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Profile: ER-/PR-/HER2- • Disease in: Bone and Liver

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Brain: Leptomeningeal Mets required

BRCA1/2 (inherited)

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Targeted Therapy: CDK Inhibitors

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No travel requiredTrials coming soon to MTSAdditional metastatic cancer trials

1

NEAREST SITE: 0 miles
Robert H. Lurie Comprehensive Cancer Center | Northwestern University
Chicago, IL

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03544723

Gene Therapy Ad-p53 In Combination With Immunotherapy for Advanced Breast Cancer

A Phase 2, Multi-Center, Open Label Study to Evaluate Efficacy and Safety of Adenoviral p53 (Ad-p53) in Combination With Immune Checkpoint Inhibitor Therapy in Patients With Progression or Recurrence of Head and Neck Squamous Cell Carcinoma (HNSCC) Scientific Title

Purpose
To study the safety and anti-cancer activity of giving the gene therapy Ad-p53 in combination with a PD-1 or PD-L1 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ad-p53, by injection, directly into your tumor</li> <li class="seamTextUnorderedListItem">Doctor's choice of PD-1 inhibitor or PD-L1 inhibitor, 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">Ad-p53 is a type of gene therapy.</li> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts genetic material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy called a checkpoint inhibitor. They get the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">PD-L1 inhibitors are also checkpoint inhibitors. They stimulate your immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death-ligand 1).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced and metastatic cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03544723' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ad5cmv-p53-gene' target='_blank'>NCI Drug Dictionary: Ad-p53</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/cancer-talk/First-Immunotherapy-Approved-for-Breast-Cancer.aspx' target='_blank'>Cancer Today: First Immunotherapy Approved for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/PD-1_and_PD-L1_inhibitors' target='_blank'>Wikipedia: PD-1 and PD-L1 inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gene-therapy' target='_blank'>NCI Dictionary of Cancer Terms: Gene Therapy</a> </li></ul>
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2

NEAREST SITE: 0 miles
Los Angeles Hematology Oncology Medical
Los Angeles, CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04596150

CX-2009 Alone or with the Experimental PD-L1 Inhibitor CX-072 for Advanced HER2 Negative Breast Cancer

A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of CX-2009 in Advanced HR-Positive/HER2-Negative Breast Cancer and of CX-2009 as Monotherapy and in Combination With CX-072 in Advanced Triple-Negative Breast Cancer Scientific Title

Purpose
To study the safety and anti-cancer activity of giving CX-2009 alone and in combination with CX-072.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer or triple negative (ER-, PR-, HER2-) breast cancer that tests positive for high CD166 expression or is PD-L1 positive.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 3 groups and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Hormone positive, HER2 negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-2009, by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Triple negative, CD166 expression</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-2009, by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Triple negative, PD-L1 positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-2009, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">CX-072, by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-2009 is an experimental therapy that targets the protein CD166 on cancer cells to deliver the anti-cancer drug DM4.</li> <li class="seamTextUnorderedListItem">CX-072 is a type of an experimental immunotherapy called a PD-L1 inhibitor. </li> <li class="seamTextUnorderedListItem">Targets or mutations: CD166, PD-L1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04596150' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cytomx.com/pipeline/' target='_blank'>CytomX Therapeutics Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.526' target='_blank'>Journal Abstract: CX-2009, a CD166-Directed Probody Drug Conjugate</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/cx-072/' target='_blank'>Immunotherapy-Oncology News: CX-072</a> </li></ul>
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3

NEAREST SITE: 0 miles
Texas Oncology - Austin Central
Austin, TX

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT05001347

Uliledlimab With Atezolizumab for Advanced Triple-Negative, PD-L1 Positive Breast Cancer

A Phase 2 Clinical Study of TJ004309 in Combination With Atezolizumab (TECENTRIQ®) in Patients With Advanced or Metastatic Ovarian Cancers and Selected Advanced Solid Tumors Scientific Title

Purpose
To study the effects (good and bad) and anti-cancer activity of uliledlimab (TJ004309), an experimental immunotherapy called a CD73 inhibitor, in combination with atezolizumab (Tecentriq®) immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 positive breast cancer who have received 2-5 lines of therapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Uliledlimab (TJ004309), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Uliledlimab (TJ004309) is an experimental immunotherapy called a CD73 inhibitor. Blocking CD73 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor or a checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</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/NCT05001347' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.traconpharma.com/tj004309/' target='_blank'>Tracon Pharma Drug Information Page: Uliledlimab (TJ004309)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com/' target='_blank'>Genentech Drug Information Page: Atezolizumab (Tecentriq®)</a> </li></ul>
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4

NEAREST SITE: 0 miles
University of Colorado Hospital
Aurora, CO

VISITS: 3 visits every month following radiation therapy

PHASE: II

NCT ID: NCT05233696

Radiation with Chemotherapy and Immunotherapy for Advanced PD-L1 Positive, Triple Negative Breast Cancer

Phase II Study of Radiotherapy in Combination With Chemotherapy and Immunotherapy in Patients With PD-L1-Positive Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose
To study the effects (good and bad) and anti-cancer activity of radiation therapy in combination with nab-paclitaxel (Abraxane®) or paclitaxel (Taxol®) chemotherapy and pembrolizumab (Keytruda®) immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) PD-L1 positive (PD-L1+), triple-negative (ER-, PR-, HER2-) breast cancer that have received two or more chemotherapies.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy</li> </ul> <p class="seamTextPara"> followed by </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) or paclitaxel (Taxol®), by IV, weekly, 2 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 2 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) and paclitaxel (Taxol®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and 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/NCT05233696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation-therapy' target='_blank'>Breastcancer.org: Radiation Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>
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5

NEAREST SITE: 0 miles
University of Alabama at Birmingham
Birmingham, AL

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT04690855

PARP Inhibitor, Radiation Therapy, and Immunotherapy for Metastatic TNBC that is PD-L1+

A Multi-institutional Phase II Study to Evaluate Efficacy and Safety of TAlazoparib, Radiotherapy and Atezolizumab in gBRCA 1/2 Negative Patients With PD-L1+ Metastatic Triple Negative Breast Cancer (TARA) Scientific Title

Purpose
To study the anti-cancer activity, safety, and side effects of giving a PARP inhibitor, followed by high dose radiation to metastatic tumors and ongoing immunotherapy.
Who is this for?
People with metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer. Your tumor must test PD-L1 positive, and you must not have an inherited BRCA1/2 mutation. Additionally, you must not have received more than two lines of chemotherapy for metastatic disease or any PARP inhibitors.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, for 1 month</li> <li class="seamTextUnorderedListItem">followed by high-dose radiation therapy, every other day, 3 times</li> <li class="seamTextUnorderedListItem">followed by atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA in tumor cells. </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04690855' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/does-immunotherapy-treat-breast-cancer.h00-159385101.html' target='_blank'>MD Anderson Cancer Center: Does Immunotherapy Treat Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/talazoparib.aspx' target='_blank'>Chemocare: Talazoparib (Talzenna®)</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 Approved for Some Patients with Triple-Negative Breast Cancer</a> </li></ul>
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6

NEAREST SITE: 0 miles
Texas Oncology- Austin Central
Austin, TX

VISITS: Every week (2 weeks on, 1 week off), ongoing

PHASE: III

NCT ID: NCT04799249

Chemotherapy and an Investigational CDK 4/6 Inhibitor for Advanced Triple Negative Breast Cancer

A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2) Scientific Title

Purpose
To study and compare the safety, side effects, and anti-cancer activity of giving two chemotherapies with the investigational CDK 4/6 inhibitor trilaciclib (Cosela) to chemotherapy alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple-negative breast cancer. You must have never received treatment for advanced disease and have never received an anti-PD-L1/PD-1 inhibitor. Or, your cancer must test positive for PD-L1, and your most recently received therapy must have been an anti-PD-L1/PD-1 inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Trilaciclib and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Placebo and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, every week (2 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela) is a type of targeted therapy called a CDK 4/6 inhibitor. Trilaciclib is approved for use in people with other types of cancer, but its use for breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and paraplatin are the chemotherapies used in this trial. They are routinely used to treat advanced and 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/NCT04799249' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.g1therapeutics.com/pipeline/trilaciclib/' target='_blank'>G1 Therapeutics Drug Information Page: Trilaciclib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/gemcitabine.aspx' target='_blank'>Chemocare: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/carboplatin' target='_blank'>Cancer Research UK: Carboplatin (Paraplatin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>
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7

NEAREST SITE: 0 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

VISITS: One or two hospital stays are required, then 1 visit every 3 week, ongoing

PHASE: I-II

NCT ID: NCT04639245

T-Cell Immunotherapy and a PD-L1 Inhibitor for Metastatic Triple Negative Breast Cancer that is MAGE-A1 Positive

ATTAMAGE-A1.: Phase I/II Study of Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity MAGE-A1-Specific T-Cell Receptor (TCR) Combined With Atezolizumab in Patients With Metastatic MAGE-A1 Expressing Cancer Scientific Title

Purpose
To study the safety, side effects, and anti-cancer activity of giving the experimental T-cell immunotherapy FH-MagIC TCR-T with or without the PD-L1 inhibitor atezolizumab (Tecentriq®).
Who is this for?
People with metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer whose tumors express MAGE-A1. You must have already received at least one chemotherapy for metastatic disease and a PD-1 inhibitor for any stage of breast cancer.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, 3 times over 1 week</li> <li class="seamTextUnorderedListItem">followed by FH-MagIC TCR-T (T-Cell immunotherapy), by IV, one or two times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®), by IV, 3 times over 1 week</li> <li class="seamTextUnorderedListItem">followed by FH-MagIC TCR-T (T-Cell immunotherapy), by IV, one or two times</li> <li class="seamTextUnorderedListItem">followed by atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact the research site for the treatment schedule. A hospital stay will be required.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your tumor will be tested and must test positive for MAGE-A1 expression to enroll in this trial. </li> <li class="seamTextUnorderedListItem">FH-MagIC TCR-T is a type of T-cell immunotherapy. </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of metastatic cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: MAGE-A1</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04639245' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/atezolizumab.aspx' target='_blank'>Chemocare: Atezolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>NCI Cancer Treatment: T-Cell Transfer Therapy</a> </li></ul>
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8

NEAREST SITE: 0 miles
Kymab investigational site 1103
Nashville, TN

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03829501

KY1044 and Immunotherapy Atezolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of KY1044 as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of using immunotherapy KY1044 alone or with the PD-1 inhibitor Tecentriq® (atezolizumab).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-,PR-,HER2-) breast cancer that has not responded to other treatment options.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Monotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Combination Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), 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">KY1044 stimulates immune cells to go after and kill cancer cells. </li> <li class="seamTextUnorderedListItem">It also kills the T regulatory cells that keep immune cells from killing the cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq® (atezolizumab) is a type of immunotherapy called a PD-L1 (programmed cell death-ligand 1) inhibitor. </li> <li class="seamTextUnorderedListItem">It is approved to treat advanced triple negative breast cancer, as well as certain types of bladder and lung cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03829501' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.kymab.com/news-and-events/news/2017/nov/8/ky1044-anti-icos-antibody-sitc/' target='_blank'>Drug Sponsor Site: KY1044</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/american-society-of-clinical-oncology-asco/asco-2018/first-in-class-icos-agonist-alone-or-in-combination-may-be-effective-for-advanced-cancer/' target='_blank'>StatNews: Tecentriq approval for breast cancer</a> </li></ul>
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9

NEAREST SITE: 0 miles
Henry Ford Health System ( Site 0002)
Detroit, MI

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03918278

MK-0482, Pembrolizumab, and Paclitaxel for Advanced Triple Negative Breast Cancer that Tests Positive for PD-L1

A Phase 1b, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0482 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors. Scientific Title

Purpose
To study the safety, side effects, and anti-cancer activity of giving the experimental therapy MK-0482 in combination with immunotherapy and chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR, HER2-) breast cancer that tests positive for PD-L1. You must not have already received treatment for metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-0482, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-0482 is an experimental therapy. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved for use in many cancers, including in people with advanced triple-negative breast cancer in combination with chemotherapy, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely 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/NCT03918278' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.msdonctriallink.com/MK-0482/' target='_blank'>Merck: MSD Oncology Pipeline</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-locally-recurrent-unresectable-or-metastatic-triple' target='_blank'>US Food and Drug Administration: FDA Grants Accelerated Approval to Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-019-1210-4' target='_blank'>Journal Article: Current Treatment Landscape for Patients with Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer</a> </li></ul>
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10

NEAREST SITE: 0 miles
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, CA

VISITS: Number of visits varies, ongoing

PHASE: II

NCT ID: NCT03606967

Chemotherapy & Immunotherapy With or Without A Personalized Vaccine for Metastatic Triple Negative Breast Cancer That Is PD-L1 Negative

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + MEDI4736 (Durvalumab) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose
To study the safety and anti-cancer activity of giving chemotherapy, the immunotherapy tremelimumab, and the PD-L1 inhibitor Durvalumab (Imfinzi®) together with or without a personalized synthetic long peptide (SLP) vaccine and Hiltonol® (poly-ICLC) .
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that is PD-L1 negative and who have not yet received any 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: Vaccine</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Personalized SLP Vaccine and Hiltonol® (poly-ICLC), 7 times over 2.5 months</li> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, every week (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: No Vaccine</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and carboplatin (Paraplatin®), by IV, every week (2 weeks on, 1 week off), for 4.5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tremelimumab, by IV, once a month, for 4 months</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, once a month, 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">The type of vaccine used in this trial is called a personalized synthetic long peptide (SLP) vaccine. It may help your immune system see and fight cancer cells. </li> <li class="seamTextUnorderedListItem">Hiltonol® (poly-ICLC) is an immune cell activating factor.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) is a chemotherapy routinely used to treat advanced and metastatic triple negative breast cancer.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Tremelimumab is a type of immunotherapy called a CTLA-4 inhibitor.</li> <li class="seamTextUnorderedListItem">Durvalumab (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, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat 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/NCT03606967' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search/Personalized%20Synthetic%20Long%20Pe/?searchMode=Begins' target='_blank'>NCI Drug Dictionary: Personalized Synthetic Long Peptide Breast Cancer Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncovir.com' target='_blank'>Oncovir Drug Information Page: Hiltonol® (poly-ICLC)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Tremelimumab' target='_blank'>Wikipedia: Tremelimumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/durvalumab' target='_blank'>NCI Drug Dictionary: Durvalumab (Imfinzi®)</a> </li></ul>
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11

NEAREST SITE: 0 miles
Dana Farber Cancer Institute
Boston, MA

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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  • <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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12

NEAREST SITE: 0 miles
Sanford Cancer Center-Gynecologic Oncology ( Site 1015)
Sioux Falls, SD

VISITS: 1-5 visits per month

PHASE: II

NCT ID: NCT05007106

Pembrolizumab/Vibostolimab for Advanced Triple Negative Breast Cancer That is PD-L1 Positive

A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (KEYVIBE-005) Scientific Title

Purpose
To study the effects and anti-cancer activity of MK-7684A, an experimental combination immunotherapy containing pembrolizumab and vibostolimab, alone and in combination with chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-), PD-L1 positive breast cancer who have not received treatment with pembrolizumab (Keytruda®) or atezolizumab (Tecentriq®).    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">5-fluorouracil (Fluracil®), by IV, for 5 consecutive days every 3 weeks</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab/vibostolimab (MK-7684A), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on, 1 week off</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-7684A is an experimental combination immunotherapy containing pembrolizumab and vibostolimab.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Vibostolimab is an experimental type of immunotherapy called a TIGIT inhibitor. Blocking TIGIT may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">5-fluorouracil (Fluracil®), cisplatin (Platinol®), and paclitaxel (Taxol®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05007106' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/vibostolimab-pembrolizumab-mk-7684a?redirect=true' target='_blank'>National Cancer Institute: MK-7684A</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.annalsofoncology.org/article/S0923-7534(21)04776-1/fulltext' target='_blank'>Journal Article: Vibostolimab as Monotherapy or With Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/' target='_blank'>Merck Drug Information Page: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li></ul>
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13

NEAREST SITE: 0 miles
Moffit Cancer Center
Tampa, FL

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT04332653

Immunotherapies Hyleukin-7 and Pembrolizumab for Advanced Triple Negative Breast Cancer

An Open-label Phase 1b/2a Study of NT-I7 (Hyleukin-7) in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Advanced Solid Tumors Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of combining the experimental immunotherapy Hyleukin-7 with the PD-1 checkpoint inhibitor pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose disease progressed after receiving a PD-1/PD-L1 inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Hyleukin-7 (NT-17), by injection, every 6 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Hyleukin-7 (NT-17) is an experimental immunotherapy. This means it is only available in clinical trials. </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">This trial is also 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/NCT04332653' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='http://neoimmunetech.com/technology/page01.html' target='_blank'>NeoImmuneTech Drug Information Page: Hyleukin-7 (NT-17)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793669' target='_blank'>NCI Drug Dictionary: Efineptakin Alfa (Hyleukin-7)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor+PEMBROLIZUMAB+ONLY_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Generic+Keyword_General&kw=pembrolizumab&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwmMX4BRAAEiwA-zM4Jt_FsXjBbCDQmDpAauIhhxyGABNsAMua9ha' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li></ul>
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14

NEAREST SITE: 0 miles
University of Chicago Medical Center
Chicago, IL

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 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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15

NEAREST SITE: 0 miles
Hackensack University Medical Center
Hackensack, NJ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05069935

FT538 NK Cell Therapy for Advanced Triple Negative or HER2+ Breast Cancer

A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors Scientific Title

Purpose
To study the safety and best dose of FT538, an experimental type of immunotherapy called NK cell therapy, with immunotherapy or targeted therapy and chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), HER2 low (IHC 2+), or HER2 positive (HER2+) breast cancer that has progressed after standard treatment. If your cancer is HER2+, you must have received at least 2 lines of therapy.    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 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: FT538 NK cell therapy plus immunotherapy and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT538 NK cell therapy</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: FT538 NK cell therapy plus targeted therapy and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT538 NK cell therapy</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV or pembrolizumab (Keytruda®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: FT538 NK cell therapy plus HER2-targeted therapy and chemotherapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT538 NK cell therapy</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require 1 biopsy</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT538 NK cell therapy is an experimental type of immunotherapy called natural killer (NK) cell therapy.</li> <li class="seamTextUnorderedListItem">NK cells are specialized immune cells that can fight cancer cells.</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), nivolumab (Opdivo®), and pembrolizumab (Keytruda®) are types of immunotherapy called immune checkpoint inhibitors and PD-1/PD-L1 inhibitors.</li> <li class="seamTextUnorderedListItem">Blocking PD-1/PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of HER2 targeted therapy.</li> <li class="seamTextUnorderedListItem">Before you receive FT538 NK cell therapy, you will be given the chemotherapy drugs cyclophosphamide (Cytoxan®) and fludarabine (Fludara®). These drugs are given to prepare your immune system to receive the immunotherapy.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 positive is defined as IHC 2+ or 3+.</li> <li class="seamTextUnorderedListItem">This trial is also 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/NCT05069935' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://fatetherapeutics.com/pipeline/immuno-oncology-candidates/ft538/' target='_blank'>Fate Therapeutics Drug Information Page: FT538</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/car-nk-therapy-offers-new-treatment-option-for-blood-cancers.h00-159379578.html' target='_blank'>MD Anderson Cancer Center: NK Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-adoptive-cell-therapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>
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16

NEAREST SITE: 0 miles
NEXT Oncology
San Antonio, TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04592484

Experimental Immunotherapy for Advanced Triple Negative Breast Cancer

A First-in-Human Study of CDK-002 (exoSTING) in Subjects With Advanced/Metastatic, Recurrent, Injectable Solid Tumors, With Emphasis on Squamous Cell Carcinoma of the Head and Neck, Triple Negative Breast Cancer, Anaplastic Thyroid Carcinoma, and Cutaneous Squamous Cell Carcinoma Scientific Title

Purpose
To determine the safety, side effects, and best dose of CDK-002 (exoSTING™) when injected directly into tumors.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least one chemotherapy, a PD-L1 inhibitor or a PD-1 inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK-002 (exoSTING™), by injection, directly into your tumor(s)</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">3 biopsies</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK-002 (exoSTING) is an experimental type of immunotherapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people 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/NCT04592484' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.codiakbio.com/pipeline-programs/exosting' target='_blank'>Codiak BioSciences Drug Information Page: CDK-002 (exoSTING)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/triple-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: Triple-Negative Breast Cancer Update</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
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17

NEAREST SITE: 0 miles
Hackensack University Medical Center
Hackensack, NJ

VISITS: 3-4 visits per month, for 6 months

PHASE: II

NCT ID: NCT05144698

RAPA-201 Immunotherapy for Advanced Triple Negative Breast Cancer

Phase II Trial of Autologous Rapamycin-Resistant Th1/Tc1 (RAPA-201) Cell Therapy of PD-(L)1 Resistant Solid Tumors Scientific Title

Purpose
To determine the safety of RAPA-201 T-cell immunotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumor has progressed on treatment with an anti-PD-L1 immunotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw for the collection of your white blood cells (an apheresis procedure) to be used for the personalized RAPA-201 cell therapy</li> <li class="seamTextUnorderedListItem">Standard-of-care chemotherapy, by IV, once a week for 3 out of every 4 weeks</li> <li class="seamTextUnorderedListItem">RAPA-201, by IV, once a month for 5 months </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">A hospital stay may be required.</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your white blood cells are modified in a lab so they can identify and attack cancer cells. These modified cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">The chemotherapy used in this study is carboplatin and paclitaxel.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05144698' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/breast-cancer-immunotherapy-clinical-trials/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>
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18

NEAREST SITE: 0 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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  • <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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19

NEAREST SITE: 0 miles
University of Utah, Huntsman Cancer Institute
Salt Lake City, UT

VISITS: 1 visit every 2 weeks, ongoing

PHASE: I-II

NCT ID: NCT03964532

Talazoparib and Avelumab for Advanced Breast Cancer (TALAVE)

TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of talazoparib (Talzenna®) when it is used along with avelumab (Bavencio®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have not already received a PARP inhibitor.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks, starting 1 month after Talazoparib</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat patients with an inherited BRCA mutation who have advanced HER2-negative breast cancer. </li> <li class="seamTextUnorderedListItem">Bavencio is a type of immunotherapy called a PD-L1 inhibitor. It is approved to treat certain types of lung 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/NCT03964532' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-talazoparib-gbrcam-her2-negative-locally-advanced-or-metastatic-breast-cancer' target='_blank'>FDA: FDA approves talazoparib to treat some advanced breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.practiceupdate.com/content/avelumab-is-clinically-active-and-safe-in-advancedmetastatic-breast-cancer/60403' target='_blank'>PracticeUpdate: Avelumab Is Clinically Active and Safe in Advanced/Metastatic Breast Cancer</a> </li></ul>
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20

NEAREST SITE: 0 miles
Sharp Healthcare
San Diego, CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04143711

Immunotherapy DF1001 Alone or With Keytruda® for IHC HER2 1+, 2+ or 3+ Metastatic Breast Cancer

A Phase I/II, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF1001 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications Scientific Title

Purpose
To study the safety, effects (good and bad), and best dose of DF1001 when it is given alone or with pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer that tests HER2 1+, 2+ or 3+ on the IHC (immunohistochemistry) tumor test and have not had more than three lines of chemotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DF1001 immunotherapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">You may also receive:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), 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">DF1001 is an experimental immunotherapy. </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a PD-L1 inhibitor. It is 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/NCT04143711' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/msi-h/' target='_blank'>Merck Oncology Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dragonflytx.com/copy-of-about-us-1' target='_blank'>Dragonfly Therapeutics Information Page: DF1001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6554437/' target='_blank'>Journal Article: Cancer Immunotherapy Based on Natural Killer Cells: Current Progress and New Opportunities</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/keytruda-approved-for-microsatellite-instability-high-and-mismatch-repair-deficient-cancers' target='_blank'>Cure Today: Keytruda Approved for Any Solid Tumor With a Specific Genetic Marker</a> </li></ul>
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21

NEAREST SITE: 0 miles
Sibley Memorial Hospital
Washington, DC

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

PHASE: II

NCT ID: NCT04837209

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or ER-Low Breast Cancer

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

Purpose
To study the safety and anti-cancer activity of giving radiation therapy with a PARP inhibitor and a PD-1 inhibitor.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer. You must not have received more than two systemic therapies for advanced disease and you must not have a BRCA 1/2 mutation (inherited or tumor).    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV, every 3 weeks for 3 months, then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Radiation therapy, 3 times, during the first week of treatment</li></ul>
  • <ul class="seamTextUnorderedList"> <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 breast cancer. </li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®)is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is considered an experimental drug in this trial. </li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is an experimental PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">An experimental therapy is a drug approved by the FDA for studying in people in clinical trials. A drug may be FDA approved for use in one disease but still considered experimental for use in breast cancer. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Researchers believe that radiation therapy may also boost the immune system, which will help the immune system go after and kill cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04837209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/triple-negative-breast-cancer-treatment-symptoms-research' target='_blank'>BCRF: Triple-Negative Breast Cancer: Symptoms, Treatment, Research</a> </li></ul>
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22

NEAREST SITE: 0 miles
The University of Chicago Medicine
Chicago, IL

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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  • <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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23

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

VISITS: 4 visits every 6 weeks, ongoing

PHASE: I

NCT ID: NCT03579472

Bintrafusp Alfa 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 bintrafusp alfa (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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  • <p class="seamTextPara"> You will receive: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bintrafusp Alfa (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">Bintrafusp alfa (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: Bintrafusp Alfa (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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24

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

VISITS: 1 visit every week to 2 weeks, ongoing

PHASE: II

NCT ID: NCT03202316

Atezolizumab, Cobimetinib & Eribulin for Metastatic Inflammatory Breast Cancer

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer Scientific Title

Purpose
To determine the safety and effects (good and bad) of a combination therapy including chemotherapy, immunotherapy, and targeted therapies.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) inflammatory breast cancer. If your cancer is HER2 positive (HER2+), you must have received at least two anti-HER2 therapies, including pertuzumab (Perjeta®) and trastuzumab emtansine/T-DM1 (Kadcyla®).    Full eligibility criteria
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  • <p class="seamTextPara"> You will receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">First 2 weeks</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, 8 times over 3.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), mouth, weekly (3 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. </li> <li class="seamTextUnorderedListItem">FDA has approved Tecentriq® to treat certain types of bladder and lung cancer. </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®) is a new targeted therapy called an MEK inhibitor. It is approved to treat certain types of melanoma. </li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy approved for treating 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/NCT03202316' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cobimetinib' target='_blank'>Wikipedia: Cobimetinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cotellic.com' target='_blank'>Genentech Information Page: Cotellic</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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25

NEAREST SITE: 0 miles
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, MD

VISITS: Every 2 weeks for 1 year

PHASE: I-II

NCT ID: NCT02484404

MEDI4736 with Lynparza or Cediranib for Advanced Triple Negative Breast Cancer

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer Scientific Title

Purpose
To study the safety and effects (good and bad) of giving MEDI4736 and Lynparza together.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer for whom no currently available treatment exists. You must not have received more than three prior therapies for metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> Participants 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">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MEDI4736 (duryalumab), by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (MEDI4736) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. </li> <li class="seamTextUnorderedListItem">Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02484404' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=740856' target='_blank'>NCI Drug Dictonary: MEDI4736</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=560191' target='_blank'>NCI Drug Dictonary: Olaparib</a> </li></ul>
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26

NEAREST SITE: 0 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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  • <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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27

NEAREST SITE: 0 miles
Baylor College of Medicine
Houston, TX

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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  • <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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28

NEAREST SITE: 0 miles
Research Site
Boston, MA

VISITS: Approximately 1 visit a week

PHASE: I-II

NCT ID: NCT03742102

Imfinzi & Taxol with Capivasertib, Danvatirsen or Oleclumab for First Line Metastatic TNBC

A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer. (BEGONIA) Scientific Title

Purpose
To look at the safety and effects (good and bad) of the combination of durvalumab (Imfinzi®) and paclitaxel (Taxol®) when used alone or with one of three additional therapies.
Who is this for?
Women with metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) being treated for the first time for metastatic disease.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 4 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Capivasertib (AZD5363), by mouth, twice a day, 3 weeks on and 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Danvatirsen (AZD9150), by IV, 3 times in the first week and then weekly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, monthly</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 weeks on and 1 week off</li> <li class="seamTextUnorderedListItem">Oleclumab (MEDI9447), by IV, once every 2 weeks for 1 month, then monthly</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Imfinzi is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain types of cancers, and its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxol is a chemotherapy routinely used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">The three additional therapies are capivasertib, a targeted therapy that blocks Akt; danvatirsen, a targeted therapy that blocks the STAT3 protein; and oleclumab, which targets CD73.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742102' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/asco-2019/capivasertib-combined-with-fulvestrant-improves-pfs-in-er-breast-cancer' target='_blank'>OncLive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/stat3-antisense-oligonucleotide-isis-481464' target='_blank'>NCI Drug Dictionary: Danvatirsen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd73-monoclonal-antibody-medi9447' target='_blank'>NCI Drug Dictionary: Oleclumab</a> </li></ul>
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29

NEAREST SITE: 0 miles
Rocky Mountain Cancer Center - Longmont
Longmont, CO

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03424005

Atezolizumab & Targeted Therapy or Chemotherapy for Metastatic Triple Negative Breast Cancer

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer (Morpheus-TNBC) Scientific Title

Purpose
To study the safety and effects (good and bad) of 7 different immunotherapy-based treatment combinations in people with triple negative (ER-/PR-/HER2-) breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer that progressed during or following first-line metastatic treatment with chemotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 7 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, once or twice every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily (3 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily (2 weeks on, 1 week off), ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 7</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Physician's choice chemotherapy (gemcitabine/Gemzar® plus carboplatin/Paraplatin®, or eribulin/Halaven®), by IV, weekly (2 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is atezolizumab (Tecentriq®). It is a PD-L1 inhibitor that works by stimulating the body's immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Tecentriq is approved to treat certain types of urinary, bladder and lung cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapies being used in the study are Ipatasertib (GDC-0068), SGN-LIV1A, bevacizumab (Avastin®) and cobimetinib (Cotellic®).</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are capecitabine (Xeloda®), gemcitabine (Gemzar®), carboplatin (Paraplatin®) and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a type of targeted therapy called an AKT inhibitor. It may slow or stop cancer cells from growing by blocking the enzyme (protein) AKT.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03424005' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>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><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li></ul>
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30

NEAREST SITE: 0 miles
Research Site
Commack, NY

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04556773

Trastuzumab Deruxtecan with other Therapies for Advanced HER2-Low Breast Cancer

A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08) Scientific Title

Purpose
To study the anti-cancer activity, safety, and side effects of giving trastuzumab deruxtecan (Enhertu®) with other therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer. If your disease is hormone-positive (ER+ and/or PR+), you must not have already received more than one line of anti-hormone therapy and no chemotherapy. If your disease is hormone-negative, you must not have received more than one line of chemotherapy.    Full eligibility criteria
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  • <p class="seamTextPara"> You will be assigned to 1 of 5 groups and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug used to treat advanced breast cancer.(Taxol®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, twice a day, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low breast cancer is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan is approved to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">The chemotherapy capecitabine (Xeloda®) is used to treat metastatic breast cancer that has stopped responding to other chemotherapies. </li> <li class="seamTextUnorderedListItem">Durvalumab (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, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">The chemotherapy paclitaxel (Taxol®) is used to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy that blocks the Akt protein. The Akt protein helps cancer cells divide and grow.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is a type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early-stage and metastatic hormone-positive (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04556773' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing, A New Subcategory of HER2-Negative Breast Cancer?</a> </li></ul>
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