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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.

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(Last updated: November 29, 2020)

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1

NEAREST SITE: 3 miles
University of California at San Francisco (PARENT)
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03734029

Trastuzumab Deruxtican (DS-8201a) for Advanced HER2 Low Expression Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [DESTINY-Breast04] Scientific Title

Purpose
To compare the safety, effects (good and bad), and anti-cancer activity of the targeted therapy trastuzumab deruxtican (DS-8201a) to the standard of care.
Who is this for?
People with advanced (stage III that cannot be removed by surgery) or metastatic (stage IV) HER2 low expression 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 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">Trastuzumab deruxtican (DS-8201a), by IV, every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">your doctor's choice of chemotherapy: capecitabine (Xeloda®), eribulin (Halaven®), gemcitabine (Gemzar®), paclitaxel (Taxol®), or nab-paclitaxel (Abraxane®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">HER2</span> <span class="highlight">low</span> expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (DS-8201a) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a chemotherapy directly to cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03734029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/clinical-trials/19-100' target='_blank'>Memorial Sloan Kettering Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab_deruxtecan' target='_blank'>Wikipedia: Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/10.1200/JCO.19.02488' target='_blank'>Journal Article: HER2-Low Breast Cancer: Pathological and Clinical Landscape</a> </li></ul>
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2

NEAREST SITE: 3 miles
University of California San Francisco Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04042701

Fam-Trastuzumab Deruxtican-nxki and Pembrolizumab for Advanced HER2 Positive and HER2 Low Expression Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC) Scientific Title

Purpose
To find the best dose and to study the safety, effects (good and bad), and anti-tumor activity of the targeted therapy fam-trastuzumab deruxtican-nxki (Enhertu®) when it is given in combination with the immunotherapy pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer whose cancer progressed after receiving trastuzumab emtansine (T-DM1) or standard of care 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">Fam-Trastuzumab Deruxtican-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">HER2</span> <span class="highlight">low</span> expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtican-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PD-1 allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042701' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer' target='_blank'>FDA: FDA Approves Fam-Trastuzumab Deruxtecan-nxki</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fam-trastuzumab-deruxtecan' target='_blank'>NCI Drug Dictionary: Fam-Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/february-2020/trastuzumab-deruxtecan-in-her2-low-expressing-previously-treated-advanced-breast-cancer/' target='_blank'>ASCO Post: Trastuzumab Deruxtecan in HER2–Low-Expressing, Previously Treated Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Pembrolizumab' target='_blank'>Wikipedia: Pembrolizumab</a> </li></ul>
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3

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT03971409

Avelumab With Binimetinib, Utomilumab, or PF-04518600 For Advanced Triple Negative & ER-Low Breast Cancer

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

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 ER-Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint 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 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>
  • <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 people with triple negative as well as ER-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>
  • <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: Utomilumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.arraybiopharma.com/our-science/our-pipeline/binimetinib' target='_blank'>Array Biopharma: BINIMETINIB</a> </li></ul>
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4

NEAREST SITE: 339 miles
UCLA - Medical Center
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03523572

Fam-Trastuzumab Deruxtican-nxki (Enhertu®) and Immunotherapy for Advanced HER2 Positive or HER2 Low Expression Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of fam-trastuzumab deruxtican-nxki (Enhertu®) when it is given in combination with an immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer whose cancer did not respond to standard therapies    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtican-nxki (Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtican-nxki (Enhertu®) is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. It is approved for use in some people with HER2+ breast cancer but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem"><span class="highlight">HER2</span> <span class="highlight">low</span> expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is approved to treat certain types of cancers but its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03523572' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/news/updated-analysis-ongoing-phase-trial-ds-8201-confirms-significant-benefit-her2-breast-cancer-patients-pretreated-ado-trastuzumab-emtansine/' target='_blank'>ADC Review: Trial Update of DS-8201</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/april-10-2018/potent-anti-her2-agents-on-the-horizon/' target='_blank'>ASCO: Potent Anti-HER2 Agents</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/' target='_blank'>ADC Review: What Are Antibody-Drug Conjugates?</a> </li></ul>
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5

NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute
Los Angeles,CA

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT04025216

CAR-T Immunotherapy for Metastatic Triple Negative & ER-Low, HER2- Breast Cancer that is TnMUC1-Positive

A Phase 1 Open-Label, Multi-Center First in Human Study of TnMUC1-Targeted Genetically-Modified Chimeric Antigen Receptor T Cells in Patients With Advanced TnMUC1-Positive Solid Tumors and Multiple Myeloma Scientific Title

Purpose
To study the safety, best dose, side effects (good and bad), and anti-cancer activity of a new CAR-T cell immunotherapy that targets cancer cells that test positive for MUC1.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for the antigen TnMUC1.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, once, before the CART-T immunotherapy is given</li> <li class="seamTextUnorderedListItem">CART-TnMUC1, by IV, once</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule. May require hospital stay.</i></p>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body. </li> <li class="seamTextUnorderedListItem">The CAR-T therapy being used in this study trains the immune system to attack MUC1-positive cancer cells. </li> <li class="seamTextUnorderedListItem">Before you have the CAR-T cell therapy, you will be given the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to prepare your immune system to receive the CAR-T cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers that test TnMUC1-positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TnMUC1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04025216' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/car-t-cell-therapy' target='_blank'>NCI Dictionary of Cancer Terms: CAR T-cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tmunity.com/pipeline' target='_blank'>Drug Company Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/MUC1' target='_blank'>Wikipedia: MUC1</a> </li></ul>
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6

NEAREST SITE: 339 miles
The Angeles Clinic and Research Institute
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03665285

NC318 for Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors Scientific Title

Purpose
To study the best dose, safety, and effects (good and bad) of an experimental cancer drug called NC318.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has low levels of the protein PD-L1 and who have no standard treatment options available.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NC318, by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i> </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 or 2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NC318 is designed to block a protein, called S15, that keeps the immune system from killing cancer cells. </li> <li class="seamTextUnorderedListItem">Blocking this protein could help the immune system see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03665285' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796496' target='_blank'>NCI Drug Dictionary: NC318</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.nextcure.com/pipeline/' target='_blank'>Drug Company Information Page: NC318</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808' target='_blank'>Mayo Clinic: Monoclonal Antibody Drugs for Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2018/03/monoclonal-antibody-therapy-cancer/' target='_blank'>Dana-Farber Cancer Institute: What is Monoclonal Antibody Therapy for Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/keytruda-faq/what-are-pd1-and-pdl1/' target='_blank'>Merk Oncology: What are PD-1 and PD-L1?</a> </li></ul>
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7

NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA

VISITS: 2-3 visits every month, ongoing

PHASE: I-II

NCT ID: NCT03853707

Ipatasertib, Carboplatin and Paclitaxel in Metastatic Triple Negative & ER-Low Breast Cancer

A Phase I/IB Study of Ipatasertib in Combination With Carboplatin or Carboplatin/Paclitaxel in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose
To determine the best dose of ipatasertib (GDC-0068) when it is used along with paraplatin (Carboplatin®) alone or with paraplatin (Carboplatin®) and paclitaxel (Taxol®).
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that has not responded to standard treatment options.    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: With Paclitaxel</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, once daily, ongoing</li> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, 2 or 3 times a month, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, 2 or 3 times a month, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Without Paclitaxel</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, once daily, ongoing</li> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, 2 or 3 times a month, ongoing</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Ipatasertib is an investigational targeted therapy that blocks a protein called AKT that helps cancer cells grow and divide. </li> <li class="seamTextUnorderedListItem">Carboplatin and Taxol are chemotherapy drugs used to treat breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03853707' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/News/57955' target='_blank'>ASCO Post: AKT Inhibitor Ipatasertib in Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2018/data-support-phase-3-trial-with-akt-inhibitor-in-triple-negative-breast-cancer' target='_blank'>OncLive: Early OS Data Support Phase III Trial With AKT Inhibitor Ipatasertib for TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdz133/5485241' target='_blank'>Annals of Oncology: Targeting the PI3-kinase pathway in triple-negative breast cancer</a> </li></ul>
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8

NEAREST SITE: 533 miles
OHSU Knight Cancer Institute
Portland,OR

VISITS: Monthly visits for 1 year

PHASE: II

NCT ID: NCT03801369

Olaparib and Durvalumab in Metastatic Triple Negative & ER-Low Breast Cancer

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

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 ER-Low (1%-10% ER) 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">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>
  • <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 people with triple negative as well as ER-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>
  • <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>
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9

NEAREST SITE: 538 miles
Providence Cancer Institute
Portland,OR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03602079

A166 for Advanced HER2 Positive and HER2 Low Expression Breast Cancer

A Phase I-II, FIH Study of A166 in Locally Advanced/Metastatic Solid Tumors Expressing Human Epidermal Growth Factor Receptor 2 (HER2) or Are HER2 Amplified That Did Not Respond or Stopped Responding to Approved Therapies Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of the experimental therapy A166.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer that has not responded to standard therapies    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A166, by IV </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A166 is a type of drug called an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">A166 combines chemotherapy with a HER2 targeted therapy, allowing it to deliver the chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem"><span class="highlight">HER2</span> <span class="highlight">low</span> expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03602079' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795827' target='_blank'>NCI Drug Dictionary: A166</a> </li></ul>
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10

NEAREST SITE: 671 miles
Banner MD Anderson Cancer Center
Gilbert,AZ

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03901469

ZEN003694 and Talazoparib for Triple Negative & ER-Low Breast Cancer

A Phase 2 Study of ZEN003694 in Combination With Talazoparib in Patients With Triple-Negative Breast Cancer Scientific Title

Purpose
To look at the safety and effects (good and bad) of using the experimental drug ZEN003694 along with talazoparib (Talzenna®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have been tested for and found to not have inherited a BRCA1 or BRCA2 mutation    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZEN003694, by mouth, once daily </li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, once daily</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">ZEN003694 is a drug taken by mouth that targets the protein BET. </li> <li class="seamTextUnorderedListItem">This protein helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">It prevents the PARP protein from repairing damaged DNA inside tumor cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat HER2-negative locally advanced or metastatic breast cancer in people with an inherited BRCA mutation.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03901469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-approves-talazoparib-for-brcamutated-her2negative-breast-cancer' target='_blank'>OncLive: FDA Approves Talazoparib for BRCA-Mutated, HER2-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/bet-bromodomain-inhibitor-zen-3694' target='_blank'>NCI Drug Dictionary: BET bromodomain inhibitor ZEN-3694</a> </li></ul>
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11

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

VISITS: 2-3 visits over 1-2 months; may include hospital stay

PHASE: I

NCT ID: NCT02706392

CAR T-Cell Therapy For Metastatic Triple Negative & ER-Low Breast Cancer that is ROR1 Positive

Phase I Study of Adoptive Immunotherapy for Advanced ROR1+ Malignancies With Defined Subsets of Autologous T Cells Engineered to Express a ROR1-Specific Chimeric Antigen Receptor Scientific Title

Purpose
To assess the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1.
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that has not responded to other treatment options and that tests positive for ROR1.    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">Leukapheresis (blood draw for the collection of cells) </li> <li class="seamTextUnorderedListItem">Chemotherapy (cyclophosphamide and fludarabine), 1 or 2 times over 3 weeks</li> <li class="seamTextUnorderedListItem">ROR1 CAR-T cells, by IV, 1 or 2 times over 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay may be required</i></p>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">CAR-T is a personalized immunotherapy made from a patient's white blood cells. </li> <li class="seamTextUnorderedListItem">The blood cells are removed from the patient and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. The cells are then infused back into the patient in the hospital. </li> <li class="seamTextUnorderedListItem">The CAR-T therapy being used in this study trains the immune system to attack ROR1-positive tumor cells. </li> <li class="seamTextUnorderedListItem">It is given along with the chemotherapy drugs fludarabine phosphate and cyclophosphamide. These drugs are given to deplete lymph cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of ROR1-positive metastatic tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02706392' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/sabcs-2018/cart-trial-triple-negative-breast-cancer-start-tnbc/article/819085/' target='_blank'>Cancer Therapy Advisor: CAR-T Trial for Triple-Negative Breast Cancer Under Way</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr. Susan Love Research Foundation: Chimeric Antigen Receptor T-Cell (CAR-T) Therap</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/26874851' target='_blank'>Pubmed: Expression of ROR1 has prognostic significance in triple negative breast cancer.</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abstracts2view.com/sabcs18/view.php?nu=SABCS18L_1227' target='_blank'>SABCS 2018 Abstract: Trial update (ROR1-CAR)</a> </li></ul>
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12

NEAREST SITE: 1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays,KS

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

A Registry for People with Triple Negative or ER-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) Scientific Title

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 ER-Low (1%-10% ER) breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <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>
  • <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 people with triple negative as well as ER-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>
  • <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>
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13

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: 1 visit per month, ongoing

PHASE: II

NCT ID: NCT03941730

Estradiol in Advanced Triple Negative & ER-Low Tumors that Test Positive for ER Beta

Therapeutic Targeting of ER Beta in Triple Negative Breast Cancer Scientific Title

Purpose
To study the effects (good and bad) of estradiol in the subset of triple negative and ER-Low tumors that test positive for ER beta.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer whose tumor tests positive for estrogen receptor beta (ER beta).    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 3 times a day</li> <li class="seamTextUnorderedListItem">2 biopsies (at the start of treatment and after 1 month)</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Early studies suggest that estradiol--a type of estrogen--slows the growth of tumors that are ER-beta positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ER beta</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03941730' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Estrogen_receptor_beta' target='_blank'>Wikipedia: Estrogen receptor beta</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/estradiol.html' target='_blank'>Drugs.com: Estradiol</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/centers-programs/cancer-research/research-programs/womens-cancer-program/breast-cancer-spore/research-projects/therapeutic-targeting-estrogen-receptor-beta-triple-negative-breast-cancer' target='_blank'>Mayo Clinic: Therapeutic Targeting Estrogen receptor-beta in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/30338035' target='_blank'>Journal Abstract: Estrogen receptor-beta is a potential target for TNBC</a> </li></ul>
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14

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: 1 visit every 2-3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03106415

Pembrolizumab and Binimetinib for Advanced Triple Negative or ER-Low, HER2 Negative Breast Cancer

Phase I/II Trial of Pembrolizumab in Combination With Binimetinib in Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer Scientific Title

Purpose
To study the safety and effectiveness of using an immunotherapy along with a targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER), HER2 negative (HER2-) breast cancer. You must have received no more than 3 prior therapies for metastatic disease.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda ®), by IV, once every 2-3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Binimetinib (MEK162), by mouth, daily, ongoing</li></ul>
  • <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 people with triple negative as well as ER-Low, HER2- breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">Keytruda® is currently approved to treat certain types cancers. </li> <li class="seamTextUnorderedListItem">Binimetinib (MEK162) is a type of targeted therapy called an MEK inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03106415' 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.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Binimetinib' target='_blank'>Wikipedia: Binimetinib</a> </li></ul>
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15

NEAREST SITE: 1615 miles
Mayo Clinic
Rochester,MN

VISITS: 2-4 visits per month for 7 months

PHASE: II

NCT ID: NCT02876302

Ruxolitinib and Chemo Before Surgery for Stage III or Stage IV Triple Negative Inflammatory Breast Cancer

Phase II Study Of Combination Ruxolitinib (INCB018424) With Preoperative Chemotherapy For Triple Negative Inflammatory Breast Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of using a new targeted therapy in combination with chemotherapy.
Who is this for?
People with stage III or stage IV (metastatic) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER), HER2- inflammatory breast cancer who have not yet had surgery or radiation therapy.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups and receive the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months </li> <li class="seamTextUnorderedListItem">followed by AC chemotherapy, by IV, every 2 weeks, for 4 months </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months </li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®), by mouth, daily, for 3 months </li> <li class="seamTextUnorderedListItem">followed by AC chemotherapy, by IV, every 2 weeks, for 4 months </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months </li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®), by mouth, daily, for 3 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy being used in this trial is ruxolitinib (Jakafi®). It is used to treat myelofibrosis, a disease of the bone marrow.</li> <li class="seamTextUnorderedListItem">Studies suggest ruxolitinib may make chemotherapy more effective.</li> <li class="seamTextUnorderedListItem">The chemotherapy drugs that will be used in this study are paclitaxel (Taxol®), doxorubicin (Adriamycin®) and cyclophosophamide (Cytoxan®). These are commonly used for people with breast cancer. </li> <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 people with triple negative as well as ER-Low breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02876302' 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/publications/dictionaries/cancer-terms/def/jakafi' target='_blank'>NCI Drug Dictionary: Jakafi</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.theibcnetwork.org' target='_blank'>The IBC Network Foundation</a> </li></ul>
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16

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT02411656

Pembrolizumab for Recurrent or Metastatic HER2 Negative Breast Cancer that is also Inflammatory, Hormone Negative, or Hormone Low Expressing

A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer Who Have Received Prior Chemotherapy With Clinical Response Scientific Title

Purpose
To look at the safety and effects (good and bad) of using pembrolizumab (Keytruda®).
Who is this for?
People with recurrent or metastatic (stage IV) HER2 negative breast cancer that is also inflammatory or hormone negative (ER- and PR-) or hormone low expressing (ER and/or PR 1%-10%).    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">For this trial, breast cancer that tests positive for 1%-10% estrogen or progesterone receptors is called hormone low expressing. </li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as HR low expressing breast cancer. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is an immunotherapy that helps the body's immune system slow or stop cancer cell growth by blocking a protein known as programmed cell death receptor-1 (PD-1).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02411656' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwy7vlBRACEiwAZvdx9jIPFQgWidLA-C5wT1MzjtITa1lJzO4axMQhgd1rro0RP5g40-abvxoCQlYQA' target='_blank'>Merck Drug Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pembrolizumab' target='_blank'>NCI Drug Dictionary: Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/Inflammatory-Breast-Cancer.html' target='_blank'>Susan G. Komen: Inflammatory Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/TripleNegativeBreastCancer.html' target='_blank'>Susan G. Komen: Triple Negative Breast Cancer</a> </li></ul>
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17

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02926690

OTS167PO: A Targeted Therapy for Advanced Triple Negative or ER-Low Breast Cancer

A Phase I Study of OTS167PO, a MELK Inhibitor, to Evaluate Safety, Tolerability and Pharmacokinetics in Patients With Advanced Breast Cancer and Dose-Expansion Study in Patients With Triple Negative Breast Cancer Scientific Title

Purpose
To determine the safety and effects (good and bad) of using the experimental targeted therapy OTS167PO.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast (ER-, PR-, HER2-) or ER-Low (1%-10%) breast cancer.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OTS167PO </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapy used in this trial is OTS167PO. It is a MELK inhibitor. </li> <li class="seamTextUnorderedListItem">It is an experimental therapy. This means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">Targets or mutations: MELK</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02926690' 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.oncotherapy.co.jp/en/research-development/drug-discovery-research/melk-inhibitor/' target='_blank'>Drug Company Information Page: OTS167</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/melk-inhibitor-ots167' target='_blank'>NCI Drug Dictionary: OTS167</a> </li></ul>
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18

NEAREST SITE: 1643 miles
MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03654547

TT-00420 For Advanced Triple Negative or ER-Low Breast Cancer

A Phase I, First-In-Human, Multicenter, Open-Label Study of TT-00420, Administered Orally in Adult Patients With Advanced Solid Tumors and Triple Negative Breast Cancers Scientific Title

Purpose
To study the best dose, safety, and effects (good and bad) of an investigational targeted therapy called TT-00420.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that has not responded to other treatments.    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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TT-00420, by mouth, once daily, ongoing</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">TT-00420 blocks the growth of the new blood vessels tumors need to grow and targets tumor inflammation.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03654547' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://abstracts.asco.org/239/AbstView_239_266885.html' target='_blank'>ASCO abstract: TT-00420</a> </li></ul>
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19

NEAREST SITE: 1643 miles
Houston Methodist Hospital
Houston,TX

VISITS: 5 visits a week, every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT02834403

L-NMMA plus Taxotere for Women with Advanced Triple Negative or ER-Low Breast Cancer

Clinical Phase Ib Trial of L-NMMA Plus Docetaxel in the Treatment of Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients Scientific Title

Purpose
To determine the best dose, safety and effects of L-NMMA when it is given with chemotherapy.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer. If you are stage III, you must have received at least 3 types of chemotherapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">L-NMMA, by IV, daily for 5 days, every 3 weeks</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, once every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draws</li> <li class="seamTextUnorderedListItem">Biopsies</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">L-NMMA targets the NOS (nitric oxide synthase) inhibitor.</li> <li class="seamTextUnorderedListItem">The chemotherapy being used is docetaxel (Taxotere®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02834403' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/77/13_Supplement/CT037' target='_blank'>AACR Abstract: L-NMMA</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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20

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 4 visits every 6 weeks, ongoing

PHASE: I

NCT ID: NCT03579472

M7824 and Halaven for Metastatic Triple Negative or ER-Low Breast Cancer

A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose
To find the best dose of M7824 to use with eribulin (Halaven).
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) 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: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M7824, by IV, weekly, for 3 out of every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Eribulin, by IV, weekly, for 4 out of every 6 weeks, ongoing</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">M7824 is an investigational immunotherapy drug. </li> <li class="seamTextUnorderedListItem">It gets immune cells to see cancer cells by blocking PD-L1 and TGF-beta. </li> <li class="seamTextUnorderedListItem">Halaven is used to treat patients who have already had at least two other anticancer medicines for their metastatic breast cancer and who have already been treated with an anthracycline and a taxane for either early or advanced breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03579472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/io-m7824/' target='_blank'>Immuno-Oncology News: M7824</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.halaven.com/metastatic-breast-cancer' target='_blank'>Drug Company Information Page: Halaven</a> </li></ul>
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21

NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03733119

ONC201 and Methionine-Restricted Diet in Patients With Advanced Triple Negative Breast Cancer

ONC201 With and Without Methionine-Restricted Diet in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose
To compare the safety and effects (good and bad) of a targeted therapy called ONC201 in patients who are or are not on a methionine-restricted (low-protein) diet.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) 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 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">ONC201, by mouth, once a week, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONC201, by mouth, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Methionine-Restricted Diet, 5 days a week, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ONC201 is an experimental targeted therapy that targets Akt/ERK and can lead to the death of a tumor cell. </li> <li class="seamTextUnorderedListItem">Methionine is an essential amino acid that is found in foods that contain protein. </li> <li class="seamTextUnorderedListItem">The researchers want to see if restricting the amount of methionine in a patient's diet affects how the cancer responds to the drug ONC201.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03733119' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2018/05/180508155031.htm' target='_blank'>ScienceDaily: ONC201 kills breast cancer cells in vitro by targeting mitochondria</a> </li><li class='seamTextUnorderedListItem'><a href='https://integrativeoncology-essentials.com/2014/07/kill-cancer-restricting-methionine-rich-foods/' target='_blank'>Integrative Oncology Essentials: Kill Cancer By Restricting Methionine-Rich Foods</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sciencedaily.com/releases/2018/03/180322140921.htm' target='_blank'>Science Daily: Methionine-restricted diet</a> </li></ul>
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22

NEAREST SITE: 1754 miles
Cancer Care Specialists of Central Illinois-Swansea
Swansea,IL

VISITS: 1 visit every 3 weeks, for up to 2 years

PHASE: II

NCT ID: NCT04024800

AE37 Vaccine and Immunotherapy Pembrolizumab in Metastatic Triple Negative or ER-Low Breast Cancer

A Phase II Clinical Trial of Pembrolizumab in Combination With the AE37 Peptide Vaccine in Patients With Metastatic Triple-Negative Breast Cancer (NSABP FB-14) Scientific Title

Purpose
To study the safety, best dose and effects (good and bad) of an AE37 peptide vaccine (AE37) when it is given along with the PD-1 inhibitor pembrolizumab (Keytruda®).
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) who have been treated with at least one line of 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">AE37 Peptide vaccine, by injection, once every 3 weeks, for 4 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda® ), by IV, once every 3 weeks, for up to 2 years</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The vaccine is a type of immunotherapy. It gets the immune cells to see and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to see and kill cancer cells by blocking a checkpoint called PD-1. It is approved to treat metastatic breast tumors that genomic testing has shown are microsatellite instability-high (MSI-H) or have a DNA mismatch repair deficiency (dMMR).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04024800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/news/pembrolizumab-and-chemotherapy-met-primary-endpoint-in-phase-iii-tnbc-trial' target='_blank'>Targeted Oncology: Pembrolizumab and Chemotherapy Met Primary Endpoint in Phase III TNBC Trial</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ae37-peptide-gm-csf-vaccine' target='_blank'>NCI Drug Dictionary: AE37 peptide</a> </li></ul>
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23

NEAREST SITE: 1857 miles
University of Chicago
Chicago,IL

VISITS: 1 visit a week, ongoing

PHASE: II

NCT ID: NCT02788981

Abraxane & Mifepristone in Advanced Triple Negative or ER-Low Breast Cancer that is Glucocorticoid Receptor Positive

A Randomized, Placebo-Controlled, Double-Blind, Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel, Abraxane®) With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer Scientific Title

Purpose
To determine the safety and effects (good and bad) of using chemotherapy in combination with the anti-progesterone therapy mifepristone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for glucocorticoid receptors.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on, 1 week off)</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The chemotherapy drug being used in this study is nab-paclitaxel (Abraxane®). It is approved to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: glucocorticoid receptors</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02788981' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3860283/' target='_blank'>Clinical Cancer Research: Glucocorticoid receptor antagonism for TNBC</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.abraxanepro.com' target='_blank'>Drug Company Information Page: Abraxane</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Mifepristone' target='_blank'>Wikipedia: Mifepristone</a> </li></ul>
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24

NEAREST SITE: 1946 miles
Indiana University
Indianapolis,IN

VISITS: 1 visit a week, ongoing

PHASE: II

NCT ID: NCT02755272

Keytruda with Chemotherapy for Metastatic Triple Negative or ER-Low Breast Cancer

A Randomized Phase II Clinical Trial Assessing the Efficacy and Safety of MK-3475 (Pembrolizumab) in Combination With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity of giving the PD-1 inhibitor pembrolizumab (Keytruda®) immunotherapy in combination with chemotherapy.
Who is this for?
Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10%) 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 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">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and gemcitabine (Gemzar®) by IV, once a week, 2 weeks on 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and gemcitabine (Gemzar®) by IV, once a week, 2 weeks on 1 week off</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02755272' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwy7vlBRACEiwAZvdx9jIPFQgWidLA-C5wT1MzjtITa1lJzO4axMQhgd1rro0RP5g40-abvxoCQlYQA' target='_blank'>Merck Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
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25

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: 3 visits a month

PHASE: NA

NCT ID: NCT04249167

Cryoablation, Immunotherapy, & Chemotherapy For Advanced Triple Negative & ER-Low Breast Cancer That Tests Positive For PD-L1

Cryoablation and Anti-PD-L1 Immunotherapy for Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose
To study the safety and effects (good and bad) of cryoablation followed by treatment with atezolizumab (Tecentriq®) and nab-paclitaxel (Abraxane®).
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer whose tumor tests positive for PD-L1.    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">Cryoablation of tumor</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li></ul>
  • <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 people with triple negative as well as ER-Low, HER2 negative breast cancer.</li> <li class="seamTextUnorderedListItem">Cryoablation uses extreme cold to kill cancer cells. </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. It works by blocking the PD-L1 (programmed death-ligand 1) protein.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is approved for use with the chemotherapy drug Abraxane® to treat advanced, triple-negative, PD-L1-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04249167' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20477447' target='_blank'>Mayo Clinic: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI Cancer Currents Blog: Atezolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Protein-bound_paclitaxel' target='_blank'>Wikipedia: Protein-bound Paclitaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2019/atezolizumab-for-triple-negative-breast-cancer/' target='_blank'>ASCO: Atezolizumab for PD-L1–Positive Locally Advanced or Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.frontiersin.org/articles/10.3389/fimmu.2019.02283/full' target='_blank'>Frontiers in Immunology: Cryoablation and Immunotherapy</a> </li></ul>
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26

NEAREST SITE: 2394 miles
Charleston Oncology
Charleston,SC

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04461600

Targeted Therapy AL101 for Advanced Triple Negative or ER-Low Breast Cancer that Tests Positive for Notch Activation

A Phase 2, Multi-center, Open-label, Single Arm Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer Scientific Title

Purpose
To study the safety and anti-cancer activity of the experimental targeted therapy AL101.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have had no more than three therapies for advanced or metastatic disease and whose tumor tests positive for a Notch pathway activation mutation.    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">AL101</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">AL101 is a type of experimental targeted therapy called a GSI (selective small molecule gamma secretase inhibitor).</li> <li class="seamTextUnorderedListItem">Notch activation will be determined by a Next Generation Sequencing (NGS) test as part of the study.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Notch activating mutation</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04461600' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ayalapharma.com/pipeline/investigational-therapies-al101-and-al102' target='_blank'>Ayala Pharmaceuticals Drug Information Page: AL101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hindawi.com/journals/jo/2019/8707053/' target='_blank'>Hindawi Journal of Oncology: Notch Signaling Activation as a Hallmark for Triple-Negative Breast Cancer Subtype</a> </li></ul>
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27

NEAREST SITE: 2567 miles
Mount Sinai Downtown
New York,NY

VISITS: Visits every 3 weeks

PHASE: II

NCT ID: NCT02531932

Carboplatin and Afinitor for Women with Metastatic Triple Negative or ER-Low Breast Cancer

A Multi-Centered Randomized Phase II Study Comparison of Single-Agent Carboplatin vs the Combination of Carboplatin and Everolimus for the Treatment of Advanced Triple-Negative Breast Cancer Scientific Title

Purpose
To compare the safety and effects (good and bad) of carboplatin and Afinitor to carboplatin alone.
Who is this for?
Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> Participants will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Intervention</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®), by IV, every 3 weeks</li></ul>
  • <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 people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Paraplatin (Carboplatin®) is a platinum-based chemotherapy drug used to treat metastatic breast cancer that has not responded to previous treatments. </li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02531932' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancernetwork.com/news/new-approaches-triple-negative-breast-cancer' target='_blank'>CancerNetwork: New Approaches for TNBC</a> </li></ul>
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28

NEAREST SITE: 2569 miles
Icahn School of Medicine at Mount Sinai
New York,NY

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03709446

Leflunomide in Previously Treated Metastatic Triple Negative & ER-Low Breast Cancer

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

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 ER-Low (1%-10% ER) breast cancer who have had no more than 2 chemotherapy drugs used to treat metastases.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leflunomide (Arava®), by mouth, daily</li></ul>
  • <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 breast cancer.</li> <li class="seamTextUnorderedListItem">Leflunomide (Arava®) is approved to treat certain adults with rheumatoid arthritis.</li></ul>
  • <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>
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29

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: 1 visit per week

PHASE: II

NCT ID: NCT04468061

Sacituzumab Govitecan with or without Pembrolizumab for Advanced Triple Negative or ER-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) Scientific Title

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 ER-Low (1%-10% ER), HER2 negative breast cancer that is PD-L1 negative, who have not yet started treatment 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">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>
  • <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 drug 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 positive for 1%-10% estrogen receptors is called ER-Low. This trial is enrolling people with triple negative as well as ER-Low, HER2 negative breast cancer.</li></ul>
  • <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>
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