Degarelix (Firmagon®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
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45

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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  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">A drug holiday is a planned period of time that you decide with your doctor to stop taking a medication. In some cases, a drug holiday can allow a medication to become effective again.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put you in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305924' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/drug-holiday-definition-risks-and-benefits-2248870' target='_blank'>Verywell Health: Drug Holiday</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/pathology-report/hormone-receptor-status' target='_blank'>Breastcancer.org: Hormone Receptor Status</a> </li></ul>
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46

NEAREST SITE: 1643 miles
The University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04872166

BTX-A51 Targeted Therapy for Advanced ER+, HER2- Breast Cancer

An Open Label, Escalating Multiple Dose Study to Evaluate the Safety, Toxicity, and Pharmacokinetics of BTX A51 in Subjects With Advanced Solid Tumors and Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Metastatic Breast Cancer Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of BTX-A51, an experimental multi-kinase 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 no standard treatment options available.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-A51, by mouth, 5 days on, 2 days off</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-A51 is an experimental targeted therapy called a multi-kinase inhibitor that blocks CK1α and CDK7/9.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04872166' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.edgewoodoncology.com/science' target='_blank'>Edgewood Oncology: BTX-A51 Drug Information Page</a> </li></ul>
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47

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 being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421 is an experimental type of targeted therapy called a CDK2 inhibitor. CDK2 inhibitors may block the enzyme CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Camizestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are a type of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06188520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html' target='_blank'>AstraZeneca: AZD8421 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li></ul>
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48

NEAREST SITE: 1856 miles
Northwestern University
Chicago,IL

VISITS: 5 visits within 5 years

PHASE: II

NCT ID: NCT06062498

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy alone or combined with a CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received at least 2 types of hormone therapy, at least one of which was received in combination with a CDK4/6 inhibitor for your advanced or metastatic cancer. You must not have received elacestrant (Orserdu®).    Full eligibility criteria
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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">Elacestrant (Orserdu®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitor, by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">You will receive a CDK4/6 inhibitor that you have not previously received.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®). In this study, abemaciclib (Verzenio®) is received daily. Palbociclib (Ibrance®) and ribociclib (Kisqali®) are received daily, 3 weeks on, 1 week off.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06062498' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.orserdu.com/' target='_blank'>Menarini: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/hormone-therapy-resistance/' target='_blank'>Metastatic Trial Talk: Treatments to Overcome Resistance to Hormone Therapy</a> </li></ul>
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49

NEAREST SITE: 1955 miles
University of Michigan Health West
Wyoming,MI

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05996107

CDK4/6 Inhibitor With Radiation After Surgery for Stage III HR+, HER2-, Node Positive Breast Cancer

A Phase 1B Study of Ribociclib Administered Concurrently With Postoperative Radiation Therapy in Patients With High-Risk, Node Positive, HR+/HER2- Breast Cancer Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®) CDK4/6 inhibitor given at the same time as radiation after surgery.
Who is this for?
Women with stage III hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-), node positive breast cancer who have completed surgery and chemotherapy. You must not have received chest wall radiation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily for 1.5 months</li> <li class="seamTextUnorderedListItem">Radiation, 16-25 sessions within 1-2 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Node positive means cancer has spread to your lymph nodes.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05996107' 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/radiation-therapy' target='_blank'>Breastcancer.org: Radiation</a> </li></ul>
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50

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04923542

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

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

Purpose
To study the anti-cancer activity and side effects of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®), hormone therapy, and stereotactic radiation therapy together to treat brain metastases.
Who is this for?
People with metastatic (stage IV) hormone receptor-positive, HER2 negative (HER2-) breast cancer that has spread to the brain.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. This stops cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Anti-estrogen therapies are commonly used to treat hormone receptor-positive breast cancer. These drugs are also called endocrine or hormone therapy and include tamoxifen, aromatase inhibitors, fulvestrant, and others. </li> <li class="seamTextUnorderedListItem">The hormone therapies used in this trial are fulvestrant and aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04923542' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/?s=brain+mets' target='_blank'>Metastatic Trial Talk: Topics for Breast Cancer Brain Mets</a> </li></ul>
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51

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06409390

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

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

Purpose
To study a new order of giving currently approved drugs to treat metastatic breast cancer.
Who is this for?
Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received an aromatase inhibitor or tamoxifen (Nolvadex®).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) or trastuzumab deruxtecan (Enhertu®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) or abemaciclib (Verzenio®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Researchers are continually developing new drugs to treat metastatic breast cancer (MBC) and understanding how to best use drugs already approved for MBC.</li> <li class="seamTextUnorderedListItem">An important question in treatment planning is the order in which drugs are given, called “drug sequencing”.</li> <li class="seamTextUnorderedListItem">All drugs in this trial are approved for metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), docetaxel (Taxotere®), and capecitabine (Xeloda®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) and trastuzumab deruxtecan (Enhertu®) are types of targeted therapy called antibody drug conjugates (ADC).</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06409390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/drug-sequencing/?utm_medium=email&utm_source=subscribers&utm_campaign=Mar2024&utm_content=Email032024' target='_blank'>Metastatic Trial Talk: What is “Drug Sequencing”?</a> </li></ul>
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52

NEAREST SITE: 2517 miles
Abramson Cancer Center of the University of Pennsylvania
Philadelphia,PA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04523857

Abemaciclib CDK4/6 Inhibitor With or Without Hydroxychloroquine for Stage I-III Breast Cancer At Risk of Recurrence

A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY") Scientific Title

Purpose
To study the safety, effects (good and bad), and ability of abemaciclib (Verzenio®) CDK4/6 inhibitor with and without hydroxychloroquine (Plaquenil®), an experimental cancer drug, to reduce or eliminate breast cancer cells in the bone marrow.
Who is this for?
People with stage I, stage II, or stage III breast cancer who completed treatment and have one of the following recurrence risk factors: 1) lymph node positive; 2) triple negative (ER-, PR-, HER2-); 3) estrogen receptor positive (ER+), HER2 negative (HER2-), lymph node negative; 4) leftover tumor found in your breast or lymph node (residual disease) after neoadjuvant (before surgery) chemotherapy. You must not have received treatment with a CDK4/6 inhibitor.    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 randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®), by mouth, daily for 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Hydroxychloroquine (Plaquenil®) is an experimental cancer drug that may help cancer drugs work better.</li> <li class="seamTextUnorderedListItem">The drugs may target bone marrow disseminated tumor cells (DTCs).</li> <li class="seamTextUnorderedListItem">This trial requires bone marrow testing through another research study.</li> <li class="seamTextUnorderedListItem">Residual disease refers to cancer cells that are present after treatment.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04523857' 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://i2b.us/repurposing-drugs-as-expanding-cancer-treatment-palette-hydroxychloroquine/' target='_blank'>Institute of Integrative BioOncology: Hydroxychloroquine for Cancer</a> </li></ul>
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53

NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge (All protocol activities)
Basking Ridge,NJ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06678269

Abemaciclib CDK4/6 Inhibitor with Radiation for People with Metastatic HR+, HER2- Breast Cancer with Bone Metastases

A Phase I Study of Concurrent Abemaciclib and Radiation Therapy (RT) for Patients With Metastatic Hormone Receptor Positive (HR+), HER2 Negative (HER2-) Breast Cancer Scientific Title

Purpose
To test different doses of abemaciclib (Verzenio®) CDK4/6 inhibitor to find the best dose in people receiving radiation.
Who is this for?
People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2-) breast cancer with bone metastases who are planning to receive radiation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06678269' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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54

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06139107

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

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

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) radiation with abemaciclib (Verzenio®) CDK4/6 inhibitor and letrozole (Femara®) aromatase inhibitor.
Who is this for?
Postmenopausal women with stage I, stage II, or some stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received surgery and are not planning to receive chemotherapy before surgery (neoadjuvant). You must have an Oncotype DX score of less than 25.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 3 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily for 2 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">The Oncotype DX test can help determine the chance of the cancer coming back.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with lobular breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06139107' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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55

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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56

NEAREST SITE: 2614 miles
Yale University
New Haven,CT

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06953882

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

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

Purpose
To study whether choosing not to receive chemotherapy after surgery increases the chances of completing treatment with ribociclib (Kisqali®), a CDK 4/6 inhibitor.
Who is this for?
People with stage II or some stage III estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an Oncotype DX Recurrence Score ≤ 25 who are planning to receive ribociclib (Kisqali®) and hormone therapy. You must have received surgery and cancer was found in your lymph nodes.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will choose to be in 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off, for 1 year</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily, for 1 year</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®) (if male or premenopausal female only), by injection, monthly, for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: With Chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy, for 1 year</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on 1 week off, for 1 year</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily, for 1 year</li> <li class="seamTextUnorderedListItem">Goserelin (Zoladex®) (if male or premenopausal female only), by injection, monthly, for 1 year</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In clinical trials, around one-third of patients stopped taking CDK 4/6 inhibitors before it was planned due to side effects.</li> <li class="seamTextUnorderedListItem">The OncotypeDx 21-gene Breast Recurrence Score Test is a biomarker test that predicts the benefit of chemotherapy in certain people with breast cancer.</li> <li class="seamTextUnorderedListItem">An OncotypeDx recurrence score of 0-25 indicates a less aggressive cancer that will not benefit from chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06953882' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.exactsciences.com/cancer-testing/oncotype-dx-breast-recurrence-score-patients/test-results' target='_blank'>Exact Sciences: Oncotype DX Breast Recurrence Score Test</a> </li></ul>
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57

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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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
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58

NEAREST SITE: 2693 miles
Massachusetts General Hospital
Boston,MA

VISITS: Please contact the research site

PHASE: II

NCT ID: NCT02896335

Targeted Therapy Palbociclib for Brain Metastases

A Phase 2 Study of Palbociclib in Progressive Brain Metastases Harboring Alterations in the CDK Pathway Scientific Title

Purpose
To study the safety, anti-cancer activity, and side effects of giving the CDK 4/6 inhibitor palbociclib (Ibrance®).
Who is this for?
People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). You may not enroll if you have already received a CDK 4/6 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <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 that metastasized to the brain.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02896335' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li></ul>
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59

NEAREST SITE: 2693 miles
Brigham and Women's Hospital
Boston,MA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05608252

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

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

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of VS-6766, an experimental RAF/MEK inhibitor, with abemaciclib (Verzenio®) CDK 4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received treatment with fulvestrant (Faslodex)® for advanced/metastatic disease and a CDK 4/6 inhibitor after surgery (adjuvant) or for advanced/metastatic disease.    Full eligibility criteria
Contact research site
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766 is an experimental targeted therapy called a RAF/MEK inhibitor that targets and interrupts a pathway that allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05608252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verastem.com/research/pipeline/#raf-mek-inhibition' target='_blank'>Verastem: VS-6766 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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