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(Last updated: April 03, 2020)

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1

NEAREST SITE: 3 miles
UCSF Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03454451

CPI-006 Alone or With CPI-444 or Keytruda in Advanced Triple Negative Breast Cancer

A Phase 1/1b Multicenter Study To Evaluate The Humanized Anti-CD73 Antibody, CPI-006, As A Single Agent, In Combination With CPI-444, And In Combination With Pembrolizumab In Adult Subjects With Advanced Cancers Scientific Title

Purpose
To test the safety and effects (good and bad) of CPI-006 when it is given alone or with CPI-444 or with pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other 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 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">CPI-444, by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006 is an investigational immunotherapy that gets the immune system to after cancer cells by targeting CD73. </li> <li class="seamTextUnorderedListItem">CPI-444 is an investigational immunotherapy that targets the adenosine-A2A receptor (ADORA2A) on immune cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a <span class="highlight">checkpoint</span> inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </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/NCT03454451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.2505' target='_blank'>Journal of Clinical Oncology: CPI-006, an anti-CD73 antibody with immune modulating activity, in a phase 1 trial in advanced cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/adenosine-a2a-receptor-antagonist-cpi-444' target='_blank'>NCI Drug Dictionary: adenosine-A2A receptor antagonist CPI-444</a> </li></ul>
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2

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

VISITS: Number of visits unavailable, over 4 months

PHASE: NA

NCT ID: NCT02872025

Pembrolizumab Before Surgery for Women With High-Risk DCIS

Testing the Ability of Pembrolizumab to Alter the Tumor Immune MicroEnvironment (TIME) of High Risk DCIS Scientific Title

Purpose
To study the effects (good and bad) of the immunotherapy pembroluzuimab on DCIS and the tissue surrounding DCIS.
Who is this for?
Women with high-risk DCIS planning to have surgery (mastectomy or lumpectomy).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI, at diagnosis and right before surgery</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by injection directly into the DCIS, 4 times, with 2 to 4 weeks between each injection</li> <li class="seamTextUnorderedListItem">Surgery (lumpectomy or mastectomy), 1 to 5 weeks after your last injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MRI, at diagnosis and right before surgery</li> <li class="seamTextUnorderedListItem">Tissue collection (biopsy of DCIS)</li> <li class="seamTextUnorderedListItem">Surgery (lumpectomy or mastectomy), within 4 months of diagnosis</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">checkpoint</span> inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">It is usually given by IV, but for this study it will be injected directly into the DCIS. </li> <li class="seamTextUnorderedListItem">Giving pembrolizumab (Keytruda®) before surgery allows researchers to study the effects it has on DCIS and the microenvironment (the tissue surrounding the DCIS).</li> <li class="seamTextUnorderedListItem">For this trial, high-risk DCIS means you meet at least 2 of the following: you are younger than 45, the DCIS is palpable (able to be felt by touch), larger than 5 cm, grade II-III, HER2 positive (HER2+), or hormone receptor negative (ER- and PR-).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02872025' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/symptoms/types/dcis/diagnosis' target='_blank'>Breastcancer.org: Diagnosis of DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforDuctalCarcinomaInSitu.html' target='_blank'>Susan G. Komen: Treatment for DCIS</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT02872025' target='_blank'>University of California San Francisco: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/researchers/laura-j-esserman' target='_blank'>BCRF: Laura J. Esserman (Study Researcher)</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=Cj0KCQjw6sHzBRCbARIsAF8FMpU1aXb3OCAoZH-Kz-lr_9qfn5S-yKDUnZ6zjvh8GAJBRQ5kuy7Ih0caAlUVE' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (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 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-) 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">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: 27 miles
Exelixis Clinical Site #21
Stanford,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03170960

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

A Phase 1b Dose-Escalation Study of Cabozantinib (XL184) Administered Alone or in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose
To assess the safety, best dose, and effects (good and bad) of cabozantinib (Cabometyx®) when it is used alone or with atezolizumab (Tecentriq®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has already 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">Atezolizumab (Tecentriq®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called an immune <span class="highlight">checkpoint</span> inhibitor. It is approved for use in combination with the chemotherapy drug Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is 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/NCT03170960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>Medlineplus: Cabozantinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.1026' target='_blank'>ASCOPubs.org: A phase II study of cabozantinib alone or in combination with trastuzumab in patients with breast cancer brain metastases</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: Atezolizumab Approved for Some Patients with TNBC</a> </li></ul>
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5

NEAREST SITE: 74 miles
University of California, Davis
Sacramento,CA

VISITS: At least 1 visit per month for 6 months

PHASE: I

NCT ID: NCT03970382

Personalized Immunotherapy With or Without Opdivo for HR+ Metastatic Breast Cancer

A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose
To determine the safety and the effects (good or bad) of an experimental T cell immunotherapy called neoTCR-P1 when it is given with or without nivolumab (Opdivo®).
Who is this for?
People with metastatic (stage IV) estrogen receptor-positive breast cancer that has been treated with at least one standard therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1, one time </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), once a month, for 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NeoTCR-P1 makes a patient's T cells target a neoepitope (neoE) that is found on their cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a <span class="highlight">checkpoint</span> inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been 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/NCT03970382' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/798453' target='_blank'>NCI Drug Dictionary: gene-edited autologous neoantigen-targeted NeoTCR-P1 T cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li></ul>
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6

NEAREST SITE: 86 miles
Pacific Cancer Care
Monterey,CA

VISITS: 3 visits per month, ongoing

PHASE: II

NCT ID: NCT03961698

IPI-549, Tecentriq® and Abraxane® for Advanced Triple-Negative Breast Cancer

A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination With Front-line Treatment Regimens in Patients With Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma Scientific Title

Purpose
To study the effects of IP-549 when it is used with atezolizumab (Tecentriq®) and paclitaxel (Abraxane®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-,PR-,HER2-) breast cancer that has not been treated with 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">IPI-549, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IP-549 is a type of experimental targeted therapy called a PI3K-gamma inhibitor. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called a PD-L1 <span class="highlight">checkpoint</span> inhibitor. It is approved to treat locally advanced or metastatic triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">Abraxane is a chemotherapy drug used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03961698' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.infi.com/home/our-development-program/ipi-549/' target='_blank'>Drug Company Information Page: IPI-549</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com/sclc.html?c=pdl-16d97f8fb9c&gclid=Cj0KCQiAtrnuBRDXARIsABiN-7Ap43URSS2rpiy3bh9KrbUqV-3pLCuvw7edYCY1v2MKoHoTdD369TUaArAsEALw_wcB&gclsrc=aw.ds' target='_blank'>Genentech Information Page: Tecentriq®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abraxane.com' target='_blank'>Drug Company Information Page: Abraxane®</a> </li></ul>
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7

NEAREST SITE: 339 miles
Novartis Investigative Site
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02890069

Immunotherapy Plus a Targeted Drug for Advanced Triple Negative Breast Cancer

Phase Ib, Open-label, Multi-center Study to Characterize the Safety, Tolerability and Pharmacodynamics (PD) of PDR001 in Combination With LCL161, Everolimus (RAD001) or Panobinostat (LBH589) Scientific Title

Purpose
To look at whether a new checkpoint inhibitor, a type of immunotherapy drug, is safe and effective when given along with a targeted drug.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. (ER-, PR, HER2-) Your cancer must have progressed on or not responded to available 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 be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PDR001 and LCL161</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PDR001 and everolimus (Afinitor®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PDR001 and Panobinostat (LBH589)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug used in this study is called PDR001. </li> <li class="seamTextUnorderedListItem">You will receive one of three targeted drugs: LCL161, everolimus (Afinitor®), or panobinostat (LBH589).</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02890069' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2016-01890' target='_blank'>Cancer.gov Trial Information</a> </li></ul>
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8

NEAREST SITE: 441 miles
UCSD Moores Cancer Center
San Diego,CA

VISITS: Weekly visits for 3 weeks

PHASE: I

NCT ID: NCT03841110

FT500 Alone or With Immunotherapy for Advanced HER2-positive Breast Cancer

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1) Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of giving FT500 alone or with immunotherapy.
Who is this for?
People with HER2-positive advanced (some stage III) or metastatic (stage IV) breast cancer. Your cancer must have progressed after being treated with nivolumab (Opdivo®), pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT500, by IV, weekly, for 3 weeks</li> <li class="seamTextUnorderedListItem">Cyclophosphamide and Fludarabine</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT500, by IV, weekly for 3 weeks</li> <li class="seamTextUnorderedListItem">Combined with an Immune <span class="highlight">Checkpoint</span> Inhibitor: Nivolumab (Opdivo®), Pembrolizumab (Keytruda®) or Atezolizumab (Tecentriq®) </li> <li class="seamTextUnorderedListItem">Cyclophosphamide and Fludarabine</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT500 is a natural killer (NK) cell immunotherapy. </li> <li class="seamTextUnorderedListItem">NK cells are specialized immune cells that can fight cancer cells. </li> <li class="seamTextUnorderedListItem">Cyclophosphamide and fludarabine are chemotherapy drugs used to deplete lymph cells.</li> <li class="seamTextUnorderedListItem">Opdivo, Tecentriq and Keytruda are each a type of immunotherapy drug called a PD-1 (programmed cell death-1) inhibitor. They are approved to treat certain other types of cancers, but their use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03841110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://health.ucsd.edu/news/releases/Pages/2019-04-01-UC-San-Diego-Health-Treats-Cancer-Patient-with-Stem-Cell-Derived-Natural-Killer-Cells.aspx' target='_blank'>UCSD Health: UC San Diego Health Treats 1st Cancer Patient with Stem-Cell Derived Natural Killer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.the-scientist.com/news-opinion/clinical-trial-underway-for-a-natural-killer-cell-therapy-65845' target='_blank'>The Scientist: Clinical Trial Underway for a Natural Killer Cell Therapy</a> </li></ul>
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9

NEAREST SITE: 602 miles
Novartis Investigative Site
Salt Lake City,UT

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT02947165

NIS793 with Spartalizumab (PDR001) in Patients With Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center Dose Escalation Study of NIS793 in Combination With PDR001 in Adult Patients With Advanced Malignancies Scientific Title

Purpose
To study the safety, effects (good and bad) and best dose of NIS793 when it is used alone or with an immunotherapy.
Who is this for?
People with locally advanced (stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other standard treatment options available.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIS793, by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab (PDR001), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">NIS793, by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIS793 is a targeted therapy that binds to the transforming growth factor-beta receptor. </li> <li class="seamTextUnorderedListItem">Spartalizumab is the investigational immunotherapy being used in this study. It is a type of immunotherapy called a PD-L1 <span class="highlight">checkpoint</span> inhibitor. </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/NCT02947165' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Dictionary: Spartalizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-tgf-beta-monoclonal-antibody-nis793' target='_blank'>NCI Dictionary: NIS793</a> </li></ul>
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10

NEAREST SITE: 941 miles
University of Colorado Aurora
Aurora,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03739931

mRNA-2752 & Durvalumab for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36γ, for Intratumoral Injection Alone and in Combination With Immune Checkpoint Blockade Scientific Title

Purpose
To study the safety, best dose and effects (good and bad) of mRNA-2752 when it is combined with durvalumab (Imfinzi®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has already been treated with adequate standard of care 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 the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"> mRNA-2752, by injection</li> <li class="seamTextUnorderedListItem">IMFINZI® (durvalumab), by IV</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">mRNA-2752 is injected directly into a tumor. It is designed to make a tumor more responsive to an immunotherapy drug. </li> <li class="seamTextUnorderedListItem">Imfinzi® is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It works by stimulating the body's immune system to go after cancer cells. It has been approved to treat certain types of cancers. 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/NCT03739931' 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_ph&uplace=durvalumab&outcome=dtc&cmpid=1' target='_blank'>AstraZeneca Drug Information Page: Imfinzi®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796816' target='_blank'>NCI Drug Dictionary: mRNA-2752</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/79/13_Supplement/CT210' target='_blank'>AACR Abstract: mRNA-2752</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.modernatx.com/pipeline/therapeutic-areas/immuno-oncology' target='_blank'>Drug Company Information Page: Intratumoral Immuno-Oncology Therapeutics</a> </li><li class='seamTextUnorderedListItem'><a href='https://stm.sciencemag.org/content/11/477/eaat9143.full?ijkey=nRihB/hFvaoUw&keytype=ref&siteid=scitransmed' target='_blank'>Journal Article: Durable anticancer immunity from intratumoral administration of IL-23, IL-36γ, and OX40L mRNAs</a> </li></ul>
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11

NEAREST SITE: 948 miles
Sarah Cannon Research Institute at HealthOne
Denver,CO

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04148937

The Targeted Therapy LY3475070 Alone or With Pembrolizumab in Advanced Breast Cancer

A Phase 1 Multicenter Global First in Human Study of the CD73 Inhibitor LY3475070 as Monotherapy or in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies Scientific Title

Purpose
To study the safety, anti-cancer activity, and effects (good and bad) of the experimental targeted therapy LY3475070 when it is given alone or with the immunotherapy pembrolizumab (Keytruda®).
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) breast cancer who have no other 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3475070, by mouth, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3475070, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3475070 is a type of investigational therapy called a CD73 inhibitor. </li> <li class="seamTextUnorderedListItem">CD73 is a protein that may be a new biomarker in triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a <span class="highlight">checkpoint</span> 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 other types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study also is 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/NCT04148937' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lillytrialguide.com/en-US/studies/advanced-cancer/jzma' target='_blank'>Eli Lilly & Company Trial Page</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=pembrolizumab&utm_kxconfid=sq7irm3mh&gclid=CjwKCAiA1L_xBRA2EiwAgcLKA1rjY2sDvGijJBKlq4pryVynCh4LO-tR1STTRbK7a6-qFcn3XQre2RoC' target='_blank'>Merck Oncology: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='http://tcr.amegroups.com/article/view/21463/html' target='_blank'>Journal Article: CD73, A New Biomarker in Triple-negative Breast Cancer</a> </li></ul>
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12

NEAREST SITE: 1387 miles
Stephenson Cancer Center
Oklahoma City,OK

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03775850

Immunotherapy EDP1503 With Pembrolizumab For Advanced Triple Negative Breast Cancer

A Phase I/II Open-label Study of EDP1503 Alone and in Combination With Pembrolizumab in Patients With Advanced Metastatic Colorectal Carcinoma, Triple-negative Breast Cancer, and Checkpoint Inhibitor Relapsed Tumors Scientific Title

Purpose
To assess the safety and the effects (good and bad) of the immunotherapy EDP1503 when it is given along with pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) and have no other approved treatment options available.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 alone, by mouth, twice daily for 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">followed by</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 alone, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">EDP1503 is an experimental immunotherapy that may work by changing the microenvironment that surrounds the cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is only approved to treat certain types of cancers. 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/NCT03775850' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795263' target='_blank'>NCI: Monoclonal microbial EDP1503</a> </li><li class='seamTextUnorderedListItem'><a href='https://globenewswire.com/news-release/2019/01/04/1680530/0/en/Evelo-Biosciences-Announces-Dosing-of-First-Patient-in-Phase-1-2-Clinical-Trial-of-EDP1503-in-Combination-with-KEYTRUDA-pembrolizumab-in-Multiple-Oncology-Indications.html' target='_blank'>Evelo Press Release: EDP1503</a> </li></ul>
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13

NEAREST SITE: 1481 miles
The START Center for Cancer Care
San Antonio,TX

VISITS: 1 visit every 2 or 3 weeks, ongoing

PHASE: I

NCT ID: NCT02791334

Immunotherapy LY3300054 Alone and in Combination in Advanced Breast Cancer

A Phase 1a/1b Study of a Novel Anti-PD-L1 Checkpoint Antibody (LY3300054) Administered Alone or in Combination With Other Agents in Advanced Refractory Solid Tumors (Phase 1a/1b Anti-PD-L1 Combinations in Tumors-PACT) Scientific Title

Purpose
To test the safety and effects (good and bad) of LY3300054 when it is used alone or in combination with a targeted therapy or an immunotherapy.
Who is this for?
People with locally advanced (stage III) or metastatic (stage IV) breast cancer that is hormone receptor positive and HER2-negative or tests positive for high microsatellite instability (MSI-H). You must also have had at least 1 but no more than 3 chemotherapy regimens in the metastatic setting.    Full eligibility criteria
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  • <p class="seamTextPara"> For phase 1a, participants will be assigned to one of the following groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 by IV, every 2 or 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 by IV, every 2 or 3 weeks</li> <li class="seamTextUnorderedListItem">Ramucirumab by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Abemaciclib by mouth, twice daily</li> </ul> <p class="seamTextPara"> For the expansion cohort (phase 1b), participants will be assigned to one of the following groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 by IV, every 2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Abemaciclib by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 and LY3321367 by IV, every 2 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3300054 is a type of immunotherapy called a <span class="highlight">checkpoint</span> inhibitor. </li> <li class="seamTextUnorderedListItem">There are three other drugs being used in this study:</li> <li class="seamTextUnorderedListItem">LY3321367 is also an investigational <span class="highlight">checkpoint</span> inhibitor. </li> <li class="seamTextUnorderedListItem">Ramucirumab (Cyramza) is a targeted therapy that blocks VEGFR-2, which keeps tumors from forming new blood vessels. It is approved to treat certain types of solid tumors, but not breast cancer. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio) is a CDK 4/6 inhibitor approved to treat HR positive and HER2-negative metastatic breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02791334' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-tim3-monoclonal-antibody-ly3321367' target='_blank'>NCI Dictionary: LY3321367</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ramucirumab' target='_blank'>NCI Dictionary: Ramucirumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/abemaciclib' target='_blank'>NCI Dictionary: Abemaciclib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41523-018-0097-z?WT.ec_id=NPJBCANCER-201901&sap-outbound-id=A193F1E30B35A538FDD272FA9FA7EB16EE544364' target='_blank'>Nature: MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer</a> </li></ul>
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14

NEAREST SITE: 1481 miles
NEXT Oncology /ID# 208930
San Antonio,TX

VISITS: 1 visit every month, ongoing

PHASE: I

NCT ID: NCT03821935

ABBV-151 and ABBV-181 for Advanced Triple Negative Breast Cancer

A Phase 1 First-in Human, Multi-Center, Open Label Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics and RP2D of ABBV-151 as a Single Agent and in Combination With ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose
To investigate the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181.
Who is this for?
Men and women with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has been treated with at least one systemic therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of the 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">ABBV-181, by IV, once a month, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. </li> <li class="seamTextUnorderedListItem">ABBV-181 is an experimental PD-1 inhibitor. This type of immunotherapy, called a <span class="highlight">checkpoint</span> inhibitor, gets the immune system to see and go after cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03821935' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-151.html' target='_blank'>Drug company information page: ABBV-151</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/abbv-181/' target='_blank'>Immuno-oncology news: ABBV-181</a> </li></ul>
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15

NEAREST SITE: 1509 miles
University of Texas Southwestern Medical Center
Dallas,TX

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT03789110

Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2 Negative Breast Cancer

NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer (NIMBUS) Scientific Title

Purpose
To test the safety and effects (good and bad) of using two immunotherapy drugs in combination to treat metastatic breast cancer.
Who is this for?
People with HER2 negative metastatic (stage IV) breast cancer that is hypermutated (found to have at least 10 mutations per megabase) on a 300 gene panel test such as Foundation One, Oncopanel, or IMPACT.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®), by IV, every 6 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a <span class="highlight">checkpoint</span> inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">Ipilimumab (Yervoy®) gets the immune system to go after cancer cells by blocking a protein called CTLA-4. </li> <li class="seamTextUnorderedListItem">Yervoy and Opdivo are used in combination to treat patients with melanoma and certain other cancers. </li> <li class="seamTextUnorderedListItem">Their 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/NCT03789110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com/' target='_blank'>Bristol‑Myers Squibb Information Page: Opdivo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.yervoy.com/' target='_blank'>Bristol‑Myers Squibb Information Page: Yervoy</a> </li></ul>
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16

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

VISITS: 1 visit every 2 weeks, and 5 to 10 days of radiation therapy

PHASE: I

NCT ID: NCT03524170

Immunotherapy and Radiation Therapy for Metastatic ER+, HER2-Breast Cancer

RACHEL1: A Phase I Radiation and CHEckpoint bLockade Trial in Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer Scientific Title

Purpose
To determine the best dose, safety and effects (good and bad) of M7824 combined with radiation therapy.
Who is this for?
People with estrogen receptor positive and HER2 negative metastatic (stage IV) breast cancer. You must have at least two sites of metastatic disease by imaging.    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">M7824, by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, 5-10 days</li> <li class="seamTextUnorderedListItem">Biopsy after 2 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">M7824 (MSB0011359C) is a protein with two components: PD-L1 antibody and TGF-β receptor. </li> <li class="seamTextUnorderedListItem">M7824 is currently being used for research purposes only.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03524170' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://stm.sciencemag.org/content/10/424/eaan5488' target='_blank'>Science Translational Medicine: M7824</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/oncolog/radiation-may-enhance-immunotherapy-for-solid-tumors.h10-1591413.html' target='_blank'>MD Anderson Cancer Center: Radiation May Enhance Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5976948/' target='_blank'>Journal Article: Evolution of Radiation Therapy in MBC</a> </li></ul>
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17

NEAREST SITE: 1643 miles
Novartis Investigative Site
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03549000

NZV930, PDR001 and NIR178 Immunotherapies in Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center, Study of NZV930 as a Single Agent and in Combination With PDR001 and/or NIR178 in Patients With Advanced Malignancies. Scientific Title

Purpose
To compare the safety and effects (good and bad) of NZV930 alone or in combination with PDR001 and/or NIR178.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV </li> <li class="seamTextUnorderedListItem">PDR001, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV</li> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV</li> <li class="seamTextUnorderedListItem">PDR001, by IV</li> <li class="seamTextUnorderedListItem">NIR178, by mouth</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">2 biopsies (a new tumor biopsy at screening and during treatment)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930 is an investigational targeted therapy that blocks the CD73 protein. Blocking this protein allows T cells and other immune cells to attack the tumor. </li> <li class="seamTextUnorderedListItem">PDR001 is an investigational immunotherapy. It is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">NIR178 is an investigational immunotherapy. It is an immune <span class="highlight">checkpoint</span> inhibitor that gets the immune system to attack cancer cells by blocking the adenosine A2A receptor (A2AR).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03549000' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.surfaceoncology.com/our-science/srf373-nzv930-cd73-antibody/' target='_blank'>Sponsor site: AZV930</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793151' target='_blank'>NCI Drug Dictionary: NIR178</a> </li></ul>
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18

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 Keytruda in Metastatic Triple Negative 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 pembrolizumab (Keytruda®).
Who is this for?
People with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) 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">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 <span class="highlight">checkpoint</span> 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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19

NEAREST SITE: 1857 miles
University of Chicago
Chicago,IL

VISITS: Visits every 3 weeks, for 6 months

PHASE: II

NCT ID: NCT03487666

Opdivo plus Xeloda After Surgery for Triple Negative Breast Cancer

OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy Scientific Title

Purpose
To compare the effects (good and bad) of using two drugs alone or together after surgery.
Who is this for?
People with triple negative (ER-, PR-, and HER2-), DCIS, LCIS, or early stage (stage I, stage II or stage III) breast cancer that was treated with chemotherapy before surgery.    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">Nivolumab (Opdivo®), by IV, every 3 weeks, for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks, for 6 months</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, for 6 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs being used in this study are nivolumab (Opdivo®) and capecitabine (Xeloda®).</li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy drug called a PD-1 inhibitor. It is approved to treat certain types of metastatic melanoma and non-small cell lung cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Xeloda is a chemotherapy drug 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/NCT03487666' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li></ul>
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20

NEAREST SITE: 1959 miles
Novartis Investigative Site
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03742349

Four Immunotherapy Combinations in Advanced Triple Negative Breast Cancer

A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Immunotherapy Combinations in Adult Patients With Triple-negative Breast Cancer Scientific Title

Purpose
To study the safety, best dose and effects (good and bad) of spartalizumab and LAG525 when they are used in combination with NIR178, capmatinib, MCS110, or canakinumab.
Who is this for?
Men and women with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) who have not received more than two prior lines of chemotherapy, including neoadjuvant or adjuvant chemotherapy; and have had a taxane-based chemotherapy as neoadjuvant or metastatic treatment.    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">Spartalizumab (PDR001), by IV</li> <li class="seamTextUnorderedListItem">LAG525, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">with 1 of the following 4 drugs: </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> <li class="seamTextUnorderedListItem">Capmatinib (INC280), by mouth</li> <li class="seamTextUnorderedListItem">MCS110 (INC280), by IV</li> <li class="seamTextUnorderedListItem">Canakinumab (ACZ885), by injection</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab is an investigational PD-1 immune <span class="highlight">checkpoint</span> inhibitor. </li> <li class="seamTextUnorderedListItem">LAG525 is an investigational immune <span class="highlight">checkpoint</span> inhibitor that targets LAG-3. </li> <li class="seamTextUnorderedListItem">NIR178 is an investigational immunotherapy. </li> <li class="seamTextUnorderedListItem">Capmatinib is a targeted therapy that blocks c-Met, which plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">MCS110 is an investigational immunotherapy that targets M-CSF. </li> <li class="seamTextUnorderedListItem">Canakinumab is an investigational monoclonal antibody that targets human interleukin-1 beta (IL-1b), which plays a role in inflammation.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742349' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: Spartalizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-lag-3-monoclonal-antibody-lag525' target='_blank'>NCI Drug Dictionary: LAG525</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/capmatinib' target='_blank'>NCI Drug Dictionary: Capmatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-m-csf-monoclonal-antibody-mcs110' target='_blank'>NCI Drug Dictionary: MCS110</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795723' target='_blank'>NCI Drug Dictionary: Canakinumab</a> </li></ul>
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21

NEAREST SITE: 1959 miles
Novartis Investigative Site
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03891953

Immunotherapy DKY709 Alone or With PDR001 in Advanced Triple Negative Breast Cancer

A Phase I/Ib, Open-label, Multi-center, Study of DKY709 as a Single Agent and in Combination With PDR001 in Patients With Advanced Solid Tumors Scientific Title

Purpose
To compare the safety and effects (good and bad) of DKY709 alone and in combination with PDR001.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not been treated with a PD-1 or PD-L1 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 assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709</li> <li class="seamTextUnorderedListItem">PDR001 (Spartalizumab)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709 is an investigational immunotherapy. </li> <li class="seamTextUnorderedListItem">PDR001 (spartalizumab) is an investigational immunotherapy that targets PD-1 .</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03891953' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: Spartalizumab</a> </li></ul>
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22

NEAREST SITE: 1959 miles
Tennessee Oncology, PLLC
Nashville,TN

VISITS: 1 visit a week, ongoing

PHASE: I-II

NCT ID: NCT04180371

BT5528 Alone or With Nivolumab in Advanced Triple Negative Breast Cancer That Tests EphA2+

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT5528 in Patients With Advanced Malignancies Associated With EphA2 Expression Scientific Title

Purpose
To study the safety, effects (good and bad), and best dose of an experimental therapy called BT5528 when it is given alone or with nivolumab (Opdivo®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-), have already tried other cancer treatments, have no other standard treatment options, and have a tumor that tests positive for a protein called EphA2.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> This trial is being conducted in two parts. You will participate in 1 of 2 parts depending on when you enroll: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Part 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once every 4 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT5528 targets a protein called EphA2 that helps cancer cells grow. </li> <li class="seamTextUnorderedListItem">EphA2 is found on some triple negative breast tumors. </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a <span class="highlight">checkpoint</span> inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It 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/NCT04180371' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Information Page: BT5528</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/onc2017170' target='_blank'>Journal Article: Targeting EphA2 In Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.opdivo.com/about-opdivo/how-opdivo-works-monotherapy' target='_blank'>Bristol-Meyers Squibb Information Page: Opdivo</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/publications/cure/2019/immunotherapy-2019/breast-cancer-gets-a-boost-from-immunotherapy' target='_blank'>Cure Today: Breast Cancer Gets a Boost From Immunotherapy</a> </li></ul>
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23

NEAREST SITE: 2371 miles
University of Virginia
Charlottesville,VA

VISITS: Visits weekly or every 2 weeks for 6 months

PHASE: II

NCT ID: NCT02957968

Keytruda & Decitabine Followed by Chemo Before Surgery for Locally Advanced HER2- Disease

T-Cell Immune Checkpoint Inhibition Plus Hypomethylation for Locally Advanced HER2-Negative Breast Cancer - A Phase 2 Neoadjuvant Window Trial of Pembrolizumab and Decitabine Followed by Standard Neoadjuvant Chemotherapy Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of using immunotherapy before standard neoadjuvant chemotherapy.
Who is this for?
People with stage III HER2 negative breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups and receive the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Triple Negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Decitabine and pembrolizumab (Keytruda®), schedule determined by the physician</li> <li class="seamTextUnorderedListItem">followed by AC (Adriamycin®/Cytoxan®), by IV, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">followed by paclitaxel and carboplatin, by IV, weekly, for 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2-negative, ER/PR-positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Decitabine and pembrolizumab (Keytruda®), schedule determined by the physician</li> <li class="seamTextUnorderedListItem">followed by AC (Adriamycin®/Cytoxan®), by IV, once every 2 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">followed by paclitaxel, by IV, weekly, for 3 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Giving chemotherapy before surgery (called neoadjuvant treatment) can shrink the tumor. It also allows researchers to study the effect the treatment has on the cancer cells. </li> <li class="seamTextUnorderedListItem">The immunotherapy (treatment that uses your body's own immune system to help fight cancer) used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of metastatic lung cancer. </li> <li class="seamTextUnorderedListItem">It will be given along with the chemotherapy drug decitabine (Dacogen®), which is used to treat a certain type of blood cancer. </li> <li class="seamTextUnorderedListItem">The standard chemotherapy drugs used in this study are doxorubicin (Adriamycin®), cyclophosphamide (Cytoxan®)®known as AC®and paclitaxel (Taxol). </li> <li class="seamTextUnorderedListItem">If your tumor is triple negative, you will also receive carboplatin (Paraplatin).</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02957968' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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24

NEAREST SITE: 2376 miles
University of Virginia
Charlottesville,VA

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

PHASE: I

NCT ID: NCT03237572

Focused Ultrasound and Pembrolizumab in Advanced Breast Cancer

Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer Scientific Title

Purpose
To evaluate the safety and effects (good and bad) of using high-intensity focused ultrasound (HIFU) along with Keytruda to treat metastatic breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer. You must have already been treated with a CDK4/6 inhibitor in combination with an anti-estrogen therapy.    Full eligibility criteria
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  • 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">High intensity focused ultrasound (HIFU), once, prior to starting treatment with Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 9 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">High intensity focused ultrasound (HIFU), once, after first dose of Pembrolizumab (Keytruda®)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 9 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HIFU is a treatment that works to kill cancer cells with high frequency sound waves. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to fight cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03237572' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/other/high-intensity-focused-ultrasound-hifu' target='_blank'>CancerResearchUK: High-Intensity Focused Ultrasound</a> </li></ul>
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25

NEAREST SITE: 2395 miles
H. Lee Moffitt Cancer Center and Research Institute
Tampa,FL

VISITS: 1 visit every 4 weeks, ongoing

PHASE: I

NCT ID: NCT03807765

Stereotactic Radiation and Nivolumab for Metastatic Breast Cancer with Brain Metastases

Phase Ib Study of Stereotactic Radiation and Nivolumab in the Management of Metastatic Breast Cancer Brain Metastases Scientific Title

Purpose
To study the safety and effects of using stereotactic radiosurgery to treat brain metastases in patients who have received nivolumab (Opdivo®).
Who is this for?
People with metastatic (stage IV) breast cancer with brain metastases not previously treated with whole brain radiation.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 4 weeks</li> <li class="seamTextUnorderedListItem">Stereotactic Radiosurgery (SRS), once, during the week after the first dose of Nivolumab</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery is a type of very targeted radiation therapy. </li> <li class="seamTextUnorderedListItem">Opdivo is a <span class="highlight">checkpoint</span> inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03807765' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.radiologyinfo.org/en/info.cfm?pg=stereotactic' target='_blank'>RadiologyInfo.org: Stereotactic Radiosurgery (SRS)</a> </li></ul>
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