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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: July 15, 2025)
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Treatment
Brain Mets
BRCA1/2 (inherited)
Chemotherapy
Hormone Therapy
Leptomeningeal Disease
Radiation Oncology
Surgery
Surgery: Reconstruction
Targeted Therapy: All
Targeted Therapy: ADC
Targeted Therapy: Anti-HER2 Therapy
Targeted Therapy: CDK Inhibitors
Targeted Therapy: PARP Inhibitors
Targeted Therapy: Tumor Mutations
Targeted Therapy: Other Targeted Therapy
Vaccines and Immunotherapy
Other Treatment
Non-Treatment
Activities
Complementary and Integrative Medicine
Decision Support
Diagnosing Breast Cancer
Genetics/Family History
Having Children
Healthy/High Risk
Imaging
Lymphedema
Managing Side Effects
No Travel Required
Predicting Response to Treatment
Preventing Breast Cancer
Preventing Recurrence
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AKT
ALK
AR
BARD1
BRCA1/2 (tumor)
BRIP1
CD205
CD70
CHEK2 or CHEK1
dMMR/MSI-H
ESR1
FGFR
HER2/ERBB2
HLA
MET or C-Met
NTRK
PALB2
PIK3CA or PI3K
PTEN
RAD51
RAF (including BRAF)
RAS (KRAS or NRAS)
RB
ROS1
TP53
1
NEAREST SITE: 3 miles
Sutter Cancer Research Consortium
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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<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>
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<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, <span class="highlight">CDK4,</span> <span class="highlight">CDK6,</span> <span class="highlight">CDKN2A,</span> 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>
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<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>
2
NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT04606446
Experimental Therapy PF-07248144 for Advanced ER+, HER2- Breast Cancer
A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic Solid Tumors. Scientific Title
Purpose
To study the safety, side effects, dose, and anti-cancer activity of giving PF-07248144 alone, in combination with fulvestrant, or with palbociclib and letrozole.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed after receiving a CDK 4/6 inhibitor and anti-estrogen therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07248144 is a KAT6 Inhibitor</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04606446' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04606446' target='_blank'>Pfizer Trial Information Page: PF-07248144</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/update-on-hormone-receptor-positive-mbc-2021/' target='_blank'>Metastatic Trial Talk: Update on Hormone Receptor-Positive MBC</a> </li></ul>
3
NEAREST SITE: 3 miles
University of California, San Francisco (UCSF)
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT04802759
Experimental Anti-Estrogen Therapy Alone or with Targeted Therapy or Chemotherapy for Women with Advanced ER+, HER2- Breast Cancer
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS- BREAST CANCER) Scientific Title
Purpose
To study the anti-cancer activity and safety of giving the experimental anti-estrogen therapy giredestrant alone or with a CDK 4/6 inhibitor, an AKT inhibitor, a PI3K inhibitor, or chemotherapy.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) estrogen-receptor positive (ER+), HER2-negative (HER2-) breast cancer whose disease progressed while taking anti-hormone therapy with a CDK 4/6 inhibitor and who have not received chemotherapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib, by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant is an experimental anti-estrogen therapy you take by mouth. It is a type of anti-estrogen therapy called a SERD (selective estrogen receptor degrader).</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors. The only SERD currently approved to treat breast cancer is fulvestrant (Faslodex®). Faslodex is given by injection. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor -- it blocks two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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 <span class="highlight">CDK</span> 4/6 inhibitor. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an experimental type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT. </li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental type of targeted therapy called a PI3K inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. Inavolisib may slow or stop cancer cells from growing by blocking this pathway. </li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04802759' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html' target='_blank'>Genentech Drug Information Page: Giredestrant (GDC-9545)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors (Abemaciclib & Ribociclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib (AKT Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib (P13K Alpha Inhibitor)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/everolimus.aspx' target='_blank'>Chemocare: Everolimus (Afinitor)</a> </li></ul>
4
NEAREST SITE: 3 miles
Research Site
San Francisco,CA
VISITS: 1 visit per month, ongoing
PHASE: III
NCT ID: NCT04862663
Capivasertib, Palbociclib, and Fulvestrant for Advanced ER+, HER2- Breast Cancer
A Phase Ib/III Randomised Study of Capivasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer Scientific Title
Purpose
To study the dose, safety, side effects, and anti-cancer activity of giving the targeted therapies capivasertib and palbociclib (Ibrance®) with the anti-estrogen therapy fulvestrant (Faslodex®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer. Your cancer must have progressed on anti-estrogen therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, daily (4 days on, 3 days off), ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy that blocks the Akt protein. The Akt protein helps cancer cells divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. It is approved for treating metastatic hormone-positive, HER2-negative breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04862663' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/capivasertib?redirect=true' target='_blank'>NCI Drug Dictionary: Capivasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(19)30857-5/fulltext' target='_blank'>Journal Article: Capivasertib Inhibits a Key Pathway in Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615013.html' target='_blank'>Medline Plus: Palbociclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Fulvestrant' target='_blank'>Wikipedia: Fulvestrant</a> </li></ul>
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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<p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-1250 is an experimental hormone therapy called a selective estrogen receptor downregulator (SERD) and complete estrogen receptor antagonist (CERAN). SERDs bind to and break down estrogen receptors, and CERANs block estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05508906' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/science/' target='_blank'>Olema Oncology Drug Information Page: OP-1250</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>
6
NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05563220
Elacestrant Hormone Therapy with Anti-Cancer Therapies for Metastatic ER+, HER2- Breast Cancer
A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients With Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy in combination with other anti-cancer therapies.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have not received treatment with chemotherapy or elacestrant (Orserdu®) for advanced/metastatic disease.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on your situation: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), daily</li> <li class="seamTextUnorderedListItem">Physician's choice of palbociclib (Ibrance®), abemaciclib (Verzenio®), or ribociclib (Kisqali®), daily, 3 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called a mTOR inhibitor. mTOR inhibitors work by interfering with the ability of cancer cells to divide and grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called <span class="highlight">CDK</span> 4/6 inhibitors. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK</span> 4 and <span class="highlight">CDK</span> 6, that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05563220' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li></ul>
7
NEAREST SITE: 3 miles
UCSF Medical Center at Mission Bay
San Francisco,CA
VISITS: 1 visit every month
PHASE: I-II
NCT ID: NCT05573555
ARV-471 Hormone Therapy with Ribociclib for Advanced ER+, HER2- Breast Cancer
TACTIVE-U: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL UMBRELLA STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF ARV-471 (PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH OTHER ANTICANCER TREATMENTS IN PARTICIPANTS AGED 18 YEARS AND OVER WITH ER+ ADVANCED OR METASTATIC BREAST CANCER, SUB-S... Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARV-471, an experimental PROTAC protein degrader, with ribociclib (Kisqali®) CDK 4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK 4/6 inhibitor and up to 2 lines of therapy for advanced/metastatic disease.
Full eligibility criteria
Contact research site
Share with my doctor
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- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471, by mouth, daily</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARV-471 is an experimental hormone therapy called a PROTAC protein degrader that breaks down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two proteins, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05573555' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://Tactivestudy.com' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct05548127-or-nct05573555-advanced-and-metastatic-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arvinas.com/research-and-development/estrogen-receptor/' target='_blank'>Arvinas Estrogen Receptor: ARV-471 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li></ul>
8
NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT06253130
IMP1734 PARP Inhibitor for Advanced Breast Cancer
A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMP1734, an experimental PARP inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received chemotherapy and 0-1 lines of a PARP inhibitor. You must have a BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) mutation.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253130' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.eikontx.com/#pipeline' target='_blank'>Eikon Therapeutics: IMP1734/EIK1003 Drug Information Page</a> </li></ul>
9
NEAREST SITE: 3 miles
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: 4 visits in 1 month, then 1 visit every month
PHASE: II
NCT ID: NCT06369285
Alisertib Targeted Therapy with Hormone Therapy for Advanced HR+, HER2- Breast Cancer
A Phase 2 Study of Alisertib in Combination with Endocrine Therapy in Patients with HR+, HER2-negative Recurrent or Metastatic Breast Cancer (ALISCA-Breast1) Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of alisertib, an experimental AURKA inhibitor, with standard of care hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have received at least two hormone therapies including a CDK4/6 inhibitor with hormone therapy for advanced disease. You must not have received chemotherapy for advanced disease.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alisertib is an experimental targeted therapy called an Aurora Kinase A (AURKA) inhibitor. Blocking AURKA may slow or stop cancer cells from growing.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06369285' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pumabiotechnology.com/clinical-trials/alisca_breast1.html' target='_blank'>Puma Biotechnology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/the-role-of-mtor-aurora-a-kinase-combination-therapy-requires-further-elucidation-in-solid-tumors' target='_blank'>OncLive: Alisertib for Advanced Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/alisertib' target='_blank'>National Cancer Institute: Alisertib</a> </li></ul>
10
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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Share with my doctor
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- What's involved?
- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem"><span class="highlight">CDK</span> 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"><span class="highlight">CDK</span> inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and giredestrant are a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental SERD.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called <span class="highlight">CDK</span> 4/6 inhibitors. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK</span> 4 and <span class="highlight">CDK</span> 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">The FoundationOne Liquid CDx Assay blood test will identify ctDNA mutations.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06065748' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html#:~:text=This%20compound%20and%20its%20use,US%20Food%20and%20Drug%20Administration.' target='_blank'>Genentech: Giredestrant Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>
11
NEAREST SITE: 22 miles
Contra Costa Regional Medical Center
Martinez,CA
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT06112613
Mobile Health Tools to Help Take Medication as Prescribed for People with Metastatic Breast Cancer
Improving Medication Adherence in Metastatic Breast Cancer Using a Connected Customized Treatment Platform (CONCURxP) Scientific Title
Purpose
To study if WiseBag and CONCURxP mobile health tools will improve the ability of people to take their medication as prescribed compared to WiseBag alone.
Who is this for?
People 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 or started receiving a CDK4/6 inhibitor within the past month.
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: Enhanced Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WiseBag, 1 year</li> <li class="seamTextUnorderedListItem">Educational materials, monthly for 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WiseBag, 1 year</li> <li class="seamTextUnorderedListItem">CONCURxP, 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires, every 3 months for 1 year</li> <li class="seamTextUnorderedListItem">Interviews, 6 months after completing study</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors need to be taken as prescribed to receive the best benefit.</li> <li class="seamTextUnorderedListItem">Using WiseBag and CONCURxP may reduce forgetfulness for taking medications.</li> <li class="seamTextUnorderedListItem">WiseBag is a lunch box sized medication monitoring device that holds and monitors medications.</li> <li class="seamTextUnorderedListItem">The CONnected CUstomized Treatment Platform (CONCURxP) includes personalized text message reminders for missed medications, monitoring of the medications you take, and notifications to doctors about missed doses.</li> <li class="seamTextUnorderedListItem">CONCURxP sends a text message when a medication is not taken when it should be.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06112613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/managing-life/staying-on-track-with-treatment' target='_blank'>Breastcancer.org: Following Your Treatment Plan</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>
12
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?
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-
<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy: Exemestane (Aromasin®), letrozole (Femara®), anastrozole (Arimidex®), or tamoxifen (Nolvadex®)</li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth </li> <li class="seamTextUnorderedListItem">With or without: Abemaciclib (Verzenio®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Exemestane (Aromasin®), letrozole (Femara®), and anastrozole (Arimidex®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05952557' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.goodrx.com/conditions/breast-cancer/oral-serd' target='_blank'>GoodRX: What is a SERD?</a> </li></ul>
13
NEAREST SITE: 28 miles
Kaiser Permanente Medical Center - Vallejo
Vallejo,CA
VISITS: 1-3 visits per month
PHASE: III
NCT ID: NCT05501886
Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental pan-PI3K and mTOR inhibitor, with fulvestrant (Faslodex®) hormone therapy, with or without palbociclib (Ibrance®) CDK 4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with or without a PIK3CA mutation who have received treatment with a CDK 4/6 inhibitor with an aromatase inhibitor. You must not have received more than 1 chemotherapy for advanced disease or 2 lines of hormone therapy.
Full eligibility criteria
Contact research site
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- What's involved?
- What's being studied?
- How can I learn more?
-
<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups depending on your cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental, with or without PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental, with or without PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care, without PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: Standard of Care, with PIK3CA Mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K and mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK</span> 4 and <span class="highlight">CDK</span> 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501886' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity Drug Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>
14
NEAREST SITE: 53 miles
Providence Medical Foundation - Santa Rosa, CA
Santa Rosa,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT05696626
Lasofoxifene Hormone Therapy with CDK4/6 Inhibitor for Advanced ER+, HER2- Breast Cancer With an ESR1 Mutation
An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation (ELAINEIII) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of lasofoxifene, an experimental hormone therapy, with abemaciclib (Verzenio®) CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with an ESR1 mutation. You must have received an aromatase inhibitor with palbociclib (Ibrance®) or ribociclib (Kisqali®) CDK4/6 inhibitor as your first line of hormone therapy for advanced disease. You must not have received more than 1 line of chemotherapy for advanced disease.
Full eligibility criteria
Contact research site
Share with my doctor
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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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lasofoxifene is an experimental hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. It blocks two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05696626' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://sermonixpharma.com/lasofoxifene/' target='_blank'>Sermonix Pharmaceuticals: Lasofoxifene Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
15
NEAREST SITE: 186 miles
Renown Health
Reno,NV
VISITS: About 2 times every month for 2 months, then about every month
PHASE: III
NCT ID: NCT06760637
PF-07220060 CDK4 Inhibitor with Hormone Therapy for Newly Diagnosed Advanced HR+, HER2- Breast Cancer
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER PHASE 3 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO CDK4/6 INHIBITOR PLUS LETROZOLE IN PARTICIPANTS OVER 18 YEARS OF AGE WITH HORMONE RECEPTOR (HR)-POSITIVE, HER2-NEGATIVE ADVANCED/METASTATIC BREAST CANCER WHO HAVE NOT RECEIVED ANY PRIOR SYSTEMIC ANTICANCER TREATMENT FOR ADVANCED/METASTA... (FourLight-3) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of PF-07220060, an experimental CDK4 inhibitor, with letrozole (Femara®) hormone therapy compared to standard of care treatment.
Who is this for?
People with newly diagnosed advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received treatment for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care <span class="highlight">CDK4/6</span> inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a <span class="highlight">CDK4</span> inhibitor. <span class="highlight">CDK4</span> is a protein that helps cancer grow. Blocking <span class="highlight">CDK4</span> helps slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and palbociclib (Ibrance®) are types of targeted therapy called <span class="highlight">CDK4/6</span> inhibitors. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06760637' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct06760637-metastatic-breast-cancer-trial?cmp=0db2aa16-cafd-419f-9d33-b4b4540f6dcf&ttype=BA' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/novel-cdk4-inhibitor-shows-activity-and-safety-in-hr-her2-metastatic-breast-cancer' target='_blank'>OncLive: PF-07220060 for Metastatic HR+, HER2- Breast Cancer</a> </li></ul>
16
NEAREST SITE: 336 miles
University of California, Los Angeles (UCLA)
Los Angeles,CA
VISITS: At least 1 visit every month
PHASE: I-II
NCT ID: NCT04115306
PMD-026 Targeted Therapy with Hormone Therapy for Advanced HR+, HER2-, RSK2+ Breast Cancer
Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of PMD-026, an experimental targeted therapy, with fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), RSK2 positive (RSK2+) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental targeted therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04115306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://phoenixmd.ca/pipeline' target='_blank'>Drug Company Information Page: PMD-026</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29498411' target='_blank'>PubMed Abstract: RSK1 Promotes Murine Breast Cancer Growth and Metastasis</a> </li></ul>
17
NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA
VISITS: 1 visit every week
PHASE: I-II
NCT ID: NCT05319873
Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer
A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breas... Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®), trastuzumab (Herceptin®), and tucatinib (Tukysa®) targeted therapies alone or with fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) or HER2 low breast cancer. If you have stage II or some stage III breast cancer, you must not have received treatment or surgery. If you have advanced (some stage III) or metastatic (stage IV) breast cancer, you must have received at least 1 line of anti-HER2 targeted therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), 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">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. It blocks two enzymes, <span class="highlight">CDK</span> 4 and <span class="highlight">CDK</span> 6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05319873' 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/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
18
NEAREST SITE: 336 miles
UCLA Jonsson Comp Cancer Center
Los Angeles,CA
VISITS: 5 visits in 1 month, then 1-2 visits every month
PHASE: I
NCT ID: NCT05870579
177Lu-Lu-NeoB Radioactive Drug with Ribociclib and Fulvestrant for Advanced ER+, HER2- or HER2 Low, GRPR+ Breast Cancer
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative and Gastrin Releasing Peptide Receptor Positive Advanced Breast Cancer Experiencing Early Relapse From (Neo)Adjuvant Endocr... Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with ribociclib (Kisqali®) targeted therapy and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low, gastrin releasing peptide receptor (GRPR) positive (GRPR+) breast cancer who have received no more than 1 line of therapy for advanced disease.
Full eligibility criteria
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<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>
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<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 <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<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>
19
NEAREST SITE: 336 miles
UCLA Medical Center
Los Angeles,CA
VISITS: 1 visit every 3 weeks for 9 months, then every 1.5 months
PHASE: I-II
NCT ID: NCT06247995
Radioactive Drug with Chemotherapy for Metastatic ER+, HER2- or HER2 Low, GRPR+ Breast Cancer
A Phase I/II, Open-label, Multi-center Trial of [177Lu]Lu-NeoB in Combination With Capecitabine in Adult Patients With Gastrin Releasing Peptide Receptor Positive, Estrogen Receptor-positive, Human Epidermal Growth Factor Receptor-2 Negative Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inh...(NeoB-Cap1) Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of 177Lu-Lu-NeoB, an experimental radioactive drug, with capecitabine (Cytoxan®) chemotherapy.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer that is GRPR positive (GRPR+) who have received no more than 3 lines of hormone therapy (including a CDK4/6 inhibitor) for metastatic disease. You must not have received more than 1 line of chemotherapy or antibody drug conjugate (ADC) for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">177Lu-Lu-NeoB, by IV, every 3-6 weeks</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®), by mouth, daily, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">PET/CT or PET/MRI scan with 68Ga-Ga-NeoB, by IV, 1-2 times</li></ul>
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<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">177Lu-Lu-NeoB targets tumors that are positive for GRPR (gastrin releasing peptide receptor).</li> <li class="seamTextUnorderedListItem">Capecitabine (Cytoxan®) is an FDA-approved chemotherapy drug.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06247995' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/clinicaltrials/study/NCT06247995' 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>
20
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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<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"><span class="highlight">CDK4/6</span> 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"><span class="highlight">CDK4/6</span> inhibitor, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li></ul>
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<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 <span class="highlight">CDK4/6</span> inhibitors. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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>
21
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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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B, by mouth</li> <li class="seamTextUnorderedListItem">Hormone therapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RGT-419B is an experimental type of targeted therapy called a <span class="highlight">CDK</span> 2/4/6 inhibitor. It is designed to block three enzymes, <span class="highlight">CDK2,</span> <span class="highlight">CDK4,</span> and <span class="highlight">CDK6,</span> that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive one of the following types of hormone therapy that you have already received: selective estrogen receptor degrader (SERD), selective estrogen receptor modulator (SERM), or aromatase inhibitor.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05304962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biospace.com/article/releases/regor-therapeutics-announces-u-s-fda-authorization-to-conduct-regor-s-first-in-human-clinical-trial-with-the-next-generation-targeted-inhibitor-rgt-419b-for-oncology/' target='_blank'>Regor Therapeutics Press Release: RGT-419B</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: CDK Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>
22
NEAREST SITE: 341 miles
Ellison Institute
Los Angeles,CA
VISITS: Number of visits unavailable, ongoing
PHASE: I
NCT ID: NCT04557449
An Experimental CDK4 Inhibitor for Advanced Hormone Positive Breast Cancer
A PHASE 1/1B STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS Scientific Title
Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of the experimental targeted therapy PF-07220060.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+) breast cancer who have no standard of care therapies available.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental type of targeted therapy called a cyclin-dependent kinase <span class="highlight">(CDK)</span> inhibitor. </li> <li class="seamTextUnorderedListItem">It blocks the <span class="highlight">CDK4</span> enzyme, which is a protein that helps cancers grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04557449' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/science/drug-product-pipeline' target='_blank'>Pfizer Oncology Drug Information Page: PF-07220060</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/CDK_inhibitor' target='_blank'>Wikipedia: CDK Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/answers/1947145-155365/what-is-the-role-of-hormone-therapy-in-the-treatment-of-metastatic-breast-cancer' target='_blank'>MedScape: What is the Role of Hormone Therapy in the Treatment of Metastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct04557449' target='_blank'>Pfizer Trial Information Page: PF-07220060</a> </li></ul>
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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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®)</li> <li class="seamTextUnorderedListItem">Elacestrant, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Elacestrant is an experimental hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two proteins, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05386108' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/benefit-of-elacestrant-improves-with-longer-duration-of-cdk4-6-inhibition-in-patients-with-er-her2-metastatic-breast-cancer' target='_blank'>OncLive: Benefit of Elacestrant Improves With Longer Duration of CDK4/6 Inhibition in People With ER+/HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/the-emerald-trial-elacestrant-mechanism-of-action-study-design-and-outcomes' target='_blank'>Targeted Oncology: Elacestrant for ER+, HER2- MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>
24
NEAREST SITE: 342 miles
Clinical Trial Site
Los Angeles,CA
VISITS: Coincides with routine care
PHASE: III
NCT ID: NCT06016738
Palazestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer
A Phase 3 Randomized, Open-Label Study Of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of palazestrant (OP-1250), an experimental hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. You must not have received chemotherapy or more than 2 lines of hormone therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant (OP-1250)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy: fulvestrant (Faslodex®), anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palazestrant (OP-1250) and fulvestrant (Faslodex®) are types of hormone therapy called selective estrogen receptor degraders (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is approved, and palazestrant (OP-1250) is experimental.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06016738' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://opera01study.com/' target='_blank'>Olema Pharmaceuticals: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/pipeline/' target='_blank'>Olema Pharmaceuticals: Palazestrant (OP-1250) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oral-serds/' target='_blank'>Metastatic Trial Talk: Update on Oral SERDs for Estrogen Receptor-Positive MBC</a> </li></ul>
25
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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<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>
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<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 <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two proteins, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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>
26
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,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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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a <span class="highlight">CDK</span> 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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>
27
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB123667 is an experimental type of targeted therapy called a <span class="highlight">CDK</span> 2/CDK2 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 2 inhibitors block the enzyme/protein <span class="highlight">CDK2</span> that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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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NEAREST SITE: 366 miles
Cancer and Blood Specialty Clinic ( Site 0001)
Los Alamitos,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT06312176
Sacituzumab Tirumotecan ADC for Advanced HR+, HER2- Breast Cancer
An Open-label, Randomized Phase 3 Study of MK-2870 as a Single Agent and in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of sacituzumab tirumotecan, an experimental antibody drug conjugate (ADC), alone or with pembrolizumab (Keytruda®) PD-1 inhibitor, compared to standard of care chemotherapy.
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 with a CDK4/6 inhibitor for advanced disease. You must not have received chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (MK-2870), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (MK-2870), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab tirumotecan (MK-2870) is an experimental targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab tirumotecan (MK-2870) targets TROP2 proteins. It delivers the chemotherapy belotecan.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06312176' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Sacituzumab Tirumotecan (MK-2870) Drug Information Page</a> </li></ul>
29
NEAREST SITE: 374 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT03994796
Genetic Testing for Choosing a Targeted Therapy for Brain Metastases that Test Positive for Certain Mutations
Genomically-Guided Treatment Trial in Brain Metastases Scientific Title
Purpose
To study the anti-cancer activity of choosing a targeted therapy for brain metastases based on the genetic mutations found in your tumors.
Who is this for?
People with metastatic (stage IV) breast cancer that has spread (metastasized) to your brain with a gene mutation or alteration in: NTRK, ROS1, CDK or PI3K. You must have already received at least one treatment for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups depending on which genetic mutations are found in your tumors: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: <span class="highlight">CDK-mutation</i></span> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: PI3K-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: NTRK or ROS1-mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, daily, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples from your brain and other parts of your body will be tested for mutations. This is called genomic testing.</li> <li class="seamTextUnorderedListItem">You will be assigned a targeted therapy based on which genetic mutations are found in your tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK, ROS1, <span class="highlight">CDK,</span> PI3K</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03994796' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/hcp/patient-profiles' target='_blank'>Eli Lilly & Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rozlytrek.com' target='_blank'>Genentech USA Drug Information Page: Rozlytrek (Entrectinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-inhibitor-gdc-0084' target='_blank'>NCI Drug Dictionary: GDC-0084</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>Journal Article: Targeting the Sanctuary Site, Options when Breast Cancer Metastasizes to the Brain</a> </li></ul>
30
NEAREST SITE: 374 miles
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange,CA
VISITS: 2 visits in 1 month, then monthly
PHASE: II
NCT ID: NCT05524584
Hormone Therapy and Targeted Therapy for Advanced HR+, HER2- Breast Cancer
Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) and anastrozole (Arimidex®) hormone therapies with abemaciclib (Verzenio®) CDK 4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that progressed at least 1 year after finishing standard treatment. You must not have received treatment with fulvestrant (Faslodex®) or a CDK 4/6 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05524584' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
31
NEAREST SITE: 381 miles
Hoag Memorial Hospital Presbyterian
Newport,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05455619
Evexomostat for Women with Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation and High Blood Sugar
Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of evexomostat (SDX-7320), an experimental polymer drug conjugate, with fulvestrant (Faslodex®) hormone therapy and alpelisib (Piqray®) PI3K inhibitor.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation who have high blood sugar. You must have received hormone therapy and a CDK 4/6 inhibitor.
Full eligibility criteria
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- What's being studied?
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-
<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05455619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amelia1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>
32
NEAREST SITE: 381 miles
Hoag Memorial Presbyterian
Newport Beach,CA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT06257264
BG-68501 CDK2 Inhibitor for Women with Advanced HR+, HER2- Breast Cancer
A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of BG-68501, an experimental CDK2 inhibitor.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer.
Full eligibility criteria
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-
<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BG-68501</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BG-68501</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BG-68501 is an experimental targeted therapy called a <span class="highlight">CDK2</span> inhibitor. <span class="highlight">CDK2</span> inhibitors block the enzyme/protein <span class="highlight">CDK2</span> 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">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06257264' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/clinical-trials/a-study-to-examine-the-safety-of-different-doses-of-bg-68501-given-to-participants-with-advanced-stage-tumors/' target='_blank'>BeiGene: Trial Information Page</a> </li></ul>
33
NEAREST SITE: 538 miles
Providence Portland Medical Center
Portland,OR
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05467891
Targeted Therapy and Hormone Therapy for Stage I-III HR+, HER2- Breast Cancer That Has Recurred Locally
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®) CDK 4/6 inhibitor with hormone therapy.
Who is this for?
People with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer that has recurred locally (in the same breast, armpit, chest wall, or some lymph nodes) who have received surgery and/or radiation within the last 6 months.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off for 3 years</li> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy: Fulvestrant (Faslodex®), by injection, 2 times in 1 month then monthly for 5 years, or anastrozole (Arimidex®), letrozole (Femara®), or exemestane (Aromasin®), by mouth, daily for 5 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. They are commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05467891' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromasin' target='_blank'>Breastcancer.org: Exemestane (Aromasin®)</a> </li></ul>
34
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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-
<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3964, by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NKT3964 is an experimental targeted therapy called a <span class="highlight">CDK2</span> PROTAC degrader that breaks down <span class="highlight">CDK2</span> 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>
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<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>
35
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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<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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-9341 is an experimental targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> 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>
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<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>
36
NEAREST SITE: 595 miles
START - Mountain Region
West Valley City,UT
VISITS: 10-12 visits in the first 2 months, then 2 visits every month
PHASE: I
NCT ID: NCT06784193
OP-3136 Targeted Therapy for Advanced ER+, HER2- Breast Cancer
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants with Advanced or Metastatic Solid Tumors Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of OP-3136, an experimental KAT6A/B inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received 1-3 lines of hormone therapy (including 1 line with a CDK4/6 inhibitor) and no more than 1 line of chemotherapy or antibody-drug conjugate for advanced disease.
Full eligibility criteria
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-
<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-3136, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OP-3136 is an experimental targeted therapy called a KAT6A/B inhibitor. Blocking KAT6A/B may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06784193' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://olema.com/pipeline/' target='_blank'>Olema Pharmaceuticals: OP-3136 Drug Information Page</a> </li></ul>
37
NEAREST SITE: 601 miles
START Mountain
West Valley City,UT
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT06638307
MEN2312 Targeted Therapy Alone or with Hormone Therapy for Advanced HR+ Breast Cancer
A Phase 1, First-in-Human Study of MEN2312, a KAT6 Inhibitor, as Monotherapy and in Combination in Participants With Advanced Breast Cancer Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of MEN2312, an experimental KAT6 inhibitor, alone or with elacestrant (Orserdu®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease. You must have received no more than 6 lines of therapy for advanced disease, including no more than 2 lines of chemotherapy and/or antibody drug conjugates (ADC).
Full eligibility criteria
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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">MEN2312, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN2312, by mouth</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEN2312 is an experimental targeted therapy called a KAT6 inhibitor. Blocking KAT6 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06638307' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://stemline.com/product-pipeline/' target='_blank'>Stemline Therapeutics: MEN2312 Drug Information Page</a> </li></ul>
38
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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-
<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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor--it blocks two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<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>
39
NEAREST SITE: 641 miles
Ironwood Cancer & Research Centers
Glendale,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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<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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and ribociclib (Kisqali®) are a type of targeted therapy called <span class="highlight">CDK4/6</span> inhibitors. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<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>
40
NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT03979508
Abemaciclib Before Surgery for Women with Stage I-III, Triple Negative or ER Low, HER2- Breast Cancer That Did Not Respond to Chemotherapy
Window Trial of Abemaciclib for Surgically Resectable, Chemotherapy-Resistant, Triple Negative Breast Cancer (a BEAUTY Study*) Scientific Title
Purpose
To study the safety and effects of using the CDK 4/6 inhibitor abemaciclib (Verzenio®) after neoadjuvant chemotherapy and before surgery.
Who is this for?
Women with stage I, stage II, or stage III triple negative (ER-, PR- HER2-) or ER Low (1%-10% ER), HER2- breast cancer that did not fully respond to chemotherapy given before surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, for 2 to 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER Low, HER2- breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a <span class="highlight">CDK</span> 4/6 inhibitor approved to treat HR+ and HER2- metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03979508' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: What Are CDK4/6 Inhibitors?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/?utm_source=google&utm_medium=ppc&campaign=6456675261&adgroup=82640243172&ad=378689406892&utm_keyword=kwd-389189556877&gclid=Cj0KCQiAmsrxBRDaARIsANyiD1qSisgRZtObbCNg3aCVnfoCwqXFjJlXYQsig6GLWR1OKy3oM7jjYJIaAtcqEALw_wcB' target='_blank'>Eli Lilly and Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2018/09/01/mbc-news-3/' target='_blank'>Metastatic Trial Talk: Insights Into Treatment Resistance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6523967/' target='_blank'>Journal Article: Updates on the CDK4/6 Inhibitory Strategy and Combinations in Breast Cancer</a> </li></ul>
41
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 being studied?
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<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>
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<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 <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK</span> 4 and <span class="highlight">CDK</span> 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>
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<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>
42
NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA
VISITS: 3 visits in 1 month, then 1 visit every 3 months
PHASE: II
NCT ID: NCT06179303
PET/CT Scan to Predict Response to Abemaciclib for Advanced ER+, HER2- Breast Cancer
A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer Scientific Title
Purpose
To study how well functional imaging PET/CT scans with FFNP can predict your cancer's response to abemaciclib (Verzenio®) CDK4/6 inhibitor with standard of care hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+ or ER low), HER2 negative (HER2-) or HER2 low breast cancer who are planning to receive abemaciclib (Verzenio®). You must have received no more than 1 line of chemotherapy for advanced disease. You must not have liver only metastases.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PET/CT scan with FFNP, by IV, 3 times in 1 month, then every 3 months</li> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 1 day</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two proteins, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">FFNP PET/CT imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that <q>light up</q> with FFNP than a PET scan alone can provide.</li> <li class="seamTextUnorderedListItem">Estradiol is type of hormone therapy for advanced ER+ breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or FISH -.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06179303' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection or letrozole (Femara®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-43395 is an experimental targeted therapy called a <span class="highlight">CDK4</span> inhibitor. It may block the enzymes <span class="highlight">CDK4</span> that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal women will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06120283' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-resistance/?utm_medium=email&utm_source=subscribers&utm_campaign=Jan2024&utm_content=Email012024' target='_blank'>Metastatic Trial Talk: Overcoming Resistance to CDK4/6 Inhibitors</a> </li></ul>
44
NEAREST SITE: 1387 miles
University of Oklahoma Health Sciences Center
Oklahoma City,OK
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04550494
PARP Inhibitor Talazoparib for Advanced Breast Cancer that Tests Positive for Certain DNA Repair Mutations
A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response Scientific Title
Purpose
To study and compare the anti-cancer activity of giving the PARP inhibitor talazoparib (Talzenna®) to people who have already received a PARP inhibitor to people who have never received a PARP inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer whose disease progressed on at least one standard of care therapy for advanced disease and who have inherited (or whose tumor tests positive for) one of the several targets or mutations listed below.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor that is approved to treat people with advanced or metastatic HER2 negative (HER2-) breast cancer and an inherited BRCA1 or BRCA2 mutation, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ATM, BACH1 (BRIP1), BARD1, BRCA1/2 (tumor or inherited), <span class="highlight">CDK12,</span> CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM and FANCN</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04550494' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700051780449266' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li></ul>
45
NEAREST SITE: 1388 miles
Oklahoma University
Oklahoma City,OK
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05867251
ARTS-021 CDK2 Inhibitor for Advanced HR+, HER2- or HER2 Low Breast Cancer
A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, MTD/RP2D, and Antitumor Activity of ARTS-021 as a Single Agent and in Combination Therapy in Patients With Solid Tumors Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ARTS-021, an experimental CDK2 inhibitor, alone or with other anti-cancer drugs.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 low breast cancer who have received a CDK4/6 inhibitor with hormone therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) or letrozole (Femara®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ARTS-021 is an experimental targeted therapy called a <span class="highlight">CDK2</span> inhibitor. <span class="highlight">CDK2</span> inhibitors block the enzyme/protein <span class="highlight">CDK2</span> that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy drug.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05867251' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://avenzotx.com/pipeline-and-science/' target='_blank'>Avenzo Therapeutics: ARTS-021 Drug and Trial Information Page</a> </li></ul>
46
NEAREST SITE: 1418 miles
University of Nebraska Medical Center
Omaha,NE
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04762979
Alpelisib and Anti-Hormone Therapy for Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation
A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer Scientific Title
Purpose
To study the anti-cancer activity, safety, and side effects of giving the targeted therapy alpelisib (Piqray®) with an anti-hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that tests positive for a PIK3CA mutation. In addition, you must have already received a CDK 4/6 inhibitor, and you must not have received more than two anti-hormone therapies for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Your doctor's choice of anti-hormone therapy, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04762979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lines-of-therapy-mbc/' target='_blank'>Metastatic Trial Talk: Lines of Therapy for MBC</a> </li></ul>
47
NEAREST SITE: 1418 miles
Unversity of Nebraska Medical Center
Omaha,NE
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05069038
Targeted Therapy and Hormone Therapy for Women with Stage II-III HR+, HER2- Breast Cancer
A Phase II Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy for Post and Pre-menopausal Patients With Early Stage Hormone Receptor Positive and Her-2/Neu Negative Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of palbociclib (Ibrance®) CDK 4/6 inhibitor with letrozole (Femara®) hormone therapy before surgery (neoadjuvant).
Who is this for?
Women with stage II or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received surgery.
Full eligibility criteria
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<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 for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Goserelin, by injection, monthly for 6 months (for premenopausal women)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK</span> 4 and <span class="highlight">CDK</span> 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Premenopausal women will also be given a drug, goserelin, that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05069038' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/zoladex' target='_blank'>Breastcancer.org: Goserelin (Zoladex®)</a> </li></ul>
48
NEAREST SITE: 1455 miles
Sanford Worthington Medical Center
Worthington,MN
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06028022
Reishi Mushroom Extract for Fatigue and Pain for People with Stage 0-III Breast Cancer
Reishi Mushroom Extract for Fatigue and/or Arthralgias in Patients With Breast Cancer on Aromatase Inhibitors: A Randomized Phase II MNCCTN Trial Scientific Title
Purpose
To study the ability of Reishi mushroom extract to reduce fatigue, joint pain, and/or muscle pain.
Who is this for?
Women with stage 0 (DCIS), stage I, stage II, or stage III estrogen receptor positive (ER+) breast cancer who are receiving an aromatase inhibitor and experiencing fatigue. You must not be receiving a CDK4/6 inhibitor or olaparib (Lynparza®).
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">Reishi mushroom extract, by mouth, daily for the first month</li> <li class="seamTextUnorderedListItem">Placebo for Reishi mushroom extract, by mouth, daily for the second month</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for Reishi mushroom extract, by mouth, daily for the first month</li> <li class="seamTextUnorderedListItem">Reishi mushroom extract, by mouth, daily for the second month</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy commonly used to treat hormone receptor-positive breast cancer. The approved aromatase inhibitors are anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®).</li> <li class="seamTextUnorderedListItem">Side effects of aromatase inhibitors may include fatigue, joint pain, and/or muscle pain.</li> <li class="seamTextUnorderedListItem">Studies suggest that Reishi mushroom extract has beneficial effects including reducing fatigue.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06028022' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/aromatase-inhibitors' target='_blank'>Breastcancer.org: Aromatase Inhibitors and Pain</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancercare.org/questions/11' target='_blank'>Cancer Care: Aromatase Inhibitors and Fatigue</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healthline.com/nutrition/reishi-mushroom-benefits#TOC_TITLE_HDR_8' target='_blank'>Healthline: Reishi Mushroom Extract</a> </li></ul>
49
NEAREST SITE: 1481 miles
South Texas Accelerated Research Therapeutics (START)
San Antonio,TX
VISITS: At least 3 visits within 3 months
PHASE: II
NCT ID: NCT06465368
PF-07220060 CDK4 Inhibitor with Hormone Therapy for Postmenopausal Women Newly Diagnosed with Stage I-III HR+, HER2- Breast Cancer
AN INTERVENTIONAL, OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 2 STUDY OF PF-07220060 PLUS LETROZOLE COMPARED TO LETROZOLE ALONE IN POSTMENOPAUSAL WOMEN 18 YEARS OR OLDER WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE BREAST CANCER IN THE NEOADJUVANT SETTING Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of PF-07220060, an experimental CDK4 inhibitor, with letrozole (Femara®) hormone therapy compared to letrozole (Femara®) alone.
Who is this for?
Postmenopausal women with newly diagnosed stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060, by mouth, daily for 2 weeks</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 weeks</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily for 2 weeks</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-07220060 is an experimental targeted therapy called a <span class="highlight">CDK4</span> inhibitor. <span class="highlight">CDK4</span> inhibitors block the enzyme <span class="highlight">CDK4</span> that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. Aromatase inhibitors block production of estrogen that helps cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06465368' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/find-a-trial/nct06465368-breast-cancer-trial' target='_blank'>Pfizer: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://cdn.pfizer.com/pfizercom/product-pipeline/Pipeline_Update_30JUL2024.pdf?VersionId=Rrp_poDG5KJY7k3yrU7movuv7fDRCIQU' target='_blank'>Pfizer: PF-07220060 Drug Information Page</a> </li></ul>
50
NEAREST SITE: 1509 miles
UT Southwestern Medical Center
Dallas,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05693766
Hormone Therapy or Chemotherapy with Genetic Testing for Metastatic HR+, HER2- Breast Cancer
Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT) Scientific Title
Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of hormone therapy and capecitabine (Xeloda®) chemotherapy and use MammaPrint® and BluePrint tests to guide treatment decisions.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-), non-Luminal A breast cancer who have received treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator (SERM/SERD) with a CDK4/6 inhibitor. You must not have received chemotherapy or more than 1 line of hormone therapy for advanced disease or have a PIK3CA mutation.
Full eligibility criteria
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- 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: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 1 week on, 1 week off</li> <li class="seamTextUnorderedListItem">Provide tissue samples for MammaPrint® and BluePrint tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">MammaPrint® and BluePrint are genetic tests that use tumor samples to help guide treatment decisions.</li> <li class="seamTextUnorderedListItem">The tests will also be used to determine if certain mutations are potentially associated with resistance to therapy.</li> <li class="seamTextUnorderedListItem">Luminal A breast cancer is ER+, PR+, and HER2- with low Ki-67 levels, which controls how fast cancer cells grow. Luminal A cancers tend to grow more slowly.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05693766' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/types/molecular-subtypes' target='_blank'>Breastcancer.org: Molecular Subtypes of Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/genetic-testing' target='_blank'>Breastcancer.org: Genetic Testing for Breast Cancer</a> </li></ul>
51
NEAREST SITE: 1509 miles
UTSW Medical Center
Dallas,TX
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 being studied?
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: CCNE1 Amplified Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: ER Positive, HER2 Negative Breast Cancer</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degrader (SERD) hormone therapy (standard of care)</li> <li class="seamTextUnorderedListItem"><span class="highlight">CDK</span> 4/6 inhibitor (standard of care)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315 is an experimental targeted therapy called a <span class="highlight">CDK2</span> inhibitor. <span class="highlight">CDK2</span> inhibitors block the enzyme/protein <span class="highlight">CDK2</span> 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, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CCNE1</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05735080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://incyclixbio.com/our-science/' target='_blank'>Incyclix Bio Drug Information Page: INX-315</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy and SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li></ul>
52
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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen. 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 <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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>
53
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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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-A51, by mouth, 5 days on, 2 days off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BTX-A51 is an experimental targeted therapy called a multi-kinase inhibitor that blocks CK1α and <span class="highlight">CDK7/9.</li></ul></span>
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<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>
54
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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). It is approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">A drug holiday is a planned period of time that you decide with your doctor to stop taking a medication. In some cases, a drug holiday can allow a medication to become effective again.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put you in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05305924' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/drug-holiday-definition-risks-and-benefits-2248870' target='_blank'>Verywell Health: Drug Holiday</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/pathology-report/hormone-receptor-status' target='_blank'>Breastcancer.org: Hormone Receptor Status</a> </li></ul>
55
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05700721
Niraparib and Dostarlimab for Metastatic Triple Negative or Mutated Breast Cancer with Brain Metastasis
Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of niraparib (Zejula®) PARP inhibitor with dostarlimab (Jemperli®) PD-1 inhibitor.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with a BRCA1, BRCA2, ATM, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51, RAD51B, RAD51C, RAD51D, RAD52, or RAD54L mutation that has spread to the brain (brain metastasis). You must have received at least one line of therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li> <li class="seamTextUnorderedListItem">Lumbar puncture (optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05700721' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
56
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?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421, by mouth</li> <li class="seamTextUnorderedListItem">Camizestrant, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), ribociclib (Kisqali®) and/or palbociclib (Ibrance®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8421 is an experimental type of targeted therapy called a <span class="highlight">CDK2</span> inhibitor. <span class="highlight">CDK2</span> inhibitors may block the enzyme <span class="highlight">CDK2</span> 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 <span class="highlight">CDK4/6</span> inhibitors. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06188520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazeneca.com/our-therapy-areas/pipeline.html' target='_blank'>AstraZeneca: AZD8421 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.aacr.org/about-the-aacr/newsroom/news-releases/camizestrant-may-be-superior-to-fulvestrant-in-patients-with-hormone-receptor-positive-her2-negative-breast-cancer/' target='_blank'>American Association for Cancer Research: Camizestrant</a> </li></ul>
57
NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO
VISITS: 9 visits within 6 months, then every 3 months for 2.5 years
PHASE: NA
NCT ID: NCT04968964
DiviTum Blood Test to Determine Additional Testing for People with Metastatic HR+, HER2- Breast Cancer
TK IMPACT: Treatment Monitoring of Patients Receiving CDK 4/6 Inhibitors for Hormone Receptor (HR) Positive, HER2 Negative Metastatic Breast Cancer (MBC) With or Without the Addition of DiviTum® Serum Thymidine Kinase 1 (TK1) Activity Testing: Physician Decision Impact Study Scientific Title
Purpose
To study whether the DiviTum® blood test affects your doctor's decision to conduct additional tumor tests or imaging.
Who is this for?
People with metastatic (stage IV) hormone positive (HR+), HER2 negative (HER2-) breast cancer receiving or planning to receive their first line of therapy for metastatic disease with hormone therapy and a CDK 4/6 inhibitor at Washington University School of Medicine Siteman Cancer Center.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests, every 2-4 weeks for 6 months, then every 3 months for 2.5 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The DiviTum® TKa test measures TK1 activity in your blood, which may indicate the rate your cancer is growing and the need for additional tests.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04968964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://biovica.com/divitum/' target='_blank'>Biovica: DiviTum® Test</a> </li></ul>
58
NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO
VISITS: At least 4 visits within 4 months
PHASE: NA
NCT ID: NCT05977036
Biomarker Test to Change or Continue Treatment for Advanced HR+, HER2- Breast Cancer
BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer Scientific Title
Purpose
To use the DiviTum® TKa blood test to determine if people with advanced HR+, HER2- breast cancer should continue or switch treatments.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have not yet received treatment for advanced disease. You must be planning to receive hormone therapy with a CDK4/6 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups depending on results of the DiviTum® TKa blood tests: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Suppressed (Low) TKa Levels</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test, 4 times within 4 months</li> <li class="seamTextUnorderedListItem">Continue on endocrine therapy and <span class="highlight">CDK4/6</span> inhibitor (i.e., Ribociclib)</li> <li class="seamTextUnorderedListItem">Imaging scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Unsuppressed (Not Low) TKa Levels</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test, 4 times within 4 months</li> <li class="seamTextUnorderedListItem">Switch treatment</li> <li class="seamTextUnorderedListItem">Imaging scans</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum® TKa blood test is a blood test that measures thymidine kinase activity (TKa) which may predict how well tumors respond to treatment.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05977036' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://biovica.com/divitum/' target='_blank'>Biovica: DiviTum® Test</a> </li></ul>
59
NEAREST SITE: 1739 miles
Washington University School of Medicine
Saint Louis,MO
VISITS: Weekly for 3 weeks, then 1 visit every 3 weeks
PHASE: I-II
NCT ID: NCT06374459
Zunsemetinib Targeted Therapy with Chemotherapy for Metastatic HR+, HER2- Breast Cancer with Bone Metastasis
A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of zunsemetinib, an experimental targeted therapy, with chemotherapy compared to standard of care.
Who is this for?
People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has spread to the bone (bone metastasis). You must have received 1 line of hormone therapy with a CDK4/6 inhibitor and no more than 1 line of chemotherapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) or denosumab, every 1-3 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zunsemetinib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zunsemetinib is an experimental targeted therapy called an MK2 inhibitor. Blocking MK2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Zunsemetinib targets a molecule that may play a role in inflammation and bone loss.</li> <li class="seamTextUnorderedListItem">Bisphosphonate (zoledronic acid) and denosumab are standard of care drugs that help strengthen bones but have little effect on pain relief and anti-cancer activity.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06374459' target='_blank'>ClinicalTrials.gov</a> </li></ul>
60
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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<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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<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>
61
NEAREST SITE: 2136 miles
Grady Health System
Atlanta,GA
VISITS: Up to 1-2 visits every week for 3 months
PHASE: NA
NCT ID: NCT06534125
Acupuncture or Acupressure to Prevent Joint Pain from Hormone Therapy for Postmenopausal Non-Hispanic Black Women with Stage I-III HR+, HER2- Breast Cancer
Preventing Aromatase Inhibitor-Associated Arthralgias Among Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer Scientific Title
Purpose
To compare the ability of in-person acupuncture and at-home acupressure to prevent joint pain from hormone therapy.
Who is this for?
Postmenopausal non-Hispanic Black women with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who completed treatment at least 2 weeks ago and are planning to receive letrozole (Femara®), anastrozole (Arimidex®), or exemestane (Aromasin®) aromatase inhibitor. You must not have received or be currently receiving palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) CDK4/6 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupuncture, in person, every 1-2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Surveys</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Acupressure, at home, every 1-2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Surveys</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">No acupuncture or acupressure</li> <li class="seamTextUnorderedListItem">Surveys</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitors prolong life in postmenopausal women with HR+ breast cancer.</li> <li class="seamTextUnorderedListItem">However, non-Hispanic Black women are more likely to experience side effects such as joint pain and stop their hormone therapy compared to non-Hispanic white women.</li> <li class="seamTextUnorderedListItem">Acupuncture involves inserting thin needles through the skin at specific points on the body to control pain.</li> <li class="seamTextUnorderedListItem">Acupressure uses the application of pressure or localized massage to specific sites on the body to control symptoms such as pain.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06534125' target='_blank'>ClinicalTrials.gov</a> </li></ul>
62
NEAREST SITE: 2299 miles
Roswell Park Cancer Institute
Buffalo,NY
VISITS: Number of visits unavailable
PHASE: NA
NCT ID: NCT04526587
Studying Response to Treatment With CDK 4/6 Inhibitors in People with Stage I-IV HR+, HER2- Breast Cancer
The Roswell Park Ciclib Study: A Prospective Study of Biomarkers and Clinical Features of Advanced/Metastatic Breast Cancer Treated With CDK4/6 Inhibitors Scientific Title
Purpose
To study how breast cancer develops resistance to treatment with CDK 4/6 inhibitors and how to predict response to treatment with CDK 4/6 inhibitors.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer or people with stage I, stage II, or stage III hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) node positive breast cancer. You must have completed treatment with or currently be receiving treatment with a CDK 4/6 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood, tissue, fluid, and biopsy samples</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your samples may be used to help your doctor make treatment decisions.</li> <li class="seamTextUnorderedListItem">Node positive breast cancer is breast cancer that has spread to the lymph nodes.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04526587' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK 4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/?utm_medium=email&utm_source=subscribers&utm_campaign=Dec2022&utm_content=Email122022' target='_blank'>Metastatic Trial Search: CDK Inhibitors</a> </li></ul>
63
NEAREST SITE: 2299 miles
Levine Cancer Institute
Charlotte,NC
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT06027268
Immunotherapy, Chemotherapy, and Targeted Therapy for Advanced Triple Negative Breast Cancer
ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of pembrolizumab (Keytruda®) PD-1 inhibitor, gemcitabine (Gemzar®) and carboplatin (Paraplatin®) chemotherapy, and trilaciclib (Cosela®) CDK4/6 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or ER low, PR- or PR low, HER2- or HER2 low) breast cancer. You must not have received more than 3 lines of chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela®) also helps protect the bone marrow from the side effects of chemotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06027268' target='_blank'>ClinicalTrials.gov</a> </li></ul>
64
NEAREST SITE: 2354 miles
Integrative Cardiovasculal Physiology Laboratory, University of Florida
Gainesville,FL
VISITS: At least 1 visit
PHASE: NA
NCT ID: NCT04914663
Exercise to Reduce Heart Problems During Chemotherapy for Women with Stage I-III Breast Cancer
All-extremity Exercise as a Novel Strategy for Optimizing Cardiovascular Function During Chemotherapy for Breast Cancer Scientific Title
Purpose
To study if 2 different types of exercise reduce heart problems during chemotherapy.
Who is this for?
Women with stage I, stage II, or stage III breast cancer who are planning to receive chemotherapy. You must not be receiving a CDK4/6 inhibitor, PARP inhibitor, or radiation during chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Full body exercise, at home, 3 months</li> <li class="seamTextUnorderedListItem">Physical function tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Treadmill exercise, at home, 3 months</li> <li class="seamTextUnorderedListItem">Physical function tests</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Usual Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Usual care</li> <li class="seamTextUnorderedListItem">Physical function tests</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancer treatments, such as chemotherapy, can cause or increase the risk of heart problems, which is called cardiotoxicity.</li> <li class="seamTextUnorderedListItem">Exercise may help reduce these heart problems.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04914663' target='_blank'>ClinicalTrials.gov</a> </li></ul>
65
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT04923542
Stereotactic Radiation, Abemaciclib, and Hormone Therapy for HR+, HER2- Breast Cancer Brain Metastases
Phase I/II Study of Stereotactic Radiation and Abemaciclib in the Management of Hormone Receptor Positive HER2 Negative Breast Cancer Brain Metastases Scientific Title
Purpose
To study the anti-cancer activity and side effects of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®), hormone therapy, and stereotactic radiation therapy together to treat brain metastases.
Who is this for?
People with metastatic (stage IV) hormone receptor-positive, HER2 negative (HER2-) breast cancer that has spread to the brain.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Doctor's choice of anti-estrogen therapy, ongoing</li> <li class="seamTextUnorderedListItem">Stereotactic Radiation Therapy to each brain met</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor -- it blocks two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. This stops cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Anti-estrogen therapies are commonly used to treat hormone receptor-positive breast cancer. These drugs are also called endocrine or hormone therapy and include tamoxifen, aromatase inhibitors, fulvestrant, and others. </li> <li class="seamTextUnorderedListItem">The hormone therapies used in this trial are fulvestrant and aromatase inhibitors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04923542' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/?s=brain+mets' target='_blank'>Metastatic Trial Talk: Topics for Breast Cancer Brain Mets</a> </li></ul>
66
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: Number of visits unavailable
PHASE: I
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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<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>
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<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 <span class="highlight">CDK4/6</span> inhibitors.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/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>
67
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: Weekly for 2 months then monthly for 3 months
PHASE: I
NCT ID: NCT06691035
Dendritic Cell Vaccine and Hormone Therapy for Metastatic HR+, HER2- Breast Cancer with ESR1 Mutations
Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of an experimental dendritic cell vaccine with elacestrant (Orserdu®) hormone therapy.
Who is this for?
People with metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 negative (HER2- or HER2 low) breast cancer with ESR1 mutations. You must have received a CDK4/6 inhibitor with hormone therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 2 months then monthly for 3 months</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after cancer cells with ESR1 mutations, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2/ISH-.</li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06691035' target='_blank'>ClinicalTrials.gov</a> </li></ul>
68
NEAREST SITE: 2453 miles
Johns Hopkins University
Baltimore,MD
VISITS: 2 visits in the first month; visits every 3-4 months while on treatment
PHASE: II
NCT ID: NCT03439735
Predicting Response to Treatment with an Aromatase Inhibitor and Palbociclib for Advanced HR+ Breast Cancer
Prospective Evaluation of Determinants of Resistance to First-line Therapy With an Aromatase Inhibitor and the Cyclin-dependent Kinases 4 and 6 Inhibitor Palbociclib in Hormone Receptor Positive Metastatic Breast Cancer Scientific Title
Purpose
To see if certain blood and tumor tests can help researchers predict which tumors will respond to an aromatase inhibitor and palbociclib (Ibrance®).
Who is this for?
People with newly diagnosed advanced (some stage III) and metastatic (stage IV), hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who will be treated with an aromatase inhibitor and palbociclib (Ibrance®).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws: at the start of treatment, at 1 month, and then every 3-4 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The researchers will analyze tumor tissue and blood samples during treatment. </li> <li class="seamTextUnorderedListItem">They will be looking specifically at a mutation, called ESR1, that can develop in cancer cells. </li> <li class="seamTextUnorderedListItem">Previous studies have suggested that cancer cells with this mutation may be less likely to respond to an aromatase inhibitor. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. It is approved for use in people with metastatic hormone positive, HER2 negative breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03439735' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ibrance.com/?src_code=IBRW10028851' target='_blank'>Pfizer Oncology Information Page: Ibrance</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/clinical-challenges/sabcs-breast-cancer/76896' target='_blank'>Medpage Today: What's Next for CDK4/6 Therapy?</a> </li></ul>
69
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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<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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<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>
70
NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ
VISITS: 1 visit every month
PHASE: I-II
NCT ID: NCT06110793
Targeted Therapy and Hormone Therapy for Advanced ER+ or ER Low, HER2- Breast Cancer
A Phase Ib/II Trial of Lenvatinib Plus Pembrolizumab Plus Fulvestrant in ER-positive/ HER2- Negative Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of lenvatinib (Lenvima®) tyrosine kinase inhibitor, pembrolizumab (Keytruda®) PD-1 inhibitor, and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) breast cancer who have received hormone therapy with a CDK4/6 inhibitor for advanced disease. You must not have received more than 2 lines of chemotherapy for advanced disease or a PD-1/PD-L1 inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by IV, monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Lenvatinib (Lenvima®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06110793' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a615015.html' target='_blank'>MedlinePlus: Lenvatinib (Lenvima®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
71
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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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06678269' target='_blank'>ClinicalTrials.gov</a> </li></ul>
72
NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,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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<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>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two proteins, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> 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>
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<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>
73
NEAREST SITE: 2567 miles
Weill Cornell Medicine
New York,NY
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04563507
Radiation Therapy, Anti-Estrogen Therapy, and a CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer
CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer Scientific Title
Purpose
To study the anti-cancer activity, side effects, and changes to ctDNA when giving radiation therapy before the standard of care hormone therapy and a CDK 4/6 inhibitor.
Who is this for?
Postmenopausal women with metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with no more than five metastases (mets).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, for 2 weeks</li> <li class="seamTextUnorderedListItem">followed by</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery) delivers focused radiation to each metastasis (met/tumor).</li> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is metastatic breast cancer with a small number of metastases.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04563507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/update-on-hormone-receptor-positive-mbc-2021/' target='_blank'>Metastatic Trial Talk: Update on Hormone Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/full/10.14694/EdBook_AM.2015.35.e8' target='_blank'>ASCO: Surgery or Ablative Radiotherapy for Breast Cancer Oligometastases</a> </li></ul>
74
NEAREST SITE: 2568 miles
Mount Sinai - West
New York,NY
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05095207
Abemaciclib With Bicalutamide for Androgen Receptor+, HER2- Advanced Breast Cancer
A Multicenter, Phase IB/II Study of Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) together with bicalutamide (Casodex®), an anti-androgen drug.
Who is this for?
Postmenopausal women with advanced (some stage III) or metastatic (stage IV) androgen receptor positive (AR+) HER2 negative breast cancer. You must have received at least one line of therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor -- it blocks two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-androgen drug used to treat prostate cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>
75
NEAREST SITE: 2582 miles
Smilow Cancer Hospital Care Center at Greenwich
Greenwich,CT
VISITS: 1-3 visits every month for up to 1 year
PHASE: NA
NCT ID: NCT06572800
Blood Test to Identify CDK4/6 Inhibitor Levels in Blood for Women with Metastatic ER+, HER2- or HER2 Low Breast Cancer
Use of DiviTum-TKa as a Biomarker Assay for CDK4/6 Inhibitor Medication Compliance and Drug-Drug Interaction Assessment in ER/PR Positive Metastatic Breast Cancer Scientific Title
Purpose
To study if the DiviTum-TKa blood test can identify and optimize levels of CDK4/6 inhibitors in the blood, help improve taking medication as prescribed, and remove potential drug-drug interactions.
Who is this for?
Women newly diagnosed with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2- or HER2 low) breast cancer who are planning to receive a CDK4/6 inhibitor with hormone therapy as their first line of therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DiviTum-TKa blood tests, 1-3 times every month for up to 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A <span class="highlight">CDK4/6</span> inhibitor with hormone therapy is the first line of therapy for people with metastatic hormone receptor positive (HR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Thymidine kinase is a biomarker (biological molecule found in blood, other body fluids, or tissues that is a sign of a condition or disease) that reflects cell proliferation (an increase in the number of cells as a result of cell growth and cell division).</li> <li class="seamTextUnorderedListItem">DiviTum-thymidine kinase activity (TKa) is an FDA approved blood test.</li> <li class="seamTextUnorderedListItem">The DiviTum-TKa blood test shows that TKa levels are associated with a lower risk of disease progression within 1-2 months of the blood test.</li> <li class="seamTextUnorderedListItem">Using the DiviTum-TKa blood test may improve taking medication as prescribed and remove potential drug-drug interactions.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is IHC 1+ or IHC 2+/FISH-.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06572800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://divitum.com/' target='_blank'>Biovica: DiviTum-TKa Information Page</a> </li></ul>
76
NEAREST SITE: 2587 miles
Miami Cancer Institute at Baptist Health, Inc.
Miami,FL
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT06263543
Sacituzumab Govitecan ADC After T-DXd ADC for Advanced HR+, HER2 Low Breast Cancer
SERIES: SEquencing Sacituzumab Govitecan AfteR T-DXd In ER+/HER2 LOW MetaStatic Breast Cancer Scientific Title
Purpose
To study if sacituzumab govitecan (SG, Trodelvy®) is still effective at the currently approved dose and schedule for people with advanced HR+, HER2 low breast cancer who have already received trastuzumab deruxtecan (T-DXd, Enhertu®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ or ER low and/or PR+ or PR low), HER2 low breast cancer who have received treatment with hormone therapy, CDK4/6 inhibitor, trastuzumab deruxtecan (T-DXd, Enhertu®), and 1-4 lines of chemotherapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (SG, Trodelvy®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Although Sacituzumab govitecan (SG, Trodelvy®) is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if it is still effective specifically in people who have already received T-DXd.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (SG, Trodelvy®) is a type of targeted therapy called an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in sacituzumab govitecan (SG, Trodelvy®) targets TROP2 proteins. It delivers the chemotherapy irinotecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+/ISH- or IHC 1+/ISH- or ISH untested.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06263543' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/trodelvy' target='_blank'>Breastcancer.org: Sacituzumab Govitecan (SG, Trodelvy®)</a> </li></ul>
77
NEAREST SITE: 2591 miles
University of Miami
Miami,FL
VISITS: At least 1 visit every 2 months
PHASE: II
NCT ID: NCT05826964
ctDNA Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study Scientific Title
Purpose
To determine whether switching treatment earlier will increase the amount of time that metastatic breast cancer is controlled.
Who is this for?
People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: <span class="highlight">CDK4/6</span> inhibitor with aromatase inhibitor or <span class="highlight">CDK4/6</span> inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Early Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ctDNA test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: <span class="highlight">CDK4/6</span> inhibitor with aromatase inhibitor or <span class="highlight">CDK4/6</span> inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early switch to a new treatment, for 1 year 2 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used to indicate tumor biomarkers and the presence of circulating tumor (ctDNA).</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is define as IHC 1+ or 2+/FISH-.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) are types of targeted therapy called <span class="highlight">CDK4/6</span> inhibitors. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are premenopausal, you must also take a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05826964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>
78
NEAREST SITE: 2591 miles
University of Miami
Miami,FL
VISITS: At least 4 visits within 1 year
PHASE: NA
NCT ID: NCT06123988
Fasting and/or Exercise to Reduce Fatigue During Hormone Therapy for Women with Metastatic HR+ Breast Cancer
Prolonged Overnight Fasting And/or Exercise on Fatigue and Other Patient Reported Outcomes in Women with Hormone Receptor Positive Advanced Breast Cancer (FastER) Scientific Title
Purpose
To study the ability of fasting and/or exercise to reduce fatigue and improve other outcomes for women with advanced breast cancer who are receiving hormone therapy.
Who is this for?
Women with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) breast cancer who are planning to receive treatment (starting within 1 month) with a CDK4/6 inhibitor as the first or second line of hormone therapy for metastatic disease. You must not exercise more than 1.5 hours/week or participate in regular structured fasting.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Fasting Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting diet, daily for 3 months</li> <li class="seamTextUnorderedListItem">Complete food journal, daily for 3 months</li> <li class="seamTextUnorderedListItem">Heath coaching sessions, in-person or virtual, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Exercise Alone</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Exercise program with health coach, in-person or virtual, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Fasting and Exercise</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fasting diet, daily for 3 months</li> <li class="seamTextUnorderedListItem">Complete food journal, daily for 3 months</li> <li class="seamTextUnorderedListItem">Heath coaching sessions, in-person or virtual, weekly for 3 months</li> <li class="seamTextUnorderedListItem">Exercise program with health coach, in-person or virtual, 3 times every week for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4: No Fasting or Exercise</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">General health education sessions with health coach, virtual, every 2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Wear FitBit, daily for 3 months</li> <li class="seamTextUnorderedListItem">Blood and physical tests, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">PET and CT scans, 4 times in 1 year</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">If you are in Group 1 or Group 3, you will be asked to fast (not eat or drink) after 8pm, and wait 12 to 14 hours before eating and drinking the next day. You will be asked to fast 6 nights every week (1 night off every week).</li> <li class="seamTextUnorderedListItem">If you are in Group 4, the sessions focus on general nutrition, healthy lifestyle, and quality of life, with no discussion of fasting or exercise. </li> <li class="seamTextUnorderedListItem">This trial is also available in Spanish.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06123988' target='_blank'>ClinicalTrials.gov</a> </li></ul>
79
NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH
VISITS: 1 visit every month
PHASE: II
NCT ID: NCT05933395
Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.
Who is this for?
Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on biomarker testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK4/6</span> inhibitor. <span class="highlight">CDK4/6</span> inhibitors block two enzymes, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>
80
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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<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>
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<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>
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<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>
81
NEAREST SITE: 2693 miles
Massachusetts General Hospital
Boston,MA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT03285412
Additional Therapy after Standard Treatment for Women with Stage I-III, ER+, HER2- Breast Cancer with Residual Disease by ctDNA Testing
Phase II Study of CDK 4/6 Inhibitor, LEE011 (Ribociclib), in Combination With Adjuvant Endocrine Therapy at Varying Duration for ER-positive Breast Cancer (LEADER) Scientific Title
Purpose
To study the anti-cancer activity, safety, and side effects of giving additional treatment with a CDK 4/6 inhibitor to treat residual disease defined as testing positive for ctDNA.
Who is this for?
Women with stage I, stage II, or stage III estrogen receptor-positive (ER+), HER2 negative (HER2-) breast cancer who have completed treatment (other than hormone therapy) for breast cancer and test positive for detectable disease with a ctDNA test. You will be given a blood test to look for ctDNA. You may enroll in this trial up to ten years after diagnosis.
Full eligibility criteria
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<p class="seamTextPara"> If your ctDNA test comes back positive for residual disease, you will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of hormone therapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">Researchers are studying if a test looking for ctDNA in the bloodstream can determine if there will be a recurrence (coming back) of a women's breast cancer.</li> <li class="seamTextUnorderedListItem">The ctDNA blood test used in this trial is called Signatera.</li> <li class="seamTextUnorderedListItem">This trial is also studying if a recurrence can be stopped or delayed by giving women with a positive ctDNA test additional treatment.</li> <li class="seamTextUnorderedListItem">The additional treatment in this trial includes Ribociclib (Kisqali®).</li> <li class="seamTextUnorderedListItem">Palbociclib is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer, but its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03285412' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.natera.com/oncology/signatera-advanced-cancer-detection/' target='_blank'>Natera ctDNA Test Information Page: Signature</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/testing/circulatingtumordna/' target='_blank'>What is Circulating Tumor DNA and How is it Used to Diagnose and Manage Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2021/a-tale-of-two-cdk46-inhibitors-in-early-breast-cancer/' target='_blank'>The ASCO Post: A Tale of Two CDK4/6 Inhibitors in Early Breast Cancer</a> </li></ul>
82
NEAREST SITE: 2693 miles
Dana Farber Cancer Institite
Boston,MA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05608252
VS-6766 Targeted Therapy for Advanced HR+, HER2- Breast Cancer
A Single Arm Phase 1/2 Trial of Abemaciclib + VS-6766 + Fulvestrant in Metastatic HR+/HER2- Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of VS-6766, an experimental RAF/MEK inhibitor, with abemaciclib (Verzenio®) CDK 4/6 inhibitor and fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. You must have received treatment with fulvestrant (Faslodex)® for advanced/metastatic disease and a CDK 4/6 inhibitor after surgery (adjuvant) or for advanced/metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VS-6766 is an experimental targeted therapy called a RAF/MEK inhibitor that targets and interrupts a pathway that allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a <span class="highlight">CDK</span> 4/6 inhibitor. <span class="highlight">CDK</span> 4/6 inhibitors block two proteins, <span class="highlight">CDK4</span> and <span class="highlight">CDK6,</span> that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal women and men will also be given a drug that will put women in temporary menopause.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05608252' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verastem.com/research/pipeline/#raf-mek-inhibition' target='_blank'>Verastem: VS-6766 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
