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Treatment

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BRCA1/2 (inherited)

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PIK3CA or PI3K

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RAF (including BRAF)

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ROS1

TP53

No travel requiredTrials coming soon to MTSAdditional metastatic cancer trials

1

NEAREST SITE: 0 miles
M D Anderson Cancer Center
Houston, TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03207529

Alpelisib & Enzalutamide in Advanced HER2 Negative Breast Cancer That Tests Positive for AR and PTEN

Phase Ib Study of BYL719 (Alpelisib) in Combination With Androgen Receptor Inhibitor (Enzalutamide) in Patients With Androgen Receptor (AR)-Positive and PTEN Positive Metastatic Breast Cancer Scientific Title

Purpose
To determine the best dose, safety, and effects (good and bad) of alpelisib (Piqray®) when it is used along with enzalutamide (Xtandi®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer that tests AR-positive and PTEN-positive and who have received at least one standard therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Piqray is a targeted therapy that inhibits PI3K. It is approved to treat advanced hormone receptor positive, HER2 negative breast cancer in patients with a tumor that has a PIK3CA mutation. </li> <li class="seamTextUnorderedListItem">Xtandi is an oral drug that targets the <span class="highlight">androgen</span> receptor (AR). It is approved to treat advanced prostate cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AR (<span class="highlight">androgen</span> receptor), PTEN</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03207529' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hcp.novartis.com/products/piqray/metastatic-breast-cancer/?site=PIQ-1221443GK100070&source=01030&gclid=CjwKCAjwqML6BRAHEiwAdquMndS0YjjO837gyodgP7mwwUOT5tESFIWm4OnegRTdcPJWR25nfOu0ohoCTgAQAvD_BwE&gclsrc=aw.ds' target='_blank'>Novartis Drug Information Page: Piqray® (Alpelisib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/enzalutamide' target='_blank'>NCI Drug Dictionary: Enzalutamide</a> </li></ul>
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2

NEAREST SITE: 0 miles
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati, OH

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT05065411

Enobosarm With Abemaciclib for Metastatic AR+, ER+, HER2- Breast Cancer

P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of enobosarm, an experimental type of hormone therapy called a SARM, with abemaciclib (Verzenio®), a type of targeted therapy called a CDK 4/6 inhibitor, compared to standard hormone treatment.
Who is this for?
People with metastatic (stage IV), androgen receptor positive (AR+), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that has progressed on hormone therapy plus palbociclib (Ibrance®).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enobosarm, by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aromatase inhibitor, or fulvestrant (Faslodex®), by injection, monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enobosarm is an experimental type of hormone therapy called a selective <span class="highlight">androgen</span> receptor modulator (SARM) that targets the <span class="highlight">androgen</span> receptor (AR).</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK4/6 inhibitors block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are a type of hormone therapy that 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 downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Mutations or targets: AR</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05065411' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://verupharma.com/pipeline/enobosarm-for-breast-cancer/' target='_blank'>Veru Pharma Drug Information Page: Enobosarm</a> </li><li class='seamTextUnorderedListItem'><a href='https://verupharma.com/pipeline/enobosarm-abemaciclib-combination-therapy-for-breast-cancer/' target='_blank'>Veru Pharma Drug Information Page: Enobosarm + Abemaciclib Combination Therapy for Breast Cancer</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#section-types-of-hormonal-therapy' target='_blank'>Breastcancer.org: Aromatase Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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3

NEAREST SITE: 0 miles
Providence Oncology & Hematology Care Clinic - Eastside
Portland, OR

VISITS: 1 visit every 2 weeks

PHASE: II

NCT ID: NCT03650894

Nivolumab with Ipilimumab and Bicalutamide for Advanced HER2- Breast Cancer

A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer Scientific Title

Purpose
To test the safety and effects (good and bad) of using a combination of nivolumab (Opdivo®), ipilimumab (Yervoy®), and bicalutamide (Casodex®).
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, every 6 weeks</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Opdivo® is a type of immunotherapy that gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">Yervoy is an immunotherapy that works by blocking a protein called CTLA-4. </li> <li class="seamTextUnorderedListItem">Yervoy and Opdivo are approved to be used together to treat patients with melanoma and certain other cancers. Their use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Casodex is an anti-<span class="highlight">androgen</span> drug used to treat prostate cancer. </li> <li class="seamTextUnorderedListItem">Some breast cancers contain <span class="highlight">androgen</span> receptors. Laboratory studies suggest these tumors may respond to anti-<span class="highlight">androgen</span> therapies.</li> <li class="seamTextUnorderedListItem">Targets or mutations: If your tumor is triple negative (ER-, PR-, HER2-), it must test positive for <span class="highlight">androgen</span> receptors (AR)</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03650894' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ipilimumab' target='_blank'>NCI drug dictionary: Ipilimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/nivolumab' target='_blank'>NCI drug dictionary: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/bicalutamide' target='_blank'>NCI drug dictionary: Bicalutamide</a> </li></ul>
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4

NEAREST SITE: 0 miles
Mount Sinai Beth Israel
New York, NY

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05095207

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

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

Purpose
To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor abemaciclib (Verzenio®) together with bicalutamide (Casodex®), an anti-androgen drug.
Who is this for?
Postmenopausal women with advanced (some stage III) or metastatic (stage IV) androgen receptor positive (AR+) HER2 negative breast cancer. You must have received at least one line of therapy for advanced disease.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK 4/6 inhibitor -- it blocks two enzymes, CDK4 and CDK6, that help cancer grow. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li> <li class="seamTextUnorderedListItem">Bicalutamide (Casodex®) is an anti-<span class="highlight">androgen</span> drug used to treat prostate cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05095207' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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5

NEAREST SITE: 0 miles
Morton Plant Hospital/ BayCare Health System, Inc
Clearwater, FL

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04869943

Enobosarm for Androgen Receptor Positive (AR+), ER+, HER2- Metastatic Breast Cancer

Randomized Phase 3 Efficacy Evaluation of Enobosarm Monotherapy vs Control Treatment of AR+/ER+/HER2- MBC in Patients With AR Nuclei Staining ≥40% Who Has Shown Disease Progression on a Nonsteroidal AI Fulvestrant and CDK 4/6 Inhibitor. (ARTEST) Scientific Title

Purpose
To study the anti-cancer activity of Enobosarm, an experimental selective androgen receptor modulator (SARM).
Who is this for?
People with metastatic (stage IV) androgen receptor positive (AR+), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. Your tumor must have already been treated with fulvestrant (Faslodex®), an aromatase inhibitor, and a CDK 4/6 inhibitor.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will 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">Enobosarm, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estrogen receptor targeted therapy (standard of care at the clinical study site)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enobosarm is a selective <span class="highlight">androgen</span> receptor modulator (SARM) that targets the <span class="highlight">androgen</span> receptor (AR).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04869943' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/fda-grants-fast-track-designation-to-enobosarm-in-ar-er-her2--metastatic-breast-cancer' target='_blank'>Cancer Network: FDA Grants Fast Track Designation to Enobosarm in AR+, ER+, HER2- Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/enobosarm-generates-overdue-excitement-in-ar-er-metastatic-breast-cancer' target='_blank'>OncLive: Enobosarm Generates Overdue Excitement in AR+/ER+ Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/enobosarm' target='_blank'>Cancer.gov definition: Enobosarm</a> </li><li class='seamTextUnorderedListItem'><a href='https://verupharma.com/pipeline/enobosarm-abemaciclib-combination-therapy-for-breast-cancer/' target='_blank'>Sponsor (Veru Pharma) Drug Information page: Enobosarm</a> </li></ul>
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