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1

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or <span class="highlight">ER</span> Low Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)

Purpose: To look at the safety and effects (good and bad) of combining the immunotherapy drug avelumab (Bavencio®) with binimetinib, utomilumab, or PF-04518600.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) or <span class="highlight">ER</span> Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-04518600, by IV, every 2 weeks </li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Utomilumab, by IV, once a month</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as <span class="highlight">ER</span> Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bavencio is type of immunotherapy called a PD-L1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is targeted therapy that blocks MEK, which helps cancer cells grow. It is used to treat metastatic melanoma. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">PF-04518600 is an investigational immunotherapy that targets OX40, a protein found on immune cells that have interacted with cancer cells. </li> <li class="seamTextUnorderedListItem">Utomilumab is an investigational immunotherapy that targets the 4-1BB (CD-137) protein on certain immune cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03971409' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/avelumab' target='_blank'>NCI Drug Dictionary: Avelumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pf-04518600/' target='_blank'>Immuno-Oncology News: PF-04518600</a> </li><li class='seamTextUnorderedListItem'><a href='https://pfe-pfizercom-prod.s3.amazonaws.com/news/asco/Pfizer_IO_41BB_UtomilumabFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/binimetinib' target='_blank'>NCI Drug Dictionary: Binimetinib</a> </li></ul>
1

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative or <span class="highlight">ER</span> Low Breast Cancer

Innovative Combination Immunotherapy for Metastatic Triple Negative Breast Cancer (TNBC): A Multicenter, Multi-Arm Translational Breast Cancer Research Consortium Study (InCITe)
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Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

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Visits:
1 visit every 2 weeks, ongoing

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ClinicalTrials.gov: NCT03971409

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Phase II

2

Olaparib and Durvalumab in Metastatic Triple Negative & <span class="highlight">ER</span> Low Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer

Purpose: To evaluate the safety and effects (good and bad) of using the combination of olaparib (Lynparza®) and durvalumab (Imfinzi®).

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or <span class="highlight">ER</span> Low (1%-10% ER) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily for 1 month, then once a month for 1 year</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly, for 1 year</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2-3 tumor biopsies</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as <span class="highlight">ER</span> Low breast cancer.</li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP). </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of ovarian cancer. </li> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy drug called a PD-L1 inhibitor. It gets the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of lung cancer. </li> <li class="seamTextUnorderedListItem">Preclinical studies suggest this drug combination may be effective in patients with metastatic triple negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03801369' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.imfinzi.com/stage-3-nsclc/about/how-imfinzi-works.html?source=imz_c_c_45&umedium=cpc&uadpub=google&ucampaign=2018imfinzidtcnsclcbranded_general&ucreative=branded_alone_ex&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>Durvalumab (Imfinzi®) Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com/ovarian-cancer/recurrent-ovarian-cancer.html?source=lyn_d_c_2&umedium=cpc&uadpub=google&ucampaign=lynparzadtcbranded_alone_2019&ucreative=branded_alone_ex&uplace=olapariblynparza&outcome=dtc&cmpid=1' target='_blank'>Olaparib (Lynparza®) Drug Information Page</a> </li></ul>
2

Olaparib and Durvalumab in Metastatic Triple Negative & <span class="highlight">ER</span> Low Breast Cancer

A Phase II, Open Label, Study of Olaparib and Durvalumab (MEDI4736) in Patients With Metastatic Triple Negative Breast Cancer
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Nearest Location:
533 miles
OHSU Knight Cancer Institute
Portland, OR

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Visits:
Monthly visits for 1 year

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ClinicalTrials.gov: NCT03801369

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Phase II

3

JAB-2485 Targeted Therapy for Advanced ER+, Triple Negative, or ARID1A Mutated Breast Cancer

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of JAB-2485, an experimental Aurora A inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) <span class="highlight">ER</span> <span class="highlight">positive</span> (ER+), triple negative (ER-, PR-, HER2-), or ARID1A mutated breast cancer who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485 is an experimental targeted therapy called an Aurora A inhibitor. Aurora A inhibitors may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ARID1A</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05490472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/aurora-a-kinase-inhibitor-jab-2485' target='_blank'>National Cancer Institute: JAB-2485</a> </li></ul>
3

JAB-2485 Targeted Therapy for Advanced ER+, Triple Negative, or ARID1A Mutated Breast Cancer

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors
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Nearest Location:
602 miles
University of Utah Huntsman Cancer Institute
Salt Lake City, UT

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05490472

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Phase I-II

4

A Registry for People with Triple Negative or <span class="highlight">ER</span> Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT)

Purpose: To learn more about the relationship between genetic mutations and cancer outcomes.

Who is this for?: People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or <span class="highlight">ER</span> Low (1%-10% ER) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> This is a data collection (registry) study. You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as <span class="highlight">ER</span> Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</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://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>
4

A Registry for People with Triple Negative or <span class="highlight">ER</span> Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT)
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Nearest Location:
1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, KS

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Visits:
1 visit

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ClinicalTrials.gov: NCT02302742

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Phase NA

5

Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or <span class="highlight">ER</span> Low Breast Cancer

Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer

Purpose: To study the anti-cancer activity, safety, and side effects of first giving bortezomib (Velcade®), then giving pembrolizumab (Keytruda®) and cisplatin (Platinol®).

Who is this for?: Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or <span class="highlight">ER</span> Low (1%-10% ER) breast cancer who have not received more than three chemotherapies for metastatic disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®), by IV</li> <li class="seamTextUnorderedListItem">followed by, pembrolizumab (Keytruda®) and cisplatin (Platinol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule.</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as <span class="highlight">ER</span> Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®) is a type of targeted therapy called a protease inhibitor. It is approved for use in some other cancers but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved for use in some cancers but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy commonly used for metastatic triple negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04265872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Bortezomib' target='_blank'>Wikipedia: Bortezomib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.velcade.com/about-velcade/faq' target='_blank'>Takeda Pharmaceutical Company Drug Information Page: Velcade® (Bortezomib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/86804' target='_blank'>MedPage Today: Pembrolizumab May Help in Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncobites.blog/2020/02/07/cisplatin-a-journey-to-a-solution-for-triple-negative-breast-cancer/' target='_blank'>OncoBites Blog: Cisplatin--A Journey to a Solution for Triple-Negative Breast Cancer</a> </li></ul>
5

Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or <span class="highlight">ER</span> Low Breast Cancer

Pilot Clinical Trial of Treatment With Bortezomib to Inhibit Homologous Recombination (HR) Followed by Pembrolizumab and Cisplatin in Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer
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Nearest Location:
1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, TX

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Visits:
Number of visits unavailable, ongoing

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ClinicalTrials.gov: NCT04265872

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Phase NA

6

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or <span class="highlight">ER</span> Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)

Purpose: To study the safety and anti-cancer activity of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy) alone and in combination with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-. HER2-) or <span class="highlight">ER</span> Low (1%-10% ER), HER2 negative breast cancer that is PD-L1 negative, who have not yet started treatment for metastatic disease. View full eligibility criteria

What's involved?

<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">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan (Trodelvy), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved for use in people with metastatic triple negative breast cancer who have already received at least two other therapies for metastatic disease. But its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low. This trial is enrolling people with triple negative as well as <span class="highlight">ER</span> Low, HER2 negative breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04468061' target='_blank'>ClinicalTrials.gov</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://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-sacituzumab-govitecan-triple-negative-breast-cancer' target='_blank'>NCI Cancer Currents Blog: Sacituzumab Govitecan Approved for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/dosing' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/pembrolizumab' target='_blank'>Cancer Research UK: Pembrolizumab (Keytruda)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/lab-tests/pdl1-immunotherapy-tests/' target='_blank'>NIH MedlinePlus: PDL1 (Immunotherapy) Tests</a> </li></ul>
6

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or <span class="highlight">ER</span> Low, HER2- Breast Cancer

Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)
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Nearest Location:
1857 miles
University of Chicago Medical Center
Chicago, IL

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Visits:
2 visits every 3 weeks

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ClinicalTrials.gov: NCT04468061

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Phase II

7

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or <span class="highlight">ER</span> Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

Purpose: To study the safety and anti-cancer activity of giving radiation therapy with a PARP inhibitor and a PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) or <span class="highlight">ER</span> Low (1%-10% ER) breast cancer. You must not have received more than two systemic therapies for advanced disease and you must not have a BRCA 1/2 mutation (inherited or tumor). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV, every 3 weeks for 3 months, then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Radiation therapy, 3 times, during the first week of treatment</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low. This trial is enrolling people with triple-negative as well as <span class="highlight">ER</span> Low breast cancer. </li> <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. It is considered an experimental drug in this trial. </li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is an experimental PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">An experimental therapy is a drug approved by the FDA for studying in people in clinical trials. A drug may be FDA approved for use in one disease but still considered experimental for use in breast cancer. </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">Researchers believe that radiation therapy may also boost the immune system, which will help the immune system go after and kill cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04837209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/triple-negative-breast-cancer-treatment-symptoms-research' target='_blank'>BCRF: Triple-Negative Breast Cancer: Symptoms, Treatment, Research</a> </li></ul>
7

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or <span class="highlight">ER</span> Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)
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Nearest Location:
2433 miles
Sibley Memorial Hospital
Washington, DC

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Visits:
3 visits for the first week, then every 3 weeks for 3 months, then every 6 weeks, ongoing

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ClinicalTrials.gov: NCT04837209

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Phase II

8

Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or <span class="highlight">ER</span> Low, Androgen Receptor <span class="highlight">Positive</span> Breast Cancer

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER- or <span class="highlight">ER</span> low, PR- or <span class="highlight">PR</span> low, HER2-) or <span class="highlight">ER</span> low, androgen receptor <span class="highlight">positive</span> (AR+) breast cancer who have received 0-1 lines of chemotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is an anti-androgen hormone therapy approved for people with prostate cancer. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Mifepristone is an anti-progesterone hormone therapy. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), paclitaxel (Taxol®), capecitabine (Xeloda®), and eribulin (Halaven®) are standard of care chemotherapy medications used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">If you are in group 3, you may be able to switch to group 2 if your cancer progresses.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06099769' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>Medline Plus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
8

Enzalutamide Alone or With Mifepristone for Advanced Triple Negative or <span class="highlight">ER</span> Low, Androgen Receptor <span class="highlight">Positive</span> Breast Cancer

A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06099769

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Phase II

9

Leflunomide in Previously Treated Metastatic Triple Negative & <span class="highlight">ER</span> Low Breast Cancer

A Phase I/II Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers

Purpose: To determine the safety and effects (good and bad) of leflunomide (Arava®), an oral drug that blocks dihydroorotate dehydrogenase (DHODH).

Who is this for?: Women with metastatic (stage IV) triple negative (ER-,PR-,HER2-) or <span class="highlight">ER</span> Low (1%-10% ER) breast cancer who have had no more than 2 chemotherapies used to treat metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leflunomide (Arava®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests <span class="highlight">positive</span> for 1%-10% estrogen receptors is called <span class="highlight">ER</span> Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as <span class="highlight">ER</span> Low breast cancer.</li> <li class="seamTextUnorderedListItem">Leflunomide (Arava®) is approved to treat certain adults with rheumatoid arthritis.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03709446' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/leflunomide-oral-route/description/drg-20067158' target='_blank'>Mayo Clinic: Drugs and Supplements Leflunomide (Oral Route)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2017/12/171219092956.htm' target='_blank'>Science Daily:Arthritis drug could help treat advanced skin cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncologynurseadvisor.com/home/cancer-types/breast-cancer/immunosuppressor-inhibits-metabolic-pathway-in-breast-cancer-kills-cancer-cells/' target='_blank'>Oncology Nurse Advisor: Immunosuppressor Inhibits Metabolic Pathway in Breast Cancer, Kills Cancer Cells</a> </li></ul>
9

Leflunomide in Previously Treated Metastatic Triple Negative & <span class="highlight">ER</span> Low Breast Cancer

A Phase I/II Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers
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Nearest Location:
2567 miles
Mt Sinai Chelesa
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03709446

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Phase I-II

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