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

Visit COVID-19 & Cancer Clinical Trials on Metastatic Trial Talk for regularly updated information about clinical trials during the coronavirus pandemic.

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(Last updated: January 11, 2022)

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

VISITS: 1 visit per week, ongoing

PHASE: II

NCT ID: NCT04461600

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

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

Purpose

To study the safety and anti-cancer activity of the experimental targeted therapy called AL101.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have had no more than three therapies for advanced or metastatic disease and whose tumor tests positive for a Notch pathway activation mutation. Your tumor will be tested for this mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AL101, by IV, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">AL101 is a type of experimental targeted therapy called a GSI (selective small molecule gamma secretase inhibitor).</li> <li class="seamTextUnorderedListItem">GSIs work by blocking Notch pathway activation.</li> <li class="seamTextUnorderedListItem">Notch activation will be determined by a Next Generation Sequencing (NGS) test as part of the study.</li> <li class="seamTextUnorderedListItem">Your doctor will be provided the full results of your NGS test.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Notch activating mutation/alterations</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04461600' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ayalapharma.com/pipeline/investigational-therapies-al101-and-al102' target='_blank'>Ayala Pharmaceuticals Drug Information Page: AL101</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.hindawi.com/journals/jo/2019/8707053/' target='_blank'>Hindawi Journal of Oncology: Notch Signaling Activation as a Hallmark for Triple-Negative Breast Cancer Subtype</a> </li></ul>

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

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04254107

Experimental SEA-TGT For Advanced Triple Negative Breast Cancer

A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies Scientific Title

Purpose

To study the dose, safety, side effects and anti-cancer activity of giving the experimental immunotherapy SEA-TGT.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-TGT, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-TGT is an experimental immunotherapy. </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/NCT04254107' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/clinical-trials/cls-20491268' target='_blank'>Mayo Clinic Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/clinical-trials' target='_blank'>Seagen Drug Information Page: SGN-TGT</a> </li></ul>

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

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT03971409

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

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

Purpose

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

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) or ER-Low (1%-10% ER) breast cancer who have not had more than three lines of chemotherapy and not more than one checkpoint inhibitor. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Binimetinib, by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Avelumab (Bavencio®), by IV, every 2 weeks</li> </ul> Group 2 <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> Group 3 <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>

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

VISITS: 4 visits over 2 months

PHASE: I

NCT ID: NCT03517488

XmAb20717 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb20717 in Subjects With Selected Advanced Solid Tumors (DUET-2) Scientific Title

Purpose

To test the safety, effects (good and bad) and best dose of an experimental immunotherapy called XmAb20717.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb20717, by IV, once every 2 weeks, for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb20717 blocks two proteins on immune cells, PD-1 and CTLA4. </li> <li class="seamTextUnorderedListItem">Blocking these proteins helps your immune system see and go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03517488' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793410' target='_blank'>NCI drug dictionary: XmAb20717</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/xencor-doses-first-patient-in-phase-1-study-of-xmab20717-dual-checkpoint-inhibitor-for-the-treatment-of-advanced-solid-tumors-300680374.html' target='_blank'>Xencor press release: XmAb20717</a> </li></ul>

NEAREST SITE: 3 miles
University of California at San Francisco ( Site 0004)
San Francisco,CA

VISITS: 3 visits per month, ongoing

PHASE: I

NCT ID: NCT03564691

MK-4830 With Pembrolizumab and Chemotherapy For Advanced Triple Negative Breast Cancer

A Phase 1 Open Label, Multi-Arm, Multicenter Study of MK-4830 as Monotherapy and in Combination With Pembrolizumab for Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety and anti-cancer activity of MK-4830 (a targeted therapy), pembrolizumab (immunotherapy) and chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have not yet started treatment for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">MK-4830, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly (3 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-4830 is a monoclonal antibody that targets the protein ILT4.</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">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/NCT03564691' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncozine.com/esmo-2020-first-in-class-mk-4830-antibody-targeting-ilt4-shows-promising-preliminary-results/' target='_blank'>ESMO 2020: MK-4830 Antibody Targeting ILT4 Shows Promising Preliminary Results</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Comprehensive Cancer Ctr
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03289962

Personalized Cancer Vaccine With or Without Atezolizumab for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using a personalized cancer vaccine (RO7198457) alone or with an immunotherapy drug (the PD-LI inhibitor atezolizumab).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Your cancer must have progressed after receiving standard of care therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The personalized cancer vaccine is called RO7198457. </li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) works by blocking the PD-L1 (programmed death-ligand 1) protein and is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</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/NCT03289962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq-hcp.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=791183' target='_blank'>NCI Drug Dictionary: RO7198457</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03454451

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

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

Purpose

To test the safety and effects (good and bad) of CPI-006 when it is given alone or with CPI-444 or with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options. Full eligibility criteria

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You will be randomly assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">CPI-444, by mouth, twice daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006, by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CPI-006 is an investigational immunotherapy that gets the immune system to after cancer cells by targeting CD73. </li> <li class="seamTextUnorderedListItem">CPI-444 is an investigational immunotherapy that targets the adenosine-A2A receptor (ADORA2A) on immune cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1. </li> <li class="seamTextUnorderedListItem">Keytruda is approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03454451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.2505' target='_blank'>Journal of Clinical Oncology: CPI-006, an anti-CD73 antibody with immune modulating activity, in a phase 1 trial in advanced cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/adenosine-a2a-receptor-antagonist-cpi-444' target='_blank'>NCI Drug Dictionary: adenosine-A2A receptor antagonist CPI-444</a> </li></ul>

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

VISITS: 1 to 4 visits monthly, ongoing

PHASE: I

NCT ID: NCT03829436

TPST-1120 Alone or With a Systemic Therapy in Advanced Triple Negative Breast Cancer

A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose and effects (good and bad) of TPST-1120 when it is used alone or with another anti-cancer drug.

Who is this for?

People with triple negative advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once a month</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, once every 3 weeks</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV, once a week</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TPST-1120 is an investigational drug that targets a protein called PPARα. </li> <li class="seamTextUnorderedListItem">The other drugs it may be given with are nivolumab (Opdivo®), docetaxel (Taxotere®), and cetuximab (Erbitux®). </li> <li class="seamTextUnorderedListItem">Opdivo is a type of immunotherapy called a PD-1 inhibitor. It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Taxotere is a chemotherapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Erbitux is a targeted therapy that blocks EGFR. It is approved to treat head, neck and colorectal cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03829436' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/reading-room/asco/breast-cancer/79947' target='_blank'>Medpage Today: Cetuximab in Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.esmo.org/Oncology-News/Promising-Response-Rates-in-Patients-with-Metastatic-TNBC-Treated-with-Nivolumab-After-Induction-Treatment' target='_blank'>ESMO: Promising Response Rates in Patients with Metastatic TNBC Treated with Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Breast Cancer Now: Docetaxel (Taxotere)</a> </li><li class='seamTextUnorderedListItem'><a href='http://cancerres.aacrjournals.org/content/79/13_Supplement/3606' target='_blank'>AACR Poster Session Abstract: TPST-1120 suppresses tumor growth and stimulates anti-tumor immunity</a> </li></ul>

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

VISITS: At least 1 visit every 2 months

PHASE: I-II

NCT ID: NCT03997968

CYT-0851 for Advanced Solid Tumors and Some Types of Blood Cancers

A Multi-Center, Open Label Phase 1/2 Study of CYT-0851, an Oral RAD51 Inhibitor, in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors Scientific Title

Purpose

To study the safety and best dose of CYT-0851, a type of targeted therapy called a RAD51 inhibitor.

Who is this for?

People with triple negative (ER-, PR-, HER2-) metastatic (stage IV) breast cancer that tests positive for a protein called activation-induced cytidine deaminase (AID). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CYT-0851, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RAD51 is a protein that helps cells repair DNA damage. Blocking this process may keep tumors from growing. </li> <li class="seamTextUnorderedListItem">Tumors that test positive for a protein called activation-induced cytidine deaminase (AID) may have high rates of DNA damage. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03997968' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/breast-cancer/rad51-linked-parp-inhibitor-resistance-brca-mutated-breast-cancer' target='_blank'>CancerNetwork.com: RAD51</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family CCC
San Francisco,CA

VISITS: 1-2 visits a month, ongoing

PHASE: I-II

NCT ID: NCT03280563

Immunotherapies, Targeted Therapies, and Anti-Estrogen Therapies for Advanced Hormone Positive, HER2 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 Hormone Receptor-Positive HER2-Negative Breast Cancer (MORPHEUS-HR+ Breast Cancer) Scientific Title

Purpose

To evaluate the safety, effects (good and bad), and anti-cancer activity of several therapy combinations that include immunotherapies, targeted therapies, and anti-estrogen therapies.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (ER+, HER2-) breast cancer. Your cancer must have recurred or progressed on your most recent treatment. Full eligibility criteria

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You will be assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">Entinostat, by mouth, once a week, ongoing</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) by injection or tamoxifen (Nolvadex®) or exemestane (Aromasin®) by mouth</li> </ul> Group 7 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, twice a month, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 1-2 times a month, ongoing</li> </ul> If your disease progresses while on treatment, you may be eligible to receive a new combination treatment. Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies may be required</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 checkpoint inhibitor. It is approved to treat locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Entinostat is an investigational type of targeted therapy called an HDAC inhibitor.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Ipatasertib (GDC-0068) is a new type of cancer drug that works by blocking the Akt protein</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin) is a monoclonal antibody that keeps tumors from growing by shrinking their supplying blood vessels. Avastin is used to treat HER2-negative metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03280563' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.biooncology.com/pipeline-molecules/ipatasertib.html' target='_blank'>Genentech Drug Information Page: Ipatasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/patients/medicines/tecentriq' target='_blank'>Genentech Drug Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/hormone-therapy/fulvestrant-faslodex' target='_blank'>Breast Cancer Now: Fulvestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/entinostat' target='_blank'>NCI Drug Dictionary: Entinostat</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/avastin' target='_blank'>Breastcancer.org: Avastin</a> </li></ul>

NEAREST SITE: 8 miles
Bay Area Breast Surgeons Inc
Emeryville,CA

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

PHASE: II

NCT ID: NCT04647916

Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity, safety and side effects of giving the antibody-drug conjugate sacituzumab govitecan (Trodelvy®) to treat brain metastases (breast cancer that has spread to the brain).

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain. Full eligibility criteria

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You will receive the following: <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. It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer.</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan 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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04647916' target='_blank'>ClinicalTrials.gov</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.targetedonc.com/view/sacituzumab-govitecan-shows-pfs-benefit-for-patients-with-mtnbc-and-brain-metastases' target='_blank'>Targeted Oncology: Sacituzumab Govitecan Shows PFS Benefit for Patients With mTNBC and Brain Metastases</a> </li></ul>

NEAREST SITE: 27 miles
Exelixis Clinical Site #21
Stanford,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03170960

Cabozantinib Alone or With Atezolizumab in Advanced Triple Negative Breast Cancer

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

Purpose

To assess the safety, best dose, and effects (good and bad) of cabozantinib (Cabometyx®) when it is used alone or with atezolizumab (Tecentriq®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has already been treated with at least one line of therapy. Full eligibility criteria

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What's involved?
What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabometyx is a targeted therapy that blocks some of the signals that tell cancer cells to grow and divide and that stimulate the blood vessels the cancer cells need grow. It is approved to treat kidney and liver cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called an immune checkpoint inhibitor. It is approved for use in combination with the chemotherapy Abraxane® (nab-paclitaxel) to treat advanced triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03170960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>Medlineplus: Cabozantinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.1026' target='_blank'>ASCOPubs.org: A phase II study of cabozantinib alone or in combination with trastuzumab in patients with breast cancer brain metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/atezolizumab-triple-negative-breast-cancer-fda-approval' target='_blank'>NCI: Atezolizumab Approved for Some Patients with TNBC</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University
Stanford,CA

VISITS: May require hospital stay

PHASE: I

NCT ID: NCT04282044

T cell Immunotherapy CRX100 for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose-Escalation Study of CRX100 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving an experimental immunotherapy made from cells from your own immune system.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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What's involved?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood draw to collect white blood cells to make the immunotherapy (leukapheresis)</li> <li class="seamTextUnorderedListItem">CRX100, by IV</li> </ul> A hospital stay may be required
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CRX100 is the name of the immunotherapy used in this trial. It may work by directly killing cancer cells and by getting the immune system to go after and kill cancer cells. </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/NCT04282044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bioeclipse.com/clinical-trials-overview/' target='_blank'>BioEclipse Therapeutics Drug Information Page: CRX1000</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/25381063/' target='_blank'>Journal Article Abstract: Cytokine-Induced Killer (CIK) Cells in Cancer Immunotherapy</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><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Leukapheresis' target='_blank'>Wikipedia: Leukapheresis</a> </li></ul>

NEAREST SITE: 27 miles
Stanford Cancer Institute
Stanford,CA

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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What's involved?
What's being studied?
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You will be randomly assigned to 1 of 7 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth (2 weeks on, 1 week off), ongoing </li> </ul> Group 2 <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> Group 3 <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> Group 4 <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> Group 5 <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> Group 6 <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> Group 7 <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></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>

NEAREST SITE: 27 miles
Stanford University Hospitals and Clinics
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02401347

Talazoparib for Advanced HER2 Negative Breast Cancer with Certain Mutations

A Phase II Clinical Trial of BMN 673 in BRCA1 and BRCA2 Wild-Type Patients With (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency as Assessed by the HRD Assay, and (ii) Advanced HER2-Negative Breast Cancer With Either a Germline or Somatic Mutation in... Scientific Title

Purpose

To study the safety and anti-cancer activity of the PARP inhibitor talazoparib (Talzenna®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that is HER2 negative (HER2-) and who have received at least one prior chemotherapy for metastatic disease. Your tumor must test positive for or express one of several markers. (See below for a list of targets and mutations.) You cannot enroll in this trial if you have an inherited BRCA 1 or BRCA 2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor that is approved to treat people with advanced or metastatic HER2 negative (HER2-) breast cancer and an inherited BRCA 1 or BRCA 2 mutation. </li> <li class="seamTextUnorderedListItem">You cannot enroll in this trial If you have an inherited BRCA 1 or BRCA 2 mutation.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Homologous Recombination Deficiency, PTEN, PALB2, CHEK2, ATM, NBN, BARD1, BRIP1, RAD50, Rad51c, Rad51d, MRE11, ATR, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, plus other HR-related genes at the discretion of the primary investigators.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02401347' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com' target='_blank'>Pfizer Oncology Information Page: Talazoparib</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University Medical Center
Palo Alto,CA

VISITS: 4 visits every 6 weeks for 2 years

PHASE: II

NCT ID: NCT03567720

Tavo & Pembrolizumab (Immunotherapy) in Advanced Triple Negative Tumors

A Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Intravenous Pembrolizumab Therapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study tumor response to and the effects (good and bad) of using Tavo-EP and pembrolizumab (Keytruda®) together to treat advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tavo-EP (tavokinogene telseplasmid, pIL-12), by electroporation, 3 times every 6 weeks, for 2 years</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It stimulates the body's immune system to go after cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved to treat certain types of cancers, and its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">Tumor infiltrating lymphocytes (TILs) are immune cells that have moved from the blood into a tumor cell. </li> <li class="seamTextUnorderedListItem">Studies have found that tumors with fewer TILs do not respond as well to immunotherapy.</li> <li class="seamTextUnorderedListItem">Tavo-EP (Tavoâ„¢) activates the immune system in a way that brings more TILs into the tumors. It is administered through electroporation, an electric current that makes it possible to put a drug or DNA into a cell. </li> <li class="seamTextUnorderedListItem">Researchers think using Tavo with Keytruda will make tumors more likely to respond to Keytruda.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03567720' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.oncosec.com/press-releases/detail/1942/oncosec-provides-highlights-from-research-reception-at-aacr' target='_blank'>OncoSec: Press Release (Tavo-EP)</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncosec.com/wp-content/uploads/2018/06/SITC-2017-Poster-Handout.pdf' target='_blank'>OncoSec: Poster Summary (Tavo-EP)</a> </li></ul>

NEAREST SITE: 28 miles
Stanford Cancer Center
Palo Alto,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03621982

ADCT-301 in Advanced Triple Negative Breast Cancer

A Phase 1b, Open-Label, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Camidanlumab Tesirine (ADCT-301) in Patients With Selected Advanced Solid Tumors Scientific Title

Purpose

To compare the safety and effects (good and bad) of ADCT-301, a targeted therapy that combines the monoclonal antibody HuMax-TAC with a new type of chemotherapy called PBD.

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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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADCT-301 is a new type of targeted therapy that combines the monoclonal antibody HuMax-TAC with a new type of chemotherapy called PBD. </li> <li class="seamTextUnorderedListItem">The monoclonal antibody brings the chemotherapy directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of advanced cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03621982' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/editorial/adct-301-a-novel-antibody-drug-conjugate-against-lymphomas-moves-into-phase-i-clinical-trial/' target='_blank'>ADC Review: ADCT-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/2019/02/05/phase-1b-trial-of-adct-301-in-advanced-solid-tumors-dosed-first-patient/' target='_blank'>Immuno-Oncology News: ADCT-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 53 miles
St. Joseph Heritage Healthcare
Santa Rosa,CA

VISITS: 1 visit every 3 weeks, for 2 years

PHASE: I-II

NCT ID: NCT03761914

Immunotherapy Galinpepimut-S and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers Scientific Title

Purpose

To assess the safety, effects (good and bad) and best dose of the immunotherapy galinpepimut-S when it is used along with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options. Full eligibility criteria

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You will be given the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GM-CSF, by injection, before Galinpepimut-S</li> <li class="seamTextUnorderedListItem">Galinpepimut-S, by injection, every 3 weeks, for up to 2 years</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Galinpepimut-S is a vaccine that targets the protein WT1. </li> <li class="seamTextUnorderedListItem">Higher than normal amounts of this protein are found on the surface of breast and certain other cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03761914' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sellaslifesciences.com/galinpepimut-s-gps-therapy/' target='_blank'>Trial Sponsor Sellas Lifescience: Galinpepimut-S Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/galinpepimut-s/' target='_blank'>Immuno-Oncology News: Galinpepimut-S</a> </li><li class='seamTextUnorderedListItem'><a href='https://pharmaphorum.com/views-and-analysis/asco-2017-breast-cancer-keytruda/' target='_blank'>Pharmaphorum: ASCO 2017: Breast cancer next target for Keytruda</a> </li></ul>

NEAREST SITE: 53 miles
St Jude Hospital dba St Joseph /ID# 211130
Santa Rosa,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03893955

ABBV-927 and ABBV-368 for Advanced Triple Negative Breast Cancer

A Phase 1, Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-927 and ABBV-368 With and Without ABBV-181 in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety and effects (good and bad) of using two experimental immunotherapies, ABBV-927 and ABBV-368, together.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not been treated with an immunotherapy and that did not respond to at least one systemic therapy that included a taxane. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-927, by IV</li> <li class="seamTextUnorderedListItem">ABBV-368, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-927 is an immunotherapy that gets the immune system to go after cancer cells by targeting a protein called CD40. </li> <li class="seamTextUnorderedListItem">ABBV-368 is an immunotherapy that targets OX40, which is found on certain T cells. </li> <li class="seamTextUnorderedListItem">This study is also recruiting 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/NCT03893955' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-cd40-agonist-monoclonal-antibody-abbv-927' target='_blank'>NCI Drug Dictionary: ABBV-927</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-368.html' target='_blank'>Drug company information page: ABBV-368</a> </li></ul>

NEAREST SITE: 74 miles
University of California Davis Comprehensive Cancer Center
Sacramento,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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You will be randomly assigned to 1 of 2 groups: Group 1: Vaccine <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> followed by: <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> Group 2: No Vaccine <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> followed by: <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 CTLA4 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>

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

VISITS: 1 visit every 3 weeks

PHASE: II

NCT ID: NCT02849496

Olaparib Alone or With Atezolizumab for People With Advanced HER2 Negative Breast Cancer & an Inherited or Tumor BRCA1/2 Mutation

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To compare the anti-cancer activity of the targeted therapy olaparib (Lynparza®) when it is given alone to when it is given in combination with the immunotherapy atezolizumab (Tecentriq®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer who have an inherited BRCA 1 or BRCA 2 mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsies</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) 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.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is approved to treat HER2 negative (HER2-) metastatic breast cancer in women with a BRCA 1/2 genetic mutation.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-LI inhibitor. It works by getting the immune system to go after cancer cells by blocking a protein called PD-L1 (programmed death ligand-1). </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is approved for use in advanced triple negative breast cancer. Its use in this trial 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/NCT02849496' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lynparza.com' target='_blank'>AstraZeneca Drug Information Page: Lynparza® (Olaparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-breast-cancer-treatment/parp-inhibitors-in-breast-cancer-treatment' target='_blank'>Breast Cancer Now: PARP Inhibitors in Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Drug Information Page: Tecentriq® (Atezolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>

NEAREST SITE: 250 miles
Comprehensive Blood and Cancer Center Dept. of CBCC (2)
Bakersfield,CA

VISITS: 1 visit a week, ongoing

PHASE: III

NCT ID: NCT04251533

Chemotherapy Alone or with Alpelisib for Advanced Triple Negative Breast Cancer with a PIK3CA Mutation or PTEN Loss

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (EPIK-B3) Scientific Title

Purpose

To compare the safety and anti-cancer activity of giving the chemotherapy nab-paclitaxel (Abraxane®) alone or in combination with the targeted therapy Alpelisib (Piqray®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumors test positive for a PIK3CA mutation or PTEN loss and who have not received more than one chemotherapy for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy approved to treat advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) blocks the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA and PTEN loss</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04251533' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib</a> </li></ul>

NEAREST SITE: 273 miles
Samsum Clinic
Santa Barbara,CA

VISITS: 3 visits per month, ongoing

PHASE: II

NCT ID: NCT03961698

IPI-549, Atezolizumab, and Nab-paclitaxel for Advanced Triple Negative Breast Cancer

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

Purpose

To study the effects of IP-549 when it is used with atezolizumab (Tecentriq®) and paclitaxel (Abraxane®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-,PR-,HER2-) breast cancer that has not been treated with chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IPI-549, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IP-549 is a type of experimental targeted therapy called a PI3K-gamma inhibitor. </li> <li class="seamTextUnorderedListItem">Tecentriq is a type of immunotherapy called a PD-L1 checkpoint inhibitor. It is approved to treat locally advanced or metastatic triple-negative, PD-L1-positive breast cancer. </li> <li class="seamTextUnorderedListItem">Abraxane is a chemotherapy used to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03961698' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.infi.com/home/our-development-program/ipi-549/' target='_blank'>Drug Company Information Page: IPI-549</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com/sclc.html?c=pdl-16d97f8fb9c&gclid=Cj0KCQiAtrnuBRDXARIsABiN-7Ap43URSS2rpiy3bh9KrbUqV-3pLCuvw7edYCY1v2MKoHoTdD369TUaArAsEALw_wcB&gclsrc=aw.ds' target='_blank'>Genentech Information Page: Tecentriq®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abraxane.com' target='_blank'>Drug Company Information Page: Abraxane®</a> </li></ul>

NEAREST SITE: 273 miles
Sansum Clinic
Santa Barbara,CA

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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You will be randomly assigned to 1 of 2 groups: Group 1: Trilaciclib and chemotherapy <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> Group 2: Placebo and chemotherapy <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>

NEAREST SITE: 336 miles
University of California, Los Angeles (UCLA)
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04115306

Targeted Therapy PMD-026 for Metastatic Triple Negative Breast Cancer

Phase 1/1b Multicenter, Open-Label, First-in-Human Dose Escalation and Dose Expansion Study to Assess Safety and Tolerability of Orally Administered PMD-026 in Patients With Metastatic Breast Cancer With Expansion in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To determine the best dose, safety, and effects of the drug PMD-026.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no standard treatment options. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PMD-026 is an experimental therapy that targets RSK2, a protein that plays a role in cancer cell growth.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04115306' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://phoenixmd.ca/pipeline' target='_blank'>Drug Company Information Page: PMD-026</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/29498411' target='_blank'>PubMed Abstract: RSK1 Promotes Murine Breast Cancer Growth and Metastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Ribosomal_s6_kinase' target='_blank'>Wikipedia: RSK</a> </li></ul>

NEAREST SITE: 336 miles
University of California, Los Angeles
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03401385

DS-1062a in Advanced Triple Negative Breast Cancer

Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of DS-1062a.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a</li> <li class="seamTextUnorderedListItem">2 biopsies</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DS-1062a is an investigational antibody-drug conjugate (ADC). This type of drug 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 Trop-2 proteins. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03401385' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793720' target='_blank'>NCI Drug Dictionary: DS-1062a</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 336 miles
UCLA Hematology & Oncology Clinic
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03849469

XmAb®22841 and Pembrolizumab in Advanced Triple Negative Breast Cancer

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®22841 Monotherapy and in Combination With Pembrolizumab in Subjects With Selected Advanced Solid Tumors (DUET-4) Scientific Title

Purpose

To determine the best dose, safety and effects of XmAb22841 when it is used alone or in combination with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®22841</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb®22841</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb22841 is a new type of immunotherapy that targets CTLA-4 and LAG-3. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to certain types of cancers. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03849469' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.xencor.com/pipeline/' target='_blank'>Drug company information page: XmAb®22841</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/latest-news/fda-approves-keytruda-pembrolizumab-for-any-tumor-with-specific-genetic-change.html' target='_blank'>Cancer.org: FDA Approves Keytruda (Pembrolizumab) for Any Tumor with Specific Genetic Change</a> </li></ul>

NEAREST SITE: 336 miles
University of California Los Angeles (UCLA).
Los Angeles,CA

VISITS: 2 visits a month, for as long as benefit is shown

PHASE: I

NCT ID: NCT03667716

COM701 Immunotherapy for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Study of COM701 as Monotherapy and In Combination With an Anti-PD-1 Antibody in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity, best dose, and side effects of giving COM701 alone or in combination with nivolumab (Opdivo®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer who have already received at least one chemotherapy for advanced disease and a PARP inhibitor if they have an inherited BRCA1/2 mutation. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">COM701, by IV, once every 4 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">COM701, by IV, once every 4 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">COM701 is an experimental immunotherapy that targets the PVRIG pathway. </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03667716' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cgen.com/clinical-trials/' target='_blank'>Compugen Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pvrig-monoclonal-antibody-com701' target='_blank'>NCI Drug Dictionary: COM701</a> </li></ul>

NEAREST SITE: 338 miles
Sarcoma Oncology Research Center LLC
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04293094

AMG 650 for People With Advanced Triple Negative Breast Cancer

A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and best dose of the experimental drug AMG 650.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have had at least one chemotherapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: AMG 650, by mouth, ongoing
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04293094' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 338 miles
Sarcoma Oncology Research Center
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03422679

Experimental Targeted Therapy CB-103 for Advanced Triple Negative Breast Cancer

A Phase I/IIA, Multi-Centre, Open-Label, Dose-Escalation Study With Expansion Arms to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CB-103 Administered Orally in Adult Patients With Advanced or Metastatic Solid Tumours and Haematological Malignancies Characterised by Alterations of the NOTCH Signalling Pathway (NC... Scientific Title

Purpose

To study the safety, side effects, and anti-cancer activity of the experimental targeted therapy CB-103 that can be taken by mouth.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CB-103, by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CB-103 is a NOTCH pathway inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03422679' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cellestia.com/the-pipeline/' target='_blank'>Cellestia Drug Information Page: CB-103</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/10.1200/JCO.2018.36.15_suppl.TPS2619' target='_blank'>ASCO Abstract: CB-103</a> </li></ul>

NEAREST SITE: 339 miles
UCLA David Geffen
Santa Monica,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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You will be assigned to 1 of 3 groups and receive the following: Group 1: Hormone positive, HER2 negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-2009, by IV, every 3 weeks, ongoing</li> </ul> Group 2: Triple negative, CD166 expression <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-2009, by IV, every 3 weeks, ongoing</li> </ul> Group 3: Triple negative, PD-L1 positive <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>

NEAREST SITE: 339 miles
University of California, Los Angeles JCCC Clinical Research Unit
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03674567

Immunotherapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer Scientific Title

Purpose

To look at the best dose, safety and effects (good and bad) of using FLX475 alone or with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FLX475 is an investigational targeted therapy that helps the immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 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/NCT03674567' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.flxbio.com/next-generation-immune-modulators/flx475/' target='_blank'>Sponsor site: FLX475</a> </li></ul>

NEAREST SITE: 339 miles
UCLA School of Medicine
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT01351103

LGK974 and PDR001 for Advanced Triple Negative Breast Cancer

A Phase I, Open-label, Dose Escalation Study of Oral LGK974 in Patients With Malignancies Dependent on Wnt Ligands Scientific Title

Purpose

To study the best dose and effects (good and bad) of using the experimental targeted therapy LGK974 (WNT974) in combination with the experimental immunotherapy PDR001 (spartalizumab).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer with no other treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LGK974 (WNT974), by mouth</li> <li class="seamTextUnorderedListItem">PDR001 (spartalizumab), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Wnt pathway is a network of proteins that may play a role in how cancer develops. </li> <li class="seamTextUnorderedListItem">LGK974 (WNT974) is a targeted therapy designed to inhibit the Wnt pathway.</li> <li class="seamTextUnorderedListItem">PDR001 (spartalizumab) is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced or metastatic cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01351103' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/publications/cancer-frontline/phase-i-clinical-trial-shows-wnt974-in-combination-with-spartalizumab-well-tolerated-for-advanced-solid-tumor-patients.h00-159381156.html' target='_blank'>MD Anderson Cancer Center: Phase I clinical trial shows WNT974 in combination with spartalizumab well tolerated for advanced solid tumor patients</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/porcupine-inhibitor-wnt974' target='_blank'>NCI Drug Dictionary: LGK974 (WNT974)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: PDR001 (Spartalizumab)</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03665285

NC318 for Advanced Triple Negative Breast Cancer

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

Purpose

To study the best dose, safety, and effects (good and bad) of an experimental cancer drug called NC318.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that has low levels of the protein PD-L1 and who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NC318, by injection</li> </ul> Please contact research site for treatment schedule Additional procedures <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>

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

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT04025216

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

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

Purpose

To study the safety, best dose, side effects (good and bad), and anti-cancer activity of a new CAR-T cell immunotherapy that targets cancer cells that test positive for MUC1.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for the antigen TnMUC1. Full eligibility criteria

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

NEAREST SITE: 339 miles
UCLA Department of Medicine - Hematology/Oncology
Santa Monica,CA

VISITS: Number of visits unavailable, ongoing

PHASE: I-II

NCT ID: NCT03729596

Targeted Therapy MGC018 Alone or with Immunotherapy MGA012 in Advanced Triple Negative Breast Cancer

A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad) and anti-cancer activity of the experimental antibody-drug conjugate MC108 given alone or given with the experimental PD-1 inhibitor MGA012.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have already received at least one therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC018, by IV, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGC018, by IV, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, ongoing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MC108 is an experimental antibody-drug conjugate (ADC)--it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells.</li> <li class="seamTextUnorderedListItem">In MC108, the antibody targets B7-H3 proteins and delivers the chemotherapy duocarmycin.</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor or PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">Blocking PD-1 allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This 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/NCT03729596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mgc018-b7-h3/' target='_blank'>MacroGenics Drug Information Page: MGC018</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3071' target='_blank'>ASCO Abstract: MGC018 (anti-B7-H3 antibody-drug conjugate) in Patients with Advanced Solid Tumors.</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Duocarmycin' target='_blank'>Wikipedia: Duocarmycin</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>MacroGenics Drug Information Page: MGA012 (Retifanlimab)</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Hematology/Oncology - Santa Monica
Santa Monica,CA

VISITS: Weekly visits for 2 months, monthly visits thereafter

PHASE: II

NCT ID: NCT03519178

PF-06873600 for Metastatic HER2-Negative Breast Cancer

Phase 1/2a Dose Escalation And Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics And Anti-tumor Activity Of Pf-06873600 As A Single Agent And In Combination With Endocrine Therapy Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of PF-06873600, a new targeted therapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor (ER+ and/or PR+) positive, HER2 negative (HER2-) breast cancer who have already received a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600, by mouth</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600, by mouth</li> <li class="seamTextUnorderedListItem">Endocrine therapy</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06873600 is a cyclin-dependent kinase (CDK) inhibitor. </li> <li class="seamTextUnorderedListItem">It works by inhibiting the CDK enzymes that help cancer cells grow. </li> <li class="seamTextUnorderedListItem">Patients in the study with hormone-receptor positive breast cancer will also be treated with an anti-estrogen therapy.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03519178' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793673' target='_blank'>NCI Drug Dictionary: PF-06873600</a> </li></ul>

NEAREST SITE: 340 miles
Valkyrie Clinical Trials
Los Angeles,CA

VISITS: 2 visits every 3 weeks, ongoing

PHASE: II

NCT ID: NCT05113966

Trilaciclib and Sacituzumab Govitecan for Advanced Triple Negative Breast Cancer

Trilaciclib Administered Prior to Sacituzumab Govitecan-hziy in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments, at Least One in the Metastatic Setting Scientific Title

Purpose

To study the safety and effects (good and bad) of giving trilaciclib (Cosela), a CDK 4/6 inhibitor, with sacituzumab govitecan-hziy (Trodelvy®).

Who is this for?

People with advanced (stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer and received at least two prior treatments. Full eligibility criteria

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What's being studied?
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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela) by IV, 2 out of every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) by IV, 2 out of every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trilaciclib (Cosela) is a type of targeted therapy called a CDK 4/6 inhibitor. </li> <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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05113966' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/fda-grants-trilaciclib-plus-chemotherapy-fast-track-designation-for-locally-advanced-or-metastatic-tnbc' target='_blank'>CancerNetwork: FDA Grants Trilaciclib Plus Chemotherapy Fast Track Designation for Locally Advanced or Metastatic TNBC</a> </li></ul>

NEAREST SITE: 341 miles
Cedars-Sinai Medical Center
West Hollywood,CA

VISITS: Number of visits unavailable, ongoing

PHASE: I

NCT ID: NCT04580485

INCB106385 Alone or With an Experimental Immunotherapy for Advanced Triple Negative Breast Cancer with a Certain Biomarker

A Phase 1, Open-Label, Multicenter Study of INCB106385 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, side effects and anti-cancer activity of giving the experimental therapy INCB106385 alone or with the experimental immunotherapy INCMGA00012.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard of care treatment options available and who have CD8 T-cell positive tumors. Full eligibility criteria

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What's being studied?
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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB106385, by mouth, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INCB106385, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">INCMGA00012, by IV, every month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <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/NCT04580485' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.incyte.com/what-we-do/pharmaceutical-portfolio' target='_blank'>Incyte Drug Information Page</a> </li></ul>

NEAREST SITE: 341 miles
Cedars Sinai Medical Center / Samuel Oschin Comprehensive Cancer Institute
Los Angeles,CA

VISITS: Visits every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03310957

SGN-LIV1A and Immunotherapy for Advanced Triple Negative Breast Cancer

Single Arm, Open Label Phase 1b/2 Study of SGN-LIV1A in Combination With Pembrolizumab for First-Line Treatment of Patients With Unresectable Locally-Advanced or Metastatic Triple-Negative Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using SGN-LIV1A--an experimental antibody-drug conjugate--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-) breast cancer who have not already received chemotherapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SGN-LIV1A, by IV, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">SGN-LIV1A is an antibody-drug conjugate. Its antibody targets LIV-1 (SLC39A6), a protein that is expressed by most breast cancer cells, and it delivers an anti-cancer drug called monomethyl auristatin E.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy drug called a PD-1 inhibitor. It blocks the PD-1 (programmed cell death-1) protein, making it possible for the body's immune system to go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03310957' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.seagen.com/science/pipeline/ladiratuzumab-vedotin' target='_blank'>Seagen Drug Information Page: Ladiratuzumab Vedotin (SGN-LIV1A)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 341 miles
Research Site
West Hollywood,CA

VISITS: 3 visits a month for at least 6 months

PHASE: III

NCT ID: NCT03997123

Capivasertib & Paclitaxel as First Line Treatment for Advanced Triple Negative Tumors

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC. (CapItello290) Scientific Title

Purpose

To compare the effects (good and bad) and effectiveness of paclitaxel (Taxol®) and capivasertib to paclitaxel (Taxol®) and a placebo.

Who is this for?

People who are receiving their first treatment for advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib, by mouth, 4 times a week, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on, 1 week off, for at least 6 months</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, 4 times a week, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, once a week, 3 weeks on, 1 week off, for at least 6 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy that is used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Capivasertib is a targeted therapy drug that blocks Akt.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03997123' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/akt-inhibitor-azd5363' target='_blank'>NCI Drug Dictionary: Capivasertib</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'>Oncolive: Capivasertib Combined With Fulvestrant Improves PFS in ER+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/80249' target='_blank'>Medpage Today: AKT Inhibitor Doubles PFS in Advanced Breast Cancer</a> </li></ul>

NEAREST SITE: 348 miles
Research Site
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02264678

Ceralasertib Alone or With Chemotherapy or With Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies. Scientific Title

Purpose

To study the safety, effects, and best dose of Ceralasertib when it is used alone or with the chemotherapy carboplatin or the PARP inhibitor olaparib (Lynparza®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1: Open to all MBC patients <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 4.5 months</li> </ul> Group 2: Open to all MBC patients <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth</li> </ul> Group 3: Open to Triple Negative Breast Cancer MBC patients with or without a BRCA mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib is a new type of targeted therapy called an ATR inhibitor. </li> <li class="seamTextUnorderedListItem">It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. </li> <li class="seamTextUnorderedListItem">Carboplatin is a chemotherapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor approved to treat BRCA 1 or BRCA 2 positive 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/NCT02264678' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: Ceralasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/olaparib' target='_blank'>NCI Drug Dictionary: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/targeting-cancers-achilles-heel-dna-damage-response-networks-beyond-parp' target='_blank'>OncLive: DNA Damage Response Networks Beyond PARP</a> </li></ul>

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

VISITS: 1 visit every 2 weeks for up to 3 months

PHASE: I

NCT ID: NCT05081492

CF33-hNIS-antiPDL1 Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase I, First-in-Human Study of Intratumoral Administration of CF33-hNIS-antiPDL1, A Novel Chimeric Oncolytic Poxvirus Encoding Human Sodium Iodide Symporter (HNIS) in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety, side effects, and best dose of CF33-hNIS-antiPDL1, an experimental immunotherapy.

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 two treatments for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CF33-hNIS-antiPDL1, by injection, every 2 weeks for up to 3 months.</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oncolytic viruses are a form of immunotherapy that uses viruses to infect and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">CF33-hNIS-antiPDL1 is an oncolytic virus.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05081492' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearch.org/en-us/immunotherapy/treatment-types/oncolytic-virus-therapy' target='_blank'>Cancer Research Institute.org: Oncolytic Virus Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.valdostadailytimes.com/news/business/city-of-hope-opens-oncolytic-virus-clinical-trial-for-patients-with-advanced-breast-cancer/article_d26fa7ed-8363-5805-a05a-d724a3fe374b.html' target='_blank'>Valdosta Daily Times: City of Hope Opens Oncolytic Virus Clinical Trial for Patients With Advanced Breast Cancer</a> </li></ul>

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

VISITS: 2 visits every 3 weeks, ongoing

PHASE: I

NCT ID: NCT02996825

Mirvetuximab Soravtansine & Chemotherapy in FRa+ Metastatic Triple Negative Breast Cancer

A Phase I Dose-Escalation Safety and Tolerability Study of Mirvetuximab Soravtansine (IMGN853) and Gemcitabine in Patients With FRa-positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial Cancer, or Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose

To test the safety and effects (good and bad) of a new drug called mirvetuximab soravtansine when it is given with the chemotherapy gemcitabine (Gemzar®).

Who is this for?

People with stage IV metastatic breast cancer that is triple negative (ER-, PR- and HER2-) and folate receptor (FR) alpha-positive. You must not have had more than four lines of chemotherapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mirvetuximab soravtansine, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine/Gemzar®, by IV, twice every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mirvetuximab soravtansine is an antibody drug conjugate (ADC). </li> <li class="seamTextUnorderedListItem">It uses a drug that targets folate receptors on cancer cells to deliver the chemotherapy soravtansine directly to the tumor. </li> <li class="seamTextUnorderedListItem">Gemzar® is a chemotherapy approved to treat metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of FR+ tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02996825' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/mirvetuximab-soravtansine' target='_blank'>NCI Dictionary: Mirvetuximab Soravtansine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/gemcitabine-hydrochloride' target='_blank'>NCI Dictionary: Gemcitabine Hydrochloride</a> </li></ul>

NEAREST SITE: 353 miles
Research Site
Duarte,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05123482

AZD8205 for Advanced Triple Negative BreastCancer

A Phase I/IIa Multi-center, Open-label Master Protocol to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of AZD8205 in Participants With Advanced or Metastatic Solid Malignancies Scientific Title

Purpose

To determine the safety, side effects, dose, and anti-cancer activity of AZD8205, and antibody-drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. You must not have received more than one line of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD8205, by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can 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/NCT05123482' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope
Duarte,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04699630

Antibody-Drug Conjugate U3-1402 for Advanced HER2 Negative Breast Cancer

A Phase II Study of U3-1402 in Patients With Metastatic Breast Cancer Scientific Title

Purpose

To study the safety, anti-cancer activity, and side effects of the investigational antibody-drug conjugate (ADC) U3-1402.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. If your cancer is triple-negative (ER-, PR-, HER2-), you must have already received at least one but no more than three chemotherapies for metastatic disease. If your cancer is hormone-positive (ER+ and/or PR+), you must not have received more than two chemotherapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">U3-1402, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibody-drug conjugates (ADCs) are therapies that contain an antibody linked to a specific type of chemotherapy. They are designed to deliver high doses of chemotherapy to cancer cells while sparing normal cells. </li> <li class="seamTextUnorderedListItem">U3-1402 is an investigational antibody-drug conjugate -- this means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">U3-1402 targets HER3 to deliver chemotherapy directly to cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04699630' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/patritumab-deruxtecan' target='_blank'>NCI Drug Dictionary: U3-1402</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.annalsofoncology.org/article/S0923-7534(19)30419-3/fulltext' target='_blank'>Annals of Oncology: Single Agent Activity of U3-1402</a> </li></ul>

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

VISITS: 1 visit every 2 weeks, for 2 months

PHASE: I

NCT ID: NCT03752398

XmAb23104 for Advanced Triple Negative Breast Cancer (DUET-3)

A Phase 1 Multiple-Dose Study to Evaluate the Safety and Tolerability of XmAb®23104 in Subjects With Selected Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad) and the best dose of an experimental immunotherapy called XmAb23104.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-) that has not responded to other treatment options. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb23104, by IV, every 2 weeks, for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XmAb23104 targets both PD-1 (programmed cell death protein 1) and ICOS (inducible T-cell co-stimulator). </li> <li class="seamTextUnorderedListItem">This study is enrolling people with other types of metastatic cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03752398' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/796973' target='_blank'>NCI drug dictionary: XmAb23104</a> </li></ul>

NEAREST SITE: 441 miles
UC San Diego Moores Cancer Center
La Jolla,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT02498613

Cediranib and Lynparza for Metastatic Triple Negative Breast Cancer

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors Scientific Title

Purpose

To study the effects (good and bad) and the anti-cancer activity of combining the PARP inhibitor olaparib (Lynparza®) with the targeted therapy cediranib.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. You must have received one prior therapy for your cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. </li> <li class="seamTextUnorderedListItem">Cediranib is a type of drug called an angiogenesis inhibitor. </li> <li class="seamTextUnorderedListItem">Giving cediranib with olaparib may make the olaparib more effective.</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/NCT02498613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medscape.com/viewarticle/891245' target='_blank'>Medscape: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cediranib' target='_blank'>Wikipedia: Cediranib</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

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

VISITS: Monthly visits for 1 year

PHASE: II

NCT ID: NCT03801369

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

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

Purpose

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

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer. Full eligibility criteria

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You will receive the following: <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> Additional procedures: <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>

NEAREST SITE: 533 miles
Oregon Health Oregon Health & Sciences University-Knight Cancer Institute
Portland,OR

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05006794

GS-9716 With Docetaxel or Sacituzumab Govitecan for Advanced Triple Negative Breast Cancer

A Phase 1a/b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GS-9716 as Monotherapy and in Combination With Anticancer Therapies in Subjects With Solid Malignancies Scientific Title

Purpose

To study the best dose, safety, and side effects of the experimental targeted therapy GS-9716.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer. You must have received one line of therapy for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-9716, by mouth</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy commonly used to treat breast cancer. (Taxotere®), by IV</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-9716, by mouth</li> <li class="seamTextUnorderedListItem">Sacituzumab Govitecan-hziy (Trodelvy®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GS-9716 is an experimental targeted therapy called an MCL-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy commonly used to treat breast cancer.</li> <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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05006794' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 538 miles
Providence Oncology & Hematology Care Clinic - Eastside
Portland,OR

VISITS: 1 visit every 2 weeks

PHASE: II

NCT ID: NCT03650894

Nivolumab with Ipilimumab and Bicalutamide for Advanced HER2- Breast Cancer

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

Purpose

To test the safety and effects (good and bad) of using a combination of nivolumab (Opdivo®), ipilimumab (Yervoy®), and bicalutamide (Casodex®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) HER2 negative breast cancer. Full eligibility criteria

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

NEAREST SITE: 538 miles
Providence Portland Medical Center ( Site 0001)
Portland,OR

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT04521621

Experimental Immunotherapy V937 and Pembrolizumab for Advanced Breast Cancer

A Phase 1b/2 Clinical Study of Intratumoral Administration of V937 in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the anti-cancer activity, safety and effects (good and bad) of giving the targeted immunotherapy V937 (CAVATAK®) along with the PD-1 inhibitor pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with either triple negative (ER-, PR-, HER2-) breast cancer and a tumor that can be reached for injection, or a metastatic tumor in your liver. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">V937 (CAVATAK®), injected directly into your tumor, 8 times over 6.5 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">V937 (CAVATAK®) is an oncolytic virus--this means it targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">V937 is injected directly into the tumor.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat only certain types of breast cancer, and its use in this trial is considered experimental.</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/NCT04521621' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.viralytics.com/our-pipeline/cavatak/cavataktm/' target='_blank'>Viralytics Drug Information Page: CAVATAK® (V937)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/coxsackievirus-v937' target='_blank'>NCI Drug Dictionary: V937 (Coxsackievirus A21)</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><li class='seamTextUnorderedListItem'><a href='https://www.google.com/search?q=keytruda&oq=keytruda&aqs=chrome..69i57j0i433l2j0l5.1621j0j7&sourceid=chrome&ie=UTF-8' target='_blank'>Merk Oncology Drug Information Page: Keytruda® (Pembrolizumab</a> </li></ul>

NEAREST SITE: 602 miles
Huntsman Cancer Institute
Salt Lake City,UT

VISITS: 5 visits a month, ongoing

PHASE: I

NCT ID: NCT04315233

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By Genomics (CHARGE) Scientific Title

Purpose

To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of cancer, but its use in breast cancer is considered experimental. </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/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</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>

NEAREST SITE: 602 miles
University of Utah School of Medicine Huntsman Cancer Institute
Salt Lake City,UT

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04432857

AN0025 and Pembrolizumab for Advanced Triple Negative Breast Cancer

An Open-Label Multicenter Phase Ib Study of AN0025 in Combination With Pembrolizumab in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity, and side effects of combining the experimental targeted therapy AN0025 with the immunotherapy pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than 3 prior therapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AN0025, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AN0025 is an experimental targeted therapy. This means it is only available in clinical trials.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor/checkpoint inhibitor. It is approved for use in other cancers but its use for breast cancer is considered experimental. </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/NCT04432857' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.adlainortye.com/en_product.php' target='_blank'>Adlai Nortye Drug Information Page: AN0025</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/keytruda-plus-chemo-better-than-chemo-alone-for-some' target='_blank'>Breastcancer.org: Keytruda Plus Chemotherapy Offers More Benefits Than Chemo Alone as First Treatment for Metastatic Triple-Negative Breast Cancer With High Levels of PD-L1</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor+KEYTRUDA+ONLY_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=Cj0KCQjwpNr4BRDYARIsAADIx9zN_JT9uThoV9MYlllBnCVVYDzP8fCogm1trpDps_D9ZqW' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 650 miles
Mayo Clinic
Phoenix,AZ

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03917381

Immunotherapy GEN1046 in Metastatic Triple Negative Breast Cancer

First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1046 in Subjects With Malignant Solid Tumors Scientific Title

Purpose

To find the best dose and study the effects (good and bad) of the experimental immunotherapy GEN1046.

Who is this for?

People with metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive GEN1046, by IV, every 3 weeks
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03917381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genmab.com/product-pipeline/products-in-development' target='_blank'>Drug Company Information Page: GEN1046</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2018/10/03/mbc-news-4/' target='_blank'>Metastatic Trial Talk: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>

NEAREST SITE: 650 miles
Mayo Clinic
Phoenix,AZ

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04301011

Immunotherapy TBio-6517 Alone or With Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2a, Multicenter, Open-label Trial of TBio-6517, an Oncolytic Vaccinia Virus, Administered by Intratumoral Injection, Alone and in Combination With Pembrolizumab, in Patients With Advanced Solid Tumors (RAPTOR) Scientific Title

Purpose

To determine the best dose and to study the effects (good and bad) of using the immunotherapy TBio-6517 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-) breast cancer. If your tumor is PD-L1 positive, you must have already received a PD-L1 or a PD-1 targeted therapy. Full eligibility criteria

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You will participate in either Phase 1 or Phase 2: Phase 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-6517, by injection directly into your tumor, 4 times (you may also receive boosters for up to 2 years)</li> </ul> Phase 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-6517, by injection directly into your tumor, 4 times (you may also receive boosters for up to 2 years)</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TBio-6517 is an immunotherapy that is injected directly into your tumor.</li> <li class="seamTextUnorderedListItem">TBio-6517 is an experimental drug, 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. It is approved for use in some cancers but its use in breast cancer is considered experimental.</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/NCT04301011' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://turnstonebio.com/#about-us' target='_blank'>Turnstone Biologics Drug Information Page: TBio-6517 (RIVAL-01)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Drug Information Page: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/keytruda-plus-chemo-better-than-chemo-alone-for-some' target='_blank'>Breastcancer.org: Keytruda Plus Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 650 miles
Mayo Clinic - Phoenix, AZ
Phoenix,AZ

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05001282

Basket Study of ELU001 in Tumors That Overexpress Folate Receptor Alpha (FRα)

Dose Escalation and Expansion Clinical Study to Evaluate the Safety and Efficacy of ELU001 in Subjects Who Have Advanced, Recurrent or Refractory FRα Overexpressing Tumors Scientific Title

Purpose

To study the effects (good and bad) of ELU001, a new type of targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose tumor overexpresses Folate Receptor Alpha (FRα). Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELU001</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ELU001 is a new type of targeted therapy called C'Dot drug conjugate (CDC). </li> <li class="seamTextUnorderedListItem">Drug conjugates deliver the drug directly to the tumor. </li> <li class="seamTextUnorderedListItem">Basket studies enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer whose tumors overexpress Folate Receptor Alpha (FRα).</li> <li class="seamTextUnorderedListItem">Targets or mutations: Folate Receptor Alpha (FRα)</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05001282' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2021/09/17/2299166/0/en/Elucida-Oncology-Announces-First-Patient-Dosed-in-Phase-1-2-Study-of-ELU001-in-Patients-with-Advanced-Recurrent-or-Refractory-Cancers-Overexpressing-Folate-Receptor-Alpha-FR%CE%B1.html' target='_blank'>Elucida Oncology Press Release: ELU001</a> </li></ul>

NEAREST SITE: 657 miles
Honor Health
Scottsdale,AZ

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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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CDK-002 (exoSTING™), by injection, directly into your tumor(s)</li> </ul> Please contact research site for treatment schedule Additional procedures <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>

NEAREST SITE: 657 miles
HonorHealth Research Institute
Scottsdale,AZ

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04787042

ST-067 for Advanced Triple Negative Breast Cancer

A Phase 1a Open-Label, Dose-Escalation, and a Phase 2 Study to Investigate the Safety, PK, PD, and Clinical Activity of ST-067 Administered Subcutaneously as Monotherapy in Patients With Relapsed or Refractory Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of ST-067, a targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ST-067, by IV</li> <li class="seamTextUnorderedListItem">2 biopsies</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ST-067 is a targeted therapy. It targets the IL-18 receptor.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced solid tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04787042' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 682 miles
Seattle Cancer Care Alliance
Seattle,WA

VISITS: 1 visit per month, ongoing

PHASE: II

NCT ID: NCT03941730

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

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

Purpose

To study the effects (good and bad) of estradiol in the subset of triple negative and ER-Low tumors that test positive for ER beta.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer whose tumor tests positive for estrogen receptor beta (ER beta). Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Estradiol, by mouth, 3 times a day</li> <li class="seamTextUnorderedListItem">2 biopsies (at the start of treatment and after 1 month)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Early studies suggest that estradiol--a type of estrogen--slows the growth of tumors that are ER-beta positive.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ER beta</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03941730' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Estrogen_receptor_beta' target='_blank'>Wikipedia: Estrogen receptor beta</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drugs.com/estradiol.html' target='_blank'>Drugs.com: Estradiol</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayo.edu/research/centers-programs/cancer-research/research-programs/womens-cancer-program/breast-cancer-spore/research-projects/therapeutic-targeting-estrogen-receptor-beta-triple-negative-breast-cancer' target='_blank'>Mayo Clinic: Therapeutic Targeting Estrogen receptor-beta in TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/30338035' target='_blank'>Journal Abstract: Estrogen receptor-beta is a potential target for TNBC</a> </li></ul>

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

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

PHASE: I

NCT ID: NCT02706392

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

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

Purpose

To assess the safety, effects (good and bad) and best dose of an experimental CAR-T immunotherapy that targets cancer cells that test positive for ROR1.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer that has not responded to other treatment options and that tests positive for ROR1. Full eligibility criteria

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

NEAREST SITE: 682 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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You will be assigned to 1 of 2 groups: Group 1 <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> Group 2 <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> Please contact the research site for the treatment schedule. A hospital stay will be required.
<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>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03739931

mRNA-2752 & Durvalumab for Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of mRNA-2752, a Lipid Nanoparticle Encapsulating mRNAs Encoding Human OX40L, IL-23, and IL-36Î³, 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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You will receive the following: <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>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04837677

PRT1419 For Advanced Triple Negative Breast Cancer

A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 in Patients With Advanced Solid Tumors Scientific Title

Purpose

To determine the best dose, safety, and effects (good and bad) of PRT1419, an experimental targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRT1419, by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRT1419 is an experimental targeted therapy called an MCL1 inhibitor.</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/NCT04837677' target='_blank'>ClinicalTrials.gov</a> </li></ul>

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

VISITS: 1 visit a week, ongoing

PHASE: I-II

NCT ID: NCT04561362

Immunotherapy and BT8009 for Metastatic Breast Cancer that Expresses Nectin-4

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies Scientific Title

Purpose

To study the safety, anti-cancer activity, and effects (good and bad) of giving the experimental therapy BT8009 alone or in combination with the PD-1 inhibitor nivolumab (Opdivo®).

Who is this for?

People with metastatic (stage IV) breast cancer that expresses Nectin-4 and who have no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009 is an experimental therapy that targets Nectin-4, a protein expressed in some breast cancer cells, and delivers a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nectin-4 is often expressed in triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Nectin-4</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04561362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-first-patient-dosed-phase-iii-0' target='_blank'>Press Release: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Drug Information Page: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Nectin' target='_blank'>Wikipedia: Nectin</a> </li></ul>

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

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

A Registry for People with Triple Negative or ER-Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

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

Purpose

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

Who is this for?

People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer. Full eligibility criteria

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This is a data collection (registry) study. You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>

NEAREST SITE: 1387 miles
University of Oklahoma Health Sciences Center
Oklahoma City,OK

VISITS: 1 visit every week (2 or 3 weeks on, 1 week off), ongoing

PHASE: I-II

NCT ID: NCT04345913

Chemotherapy and a PI3K Inhibitor for Advanced Triple Negative or ER-Low, HER2- Breast Cancer

A Phase I/II Trial Evaluating the Safety and Efficacy of Eribulin in Combination With Copanlisib in Patients With Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study and compare the safety, dose and anti-cancer activity of giving the chemotherapy eribulin (Halaven®) alone to giving it with the PI3K inhibitor copanlisib (Aliqopa®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER), HER2 negative (HER2-) breast cancer who have not already received more than five chemotherapies. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly (2 weeks on, 1 week off), ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, 2 or 3 times a month, ongoing </li> <li class="seamTextUnorderedListItem">Copanlisib (Aliqopa®), by IV, weekly (2 weeks on, 1 week off), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy approved for treating metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">Copanlisib (Aliqopa®) is a type of targeted therapy called a PI3K inhibitor. It is approved for use in lymphoma, 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.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04345913' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/eribulin.aspx' target='_blank'>Chemocare.com: Eribulin</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Copanlisib' target='_blank'>Wikipedia: Copanlisib</a> </li></ul>

NEAREST SITE: 1478 miles
Exelixis Clinical Site #2
Dallas,TX

VISITS: 1 visit a month, ongoing

PHASE: I

NCT ID: NCT04726332

An Experimental CDK 7 Inhibitor for Advanced Triple Negative or Hormone Positive Breast Cancer

A Dose Escalation and Expansion Study of the Safety and Pharmacokinetics of XL102 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To determine the safety, effects, and best dose of giving the experimental CDK 7 inhibitor XL102 alone or with fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stageIV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (ER+ and/or PR+) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XL102, by mouth, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XL102, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once every 2 weeks for 1.5 months, then every month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XL102 is a type of targeted therapy called a cyclin-dependent kinase (CDK) 7 inhibitor.</li> <li class="seamTextUnorderedListItem">XL102 blocks the protein CDK 7. Blocking this protein may slow or stop your cancer from growing. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is an anti-hormone therapy that is commonly used to treat postmenopausal women with HR+ tumors that have stopped responding to other anti-hormonal therapies.</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/NCT04726332' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.exelixis.com' target='_blank'>Exelixis Company Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/fulvestrant' target='_blank'>NCI Drug Dictionary: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/cdk46-inhibitors' target='_blank'>Breastcancer.org: What are CDK Inhibitors?</a> </li></ul>

NEAREST SITE: 1478 miles
Research Site
San Antonio,TX

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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What's being studied?
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You will be randomly assigned to 1 of 4 groups: Group 1 <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> Group 2 <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> Group 3 <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> Group 4 <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>

NEAREST SITE: 1479 miles
Mary Crowley Cancer Research Centers
Dallas,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT03150810

BGB-290 with Temozolomide for Advanced Breast Cancer

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To investigate the safety and effects (good and bad) of using an oral chemotherapy along with a new targeted drug to treat advanced breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have not already received a PARP inhibitor. If you have triple negative (ER-, PR-, HER2-) breast cancer, you must have received less than three prior therapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BGB-290, by mouth</li> <li class="seamTextUnorderedListItem">Temolozomide, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two drugs being used in this study are temozolomide (Temodar) and BGB-290. </li> <li class="seamTextUnorderedListItem">Temodar is used to treat brain cancer. </li> <li class="seamTextUnorderedListItem">BGB-290 is a type of targeted therapy called a PARP inhibitor.</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/NCT03150810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a601250.html' target='_blank'>NIH MedlinePlus: Temozolomide</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.beigene.com/pipeline/clinical-candidates/bgb-290/' target='_blank'>Drug Company Information Page: BGB-290</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/drugs/temozolomide' target='_blank'>Cancer Research UK: Temozolomide</a> </li></ul>

NEAREST SITE: 1481 miles
Next Oncology ( Site 0001)
San Antonio,TX

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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What's involved?
What's being studied?
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You will receive the following: <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>

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

VISITS: 1 visit every month, ongoing

PHASE: I

NCT ID: NCT03821935

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

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

Purpose

To investigate the safety, best dose and effects (good and bad) of ABBV-151 when it used with or without ABBV-181.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has been treated with at least one systemic therapy. Full eligibility criteria

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You will be assigned to 1 of the 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151, by IV, once a month, ongoing</li> <li class="seamTextUnorderedListItem">ABBV-181, by IV, once a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABBV-151 is a targeted therapy that blocks a protein called GARP- TGF-β1. </li> <li class="seamTextUnorderedListItem">ABBV-181 is an experimental PD-1 inhibitor. This type of immunotherapy, called a checkpoint inhibitor, gets the immune system to see and go after cancer cells.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03821935' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abbvie.com/our-science/pipeline/abbv-151.html' target='_blank'>Drug company information page: ABBV-151</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/abbv-181/' target='_blank'>Immuno-oncology news: ABBV-181</a> </li></ul>

NEAREST SITE: 1481 miles
NEXT Oncology
San Antonio,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT04441099

Targeted Therapy NBE-002 for Advanced Triple Negative Breast Cancer

A First-in-Human, Phase 1/2 Study of NBE-002, an Anti-ROR1 Antibody Drug Conjugate, in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, and anti-cancer activity of the experimental targeted therapy NBE-002.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than three therapies for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBE-002, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NBE-002 is a type of targeted therapy called an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Antibody-drug conjugates are cancer therapies that combine an antibody that targets cancer cells with a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the drug does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">The antibody in NBE-002 targets ROR1 proteins. </li> <li class="seamTextUnorderedListItem">NBE-002 delivers an anthracycline-based chemotherapy. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04441099' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancerres.aacrjournals.org/content/79/13_Supplement/LB-197' target='_blank'>AACR Abstract: NBE-002</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Antibody-drug_conjugate' target='_blank'>Wikipedia: Antibody-Drug Conjugate</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>MetastaticTrialTalk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li></ul>

NEAREST SITE: 1481 miles
Mays Cancer Center, UT Health San Antonio
San Antonio,TX

VISITS: 2 visits every 3 weeks, ongoing

PHASE: NA

NCT ID: NCT03995706

Antibody Drug-Conjugate Sacituzumab Govitecan for Breast Cancer That Has Spread to the Brain

A Phase 0, Investigator Initiated Study to Determine the Bioavailability of Sacituzumab Govitecan in Breast Brain Metastasis and Glioblastoma Scientific Title

Purpose

To study if sacituzumab govitecan -- an antibody-drug conjugate -- crosses the blood-brain barrier to treat brain mets.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread to the brain and who are scheduled to have surgery to remove their brain tumors. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, 1 day before surgery, then 2 times every 3 weeks, 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></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03995706' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Sacituzumab_govitecan' target='_blank'>Wikipedia: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan-Hziy)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/pages/Fall2015/Advances-Treating-Brain-Metastases.aspx' target='_blank'>Cancer Today: Breaking the Blood-Brain Barrier</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>MetastaticTrialTalk: Getting to the Target, Antibody Drug Conjugates in Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/NEJMoa1814213' target='_blank'>The New England Journal of Medicine: Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas,TX

VISITS: Number of visits unavailable, ongoing

PHASE: NA

NCT ID: NCT04265872

Bortezomib, Pembrolizumab and Cisplatin for Women with Metastatic Triple Negative or ER-Low Breast Cancer

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

Purpose

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

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) breast cancer who have not received more than three chemotherapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®), by IV</li> <li class="seamTextUnorderedListItem">followed by, pembrolizumab (Keytruda®) and cisplatin (Platinol®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Bortezomib (Velcade®) is a type of targeted therapy called a protease inhibitor. It is approved for use in some other cancers but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to go after cancer cells. It is approved for use in some cancers but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy commonly used for metastatic triple negative breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04265872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Bortezomib' target='_blank'>Wikipedia: Bortezomib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.velcade.com/about-velcade/faq' target='_blank'>Takeda Pharmaceutical Company Drug Information Page: Velcade® (Bortezomib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.medpagetoday.com/meetingcoverage/asco/86804' target='_blank'>MedPage Today: Pembrolizumab May Help in Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://oncobites.blog/2020/02/07/cisplatin-a-journey-to-a-solution-for-triple-negative-breast-cancer/' target='_blank'>OncoBites Blog: Cisplatin--A Journey to a Solution for Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 1482 miles
Baylor University Medical Center
Dallas,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04032080

LY3023414 Followed by Prexasertib in Metastatic Triple Negative Breast Cancer

Pilot Clinical Trial Of Treatment With Oral LY3023414 To Inhibit Homologous Recombination (HR) Followed By Prexasertib In Patients With Chemotherapy-Pretreated Metastatic Triple Negative Breast Cancer (ExIST) Scientific Title

Purpose

To look at the safety and effects (good and bad) of treating patients with the investigational targeted therapy LY3023414 followed by the investigational targeted therapy prexasertib.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer who have not had more than 3 chemotherapy regimens. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3023414, by mouth, twice a day, until disease progression </li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy</li> <li class="seamTextUnorderedListItem">Prexasertib, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY3023414 is a type of targeted therapy called a PI3K/mTOR inhibitor. </li> <li class="seamTextUnorderedListItem">Prexasertib is a targeted therapy that blocks checkpoint kinase1 (chk1), which plays a role in chemotherapy resistance.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04032080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/prexasertib' target='_blank'>NCI Drug Dictionary: Prexasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-mtor-inhibitor-ly3023414' target='_blank'>NCI Drug Dictionary: LY3023414</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.1064' target='_blank'>Journal of Clinical Oncology: Safety and tolerability of LY3023414 in combination with fulvestrant in treatment refractory advanced breast cancer</a> </li></ul>

NEAREST SITE: 1556 miles
Highlands Oncology
Springdale,AR

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04577963

Targeted Therapy and Immunotherapy for Advanced Triple Negative Breast Cancer

An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of giving a VEGFR inhibitor along with immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer who have not received more than three chemotherapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fruquintinib, by mouth, ongoing</li> <li class="seamTextUnorderedListItem">Tislelizumab, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fruquintinib is a tyrosine kinase inhibitor designed to block the protein VEGFR (vascular endothelial growth factor receptor). Tumors use VEGFR to grow new blood vessels. Research suggests VEGFR inhibitors may slow or stop cancer cell growth.</li> <li class="seamTextUnorderedListItem">Tislelizumab is an experimental type of immunotherapy called a PD-1 inhibitor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04577963' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.beigene.com/en-us/science-and-product-portfolio/pipeline/tislelizumab' target='_blank'>BeiGene Drug Information Page: Tislelizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fruquintinib' target='_blank'>NCI Drug Dictionary: Fruquintinib</a> </li></ul>

NEAREST SITE: 1591 miles
Cox Medical Center
Springfield,MO

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03671044

Comparing an Experimental form of Docetaxel to Standard Docetaxel in Women with Advanced Triple Negative Breast Cancer

A Global, Multicenter, Three Arms, Open-label Randomized Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere® (Docetaxel Injection Concentrate) in Triple-negative Breast Cancer Patients With Locally Advanced or Metastatic Breast Cancer After Failure to Prior Chemotherapy Scientific Title

Purpose

To compare the safety and anti-cancer activity of Nanosomal Docetaxel Lipid Suspension (NDLS) to docetaxel (Taxotere®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV), triple negative (ER-, PR-, HER2-) breast cancer who have received no more than one chemotherapy for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Nanosomal Docetaxel Lipid Suspension (NDLS), by IV, every 3 weeks, ongoing</li> </ul> Group 2: Standard <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®) is a chemotherapy commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Nanosomal Docetaxel Lipid Suspension (NDLS) is an experimental form of docetaxel. </li> <li class="seamTextUnorderedListItem">Research suggests that NDLS is safer than the standard form of docetaxel.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03671044' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancernow.org/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/docetaxel-taxotere' target='_blank'>Breast Cancer Now: Docetaxel</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/nanosomal-docetaxel-lipid-suspension' target='_blank'>NCI Drug Dictionary: Nanosomal Docetaxel Lipid Suspension</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/28255844/' target='_blank'>Journal Abstract: Nanosomal Docetaxel Lipid Suspension</a> </li></ul>

NEAREST SITE: 1621 miles
MD Anderson in The Woodlands
Conroe,TX

VISITS: 1 visit a week, ongoing

PHASE: I

NCT ID: NCT02419495

Targeted Therapy Selinexor with Chemotherapy or Immunotherapy for Metastatic Triple Negative Breast Cancer

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies Scientific Title

Purpose

To study the safety, side effects, and best dose of giving selinexor (XPOVIO®) along with eribulin (Halaven®).

Who is this for?

People with metastatic (stage IV) triple-negative (ER-, PR-, HER2) breast cancer with no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Selinexor (XPOVIO®), by mouth, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, 2 or 3 times a month, for 3 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Selinexor (XPOVIO®) is a type of targeted therapy called an XP01 inhibitor. It is approved for use in myeloma, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">The XP01 protein helps move tumor suppressors out of the cancer cell's nucleus, thus allowing cancer cells to grow. </li> <li class="seamTextUnorderedListItem">Blocking XPO1 means that tumor suppressors stay in the cancer cell's nucleus, which may help kill the cancer cell. </li> <li class="seamTextUnorderedListItem">The chemotherapy eribulin (Halaven®) is approved for treating metastatic breast cancer.</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/NCT02419495' 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://pubmed.ncbi.nlm.nih.gov/30996012/' target='_blank'>Journal Abstract: Selinexor (KPT-330) for Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://myelomaresearchnews.com/inhibitors-of-nuclear-export/' target='_blank'>Myeloma Research News: Selinexor</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT02926690

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

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

Purpose

To determine the safety and effects (good and bad) of using the experimental targeted therapy OTS167PO.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast (ER-, PR-, HER2-) or ER-Low (1%-10%) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OTS167PO </li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The targeted therapy used in this trial is OTS167PO. It is a MELK inhibitor. </li> <li class="seamTextUnorderedListItem">It is an experimental therapy. This means it is only available in clinical trials. </li> <li class="seamTextUnorderedListItem">Targets or mutations: MELK</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02926690' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncotherapy.co.jp/en/research-development/drug-discovery-research/melk-inhibitor/' target='_blank'>Drug Company Information Page: OTS167</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/melk-inhibitor-ots167' target='_blank'>NCI Drug Dictionary: OTS167</a> </li></ul>

NEAREST SITE: 1643 miles
Baylor College of Medicine
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04123704

An Experimental Targeted Therapy for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Sitravatinib in Metastatic, Pre-treated, Triple Negative Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity and side effects of the experimental targeted therapy sitravatinib (MGCD516).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. You must have received at least one chemotherapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sitravatinib (MGCD516), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sitravatinib (MGCD516) is an experimental kinase inhibitor that blocks the proteins YRO3, AXL, MERTK, VEGFR2, and KIT.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04123704' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mirati.com/science/programs/sitravatinib/' target='_blank'>Mirati Therapeutics Drug Information Page: Sitravatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Triple-Negative MBC</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04706962

Investigational Therapy TH1902 for Metastatic Triple Negative Breast Cancer

A Phase 1, Open-Label, Dose Escalation Study of TH1902 in Patients With Advanced Solid Tumors and Expansion in Patients With Triple Negative Breast Cancer (TNBC), Gynecological Cancer, Colorectal Cancer, and Pancreatic Cancer Scientific Title

Purpose

To study the safety, dose, side effects, and anti-cancer activity of the investigational therapy TH1902.

Who is this for?

People with metastatic (stage IV) triple-negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TH1902, by IV, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TH1902 is a type of therapy called a peptide drug-conjugate (PDC).</li> <li class="seamTextUnorderedListItem">A peptide drug-conjugate combines a peptide that targets cancer cells with a therapy that can kill cancer cells. </li> <li class="seamTextUnorderedListItem">The anti-cancer therapy in TH1902 is the commonly used chemotherapy docetaxel.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04706962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.theratech.com/products/th-1902/' target='_blank'>Thera Technologies Drug Information Page: TH1902</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/fda-grants-fast-track-designation-to-th1902-in-sort1-recurrent-advanced-solid-tumors' target='_blank'>Targeted Oncology: FDA Grants Fast Track Designation to TH1902</a> </li></ul>

NEAREST SITE: 1643 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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You will receive: <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>

NEAREST SITE: 1643 miles
Kymab investigator site 1101
Houston,TX

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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You will be assigned to 1 of 2 groups: Group 1: Monotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044</li> </ul> Group 2: Combination Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KY1044</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV</li> </ul> Please contact research site for treatment schedule
<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>

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

VISITS: Weekly visits

PHASE: I

NCT ID: NCT04429542

BCA101 for Metastatic Triple Negative Breast Cancer That Tests Positive for EGFR

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFÎ² Fusion Protein BCA101 Alone and in Combination With Pembrolizumab in Patients With EGFR-Driven Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity, and effects (good and bad) of the targeted therapy BCA101.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that tests positive for EGFR amplification and who have no other treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BCA101, by IV, once a week, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BCA101 targets the EGFR and TGFβ pathways. </li> <li class="seamTextUnorderedListItem">It is an experimental targeted therapy, this means it is only available in clinical trials.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of metastatic cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: EGFR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04429542' 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://europepmc.org/article/med/27648353' target='_blank'>Journal Article Abstract: A Perspective on Anti-EGFR Therapies Targeting Triple Negative Breast Cancer.</a> </li></ul>

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03990896

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) BRCA1/2 Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial Scientific Title

Purpose

To study the anti-cancer activity of the PARP inhibitor Talazoparib (Talzenna®) in breast cancer tumors that test positive for a tumor (not inherited) BRCA 1 or BRCA 2 mutation.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Your tumor must test positive for a BRCA 1 or a BRCA 2 tumor (not inherited) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called germline when they are inherited. </li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called somatic when they are not inherited.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA 1 (tumor), BRCA 2 (tumor)</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03990896' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation' target='_blank'>NCI Drug Dictionary: Somatic Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109817433' target='_blank'>Pfizer Oncology: Talzenna®</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2016/07/how-do-parp-inhibitors-work-in-cancer/' target='_blank'>Dana-Farber Cancer Institue: How Do PARP Inhibitors Work In Cancer? (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2017/vol-18-no-13/blurring-the-lines-between-germline-and-somatic-mutations-in-cancer' target='_blank'>OncLive: Blurring the Lines Between Germline and Somatic Mutations in Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41416-018-0127-5' target='_blank'>Journal Article: BRCA1/2 Testing: Therapeutic Implications for Breast Cancer Management</a> </li></ul>

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

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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You will receive the following: <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>

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

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04234113

SO-C101 (Immunotherapy) Alone or With Pembrolizumab In Advanced Triple Negative Breast Cancer

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, best dose, anti-tumor activity and effects (good and bad) of the experimental immunotherapy drug SO-C101 (RLI-15) when it is given alone or in combination with pembrolizumab (Keytruda®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no standard treatment options. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SO-C101</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SO-C101</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">SO-C101 (RLI-15) is a new type of immunotherapy that works by getting immune cells called natural killer cells to kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental. </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/NCT04234113' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sotio.com/pipeline/so-c101' target='_blank'>Drug Company Information Page: SO-C101 (RLI-15)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAiA1rPyBRAREiwA1UIy8AIFO2xkZ72nv59oRzgEL2_j5xbdlfT_f9w1NuFPTrkeUqYvN9yqxxoCBOYQA' target='_blank'>Merk Oncology Drug Information: Keytruda® (Pembrolizumab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerhealth.com/article/immunotherapies-show-mixed-results-triplenegative-breast-cancer' target='_blank'>Cancer Health: Immunotherapies Show Mixed Results for Triple-Negative Breast Cancer</a> </li></ul>

NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center MD Anderson PSC
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03549000

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

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

Purpose

To compare the safety and effects (good and bad) of NZV930 alone or in combination with PDR001 and/or NIR178.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options. Full eligibility criteria

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You will be assigned to 1 of 4 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV </li> <li class="seamTextUnorderedListItem">PDR001, by IV</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV</li> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930, by IV</li> <li class="seamTextUnorderedListItem">PDR001, by IV</li> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> </ul> Please contact research site for treatment schedule Additional procedures: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 biopsies (a new tumor biopsy at screening and during treatment)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NZV930 is an investigational targeted therapy that blocks the CD73 protein. Blocking this protein allows T cells and other immune cells to attack the tumor. </li> <li class="seamTextUnorderedListItem">PDR001 is an investigational immunotherapy. It is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">NIR178 is an investigational immunotherapy. It is an immune checkpoint inhibitor that gets the immune system to attack cancer cells by blocking the adenosine A2A receptor (A2AR).</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03549000' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.surfaceoncology.com/our-science/srf373-nzv930-cd73-antibody/' target='_blank'>Sponsor site: AZV930</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/793151' target='_blank'>NCI Drug Dictionary: NIR178</a> </li></ul>

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT02411656

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

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

Purpose

To look at the safety and effects (good and bad) of using pembrolizumab (Keytruda®).

Who is this for?

People with recurrent or metastatic (stage IV) HER2 negative breast cancer that is also inflammatory or hormone negative (ER- and PR-) or hormone low expressing (ER and/or PR 1%-10%). Full eligibility criteria

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

NEAREST SITE: 1655 miles
University of Iowa Hospital and Clinics
Iowa City,IA

VISITS: Weekly visits, ongoing

PHASE: I-II

NCT ID: NCT03911973

Gedatolisib and Talazoparib in Advanced HER2 Negative, Inherited BRCA1/2+ or Triple Negative Breast Cancer

Phase 2 Trial With Safety Run-In of Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers Big Ten Cancer Research Consortium BTCRC-BRE18-337 Scientific Title

Purpose

To determine the safety, best dose, and effects (good and bad) of gedatolisib when it is used in combination with talazoparib (Talzenna®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose cancer is triple negative (ER-, PR-, HER2-) or who have an inherited BRCA1 or BRCA2 mutation and HER2 negative (HER2-) breast cancer. Full eligibility criteria

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You will receive: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by IV, once a week </li> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, once a day</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy that works by blocking two proteins, called PI3K and mTOR, that help tumors grow. </li> <li class="seamTextUnorderedListItem">Talzenna is a type of targeted therapy called a PARP inhibitor. It is approved to treat HER2 negative advanced or metastatic breast cancer in people with an inherited BRCA mutation.</li> <li class="seamTextUnorderedListItem">Targets or mutations: inherited BRCA 1 and BRCA 2 mutations.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03911973' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-approves-talazoparib-for-brcamutated-her2negative-breast-cancer' target='_blank'>OncLive: FDA Approves Talazoparib for BRCA-Mutated, HER2- Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/files/news/asco/Pfizer_IO_GetaPI3KFactSheet.pdf' target='_blank'>Pfizer Oncology Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 1678 miles
The University of Wisconsin
Madison,WI

VISITS: At least 1 visit per month

PHASE: II

NCT ID: NCT03207867

Combination Immunotherapies for Advanced Triple Negative Breast Cancer

A Phase 2, Multi-center, Open Label Study of NIR178 in Combination With PDR001 in Patients With Selected Advanced Solid Tumors and Non-Hodgkin Lymphoma Scientific Title

Purpose

To study the safety and effects (good and bad) of using two different types of immunotherapy drugs at the same time to treat advanced triple negative breast cancer.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIR178, by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">PDR001, by IV, monthly, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The two experimental immunotherapies being used in this study are NIR178 and PRD001.</li> <li class="seamTextUnorderedListItem">NIR178 is an adenosine receptor antagonist. It blocks adenosine, which is found in the microenvironment that surrounds the tumor. </li> <li class="seamTextUnorderedListItem">PDR001 is a type of immunotherapy called a PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling patients with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03207867' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/understanding-immunotherapy' target='_blank'>Cancer.net: Understanding Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/pdr001/' target='_blank'>Immuno-Oncology News: PDR001</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.novartis.com/news/media-releases/novartis-continues-grow-immuno-oncology-pipeline-through-collaboration-and' target='_blank'>Novartis: NIR178</a> </li></ul>

NEAREST SITE: 1735 miles
Washington University in St. Louis
Saint Louis,MO

VISITS: 1 visit a week, ongoing

PHASE: II

NCT ID: NCT02755272

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

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

Purpose

To study the anti-cancer activity of giving the PD-1 inhibitor pembrolizumab (Keytruda®) immunotherapy in combination with chemotherapy.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10%) breast cancer. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and gemcitabine (Gemzar®) by IV, once a week, 2 weeks on 1 week off</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and gemcitabine (Gemzar®) by IV, once a week, 2 weeks on 1 week off</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling women with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking PD-1.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02755272' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/?src=google&med=cpc&camp=Keytruda+Pan+Tumor_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=Brand+Keyword_General&kw=keytruda&utm_kxconfid=sq7irm3mh&gclid=CjwKCAjwy7vlBRACEiwAZvdx9jIPFQgWidLA-C5wT1MzjtITa1lJzO4axMQhgd1rro0RP5g40-abvxoCQlYQA' target='_blank'>Merck Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 1814 miles
The West Clinic, P.C. ( Site 0021)
Germantown,TN

VISITS: 1 visit every week, ongoing

PHASE: I

NCT ID: NCT03396445

Two Immunotherapies and Chemotherapy for Advanced Triple Negative Breast Cancer

A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving the experimental immunotherapy MK-5890 with the immunotherapy pembrolizumab (Keytruda®) and the chemotherapy nab-paclitaxel (Abraxane®).

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MK-5890, by IV, every 1.5 months, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 1.5 months, 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">MK-5890 is an experimental immunotherapy that may help stimulate the immune system to go after cancer cells. It is a CD27 antigen stimulant.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, it gets the immune system to go after cancer cells. It is approved to treat many types of cancers, including some types of breast cancer, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a chemotherapy routinely used to treat advanced breast cancer.</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/NCT03396445' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/in-advanced-solid-tumors-mk5890-shows-promising-safety-results-as-monotherapy-or-in-combination-with-pembrolizumab' target='_blank'>Targeted Oncology: In Advanced Solid Tumors, MK-5890 Shows Promising Safety Results as Monotherapy or in Combination with Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com/triple-negative-breast-cancer/?src=google&med=cpc&camp=Keytruda+TNBC_Brand_BRND_NA_ENGM_EXCT_TEXT_NA&adgrp=TNBC&kw=keytruda+tnbc&utm_kxconfid=ttznk4gb9&gclid=Cj0KCQiA1pyCBhCtARIsAHaY_5dvAZFxDyc_NLdQ8BmU45jQz7LkNGbiHjqmyNrwHEZhlney' target='_blank'>Merck Oncology Information Page: Keytruda® (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></ul>

NEAREST SITE: 1832 miles
Froedtert and the Medical College of Wisconsin
Milwaukee,WI

VISITS: 1 visit a week, ongoing

PHASE: II

NCT ID: NCT02788981

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

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

Purpose

To determine the safety and effects (good and bad) of using chemotherapy in combination with the anti-progesterone therapy mifepristone.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- HER2-) or ER-Low (1%-10% ER) breast cancer that tests positive for glucocorticoid receptors. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Mifepristone, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on, 1 week off)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly (3 weeks on, 1 week off)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The chemotherapy being used in this study is nab-paclitaxel (Abraxane®). It is approved to treat advanced breast cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: glucocorticoid receptors</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02788981' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3860283/' target='_blank'>Clinical Cancer Research: Glucocorticoid receptor antagonism for TNBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abraxanepro.com' target='_blank'>Drug Company Information Page: Abraxane</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Mifepristone' target='_blank'>Wikipedia: Mifepristone</a> </li></ul>

NEAREST SITE: 1857 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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You will be randomly assigned to 1 of 2 groups: Group 1 <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> Group 2 <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>

NEAREST SITE: 1857 miles
University of Chicago Medical Center
Chicago,IL

VISITS: 2 visits every 3 weeks

PHASE: II

NCT ID: NCT04448886

Sacituzumab Govitecan With or Without Pembrolizumab for Advanced HR+, HER2- Breast Cancer that is PD-L1+

Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC) Scientific Title

Purpose

To study the safety and anti-cancer activity of giving sacituzumab govitecan (Trodelvy) alone or with pembrolizumab (Keytruda®).

Who is this for?

People with locally advanced (some stage III) or metastatic (stage IV), hormone positive (ER+ and/or PR+), HER2 negative (HER2-), PD-L1 positive breast cancer who have not received more than one chemotherapy for metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, 2 out of every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, 2 out of every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy drug directly to these cells.</li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. 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 (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PD-L1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04448886' target='_blank'>ClinicalTrials.gov</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.onclive.com/view/fda-approvals-sought-for-2-pembrolizumab-indications-in-tnbc' target='_blank'>OncLive: FDA Approvals Sought for 2 Pembrolizumab Indications in TNBC</a> </li></ul>

NEAREST SITE: 1946 miles
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis,IN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT04134884

ASTX727 and Talazoparib in Advanced HER2 Negative Breast Cancer

A Phase I Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/ Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of using the PARP inhibitor Talazoparib (Talzenna®) along with the targeted therapy ASTX727.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have already received chemotherapy or a CDK 4/6 inhibitor with hormone therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">ASTX727, by mouth, first 5 days of every cycle (28 days), ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of drug called a PARP inhibitor. It works by preventing the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is approved to treat advanced or metastatic HER2 negative (HER2-) breast cancer in people with an inherited BRCA 1 or BRCA 2 mutation.</li> <li class="seamTextUnorderedListItem">ASTX727 is an investigational targeted therapy that is only available in clinical trials.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04134884' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_+pfizer++talazoparib&skwid=43700051780428716' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/expertconnections/parp-inhibition-brca-mutated-breast-cancer/benefit-of-parp-inhibitors-in-brca-positive-breast-cancer' target='_blank'>Cure Today: Benefit of PARP Inhibitors in BRCA+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cda-inhibitor-e7727-decitabine-combination-agent-astx727' target='_blank'>NCI Drug Dictionary: ASTX727 (CDA Inhibitor E7727)</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/astx727-oral-dnmt-inhibitor-hematological-malignancies/' target='_blank'>Drug Company Information Page: ASTX727 (Cedazuridine and Decitabine)</a> </li></ul>

NEAREST SITE: 1959 miles
Sarah Cannon Research Institute Sarah Cannon Research
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03742349

Four Immunotherapy Combinations in Advanced Triple Negative Breast Cancer

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

Purpose

To study the safety, best dose and effects (good and bad) of spartalizumab and LAG525 when they are used in combination with NIR178, capmatinib, MCS110, or canakinumab.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not received more than two prior lines of chemotherapy, including neoadjuvant or adjuvant chemotherapy; and have had a taxane-based chemotherapy as neoadjuvant or metastatic treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab (PDR001), by IV</li> <li class="seamTextUnorderedListItem">LAG525, by IV</li> </ul> with 1 of the following 4 drugs: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NIR178, by mouth</li> <li class="seamTextUnorderedListItem">Capmatinib (INC280), by mouth</li> <li class="seamTextUnorderedListItem">MCS110 (INC280), by IV</li> <li class="seamTextUnorderedListItem">Canakinumab (ACZ885), by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Spartalizumab is an investigational PD-1 immune checkpoint inhibitor. </li> <li class="seamTextUnorderedListItem">LAG525 is an investigational immune checkpoint inhibitor that targets LAG-3. </li> <li class="seamTextUnorderedListItem">NIR178 is an investigational immunotherapy. </li> <li class="seamTextUnorderedListItem">Capmatinib is a targeted therapy that blocks c-Met, which plays a role in cancer cell growth.</li> <li class="seamTextUnorderedListItem">MCS110 is an investigational immunotherapy that targets M-CSF. </li> <li class="seamTextUnorderedListItem">Canakinumab is an investigational monoclonal antibody that targets human interleukin-1 beta (IL-1b), which plays a role in inflammation.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742349' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/spartalizumab' target='_blank'>NCI Drug Dictionary: Spartalizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-lag-3-monoclonal-antibody-lag525' target='_blank'>NCI Drug Dictionary: LAG525</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/capmatinib' target='_blank'>NCI Drug Dictionary: Capmatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-m-csf-monoclonal-antibody-mcs110' target='_blank'>NCI Drug Dictionary: MCS110</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795723' target='_blank'>NCI Drug Dictionary: Canakinumab</a> </li></ul>

100

NEAREST SITE: 1959 miles
Sarah Cannon Research Institute Drug Ship - 3
Nashville,TN

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03891953

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

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

Purpose

To compare the safety and effects (good and bad) of DKY709 alone and in combination with PDR001.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not been treated with a PD-1 or PD-L1 checkpoint inhibitor. Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">DKY709</li> <li class="seamTextUnorderedListItem">PDR001 (Spartalizumab)</li> </ul> Please contact research site for treatment schedule
<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>

101

NEAREST SITE: 1985 miles
Baptist Health Clinical Research
Elizabethtown,KY

VISITS: At least 2 visits over 6-8 weeks

PHASE: NA

NCT ID: NCT05037825

How the Gut Microbiome May Affect Immunotherapy in Stage I-IV Triple Negative Breast Cancer

The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors Scientific Title

Purpose

To study the gut microbiome to see if it can determine if immunotherapy will be effective.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative breast cancer (ER-, PR- and HER2-) who are about to begin treatment with a checkpoint inhibitor (immunotherapy). You must speak English or Spanish. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 blood tests over 6-8 weeks</li> <li class="seamTextUnorderedListItem">2 stool samples over 6-8 weeks</li> <li class="seamTextUnorderedListItem">Questionairres (in English or Spanish)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The microbiome may help determine if immunotherapy will be effective. </li> <li class="seamTextUnorderedListItem">By studying the microbiome, researchers may also be able to determine if changing the microbiome through diet, exercise, prebiotics, probiotics, or microbially-derived metabolites, can help the immune system fight cancer.</li> <li class="seamTextUnorderedListItem">Immunotherapies are drugs that trigger the immune system to see, go after, and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) and atezolizumab (Tecentriq®) are 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/NCT05037825' target='_blank'>ClinicalTrials.gov</a> </li></ul>

102

NEAREST SITE: 2088 miles
Karmanos Cancer Institute
Detroit,MI

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT02632448

LY2880070 in Advanced Triple Negative Breast Cancer

A Phase 1b/2a Two-Part Open-Label Multicenter Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer Scientific Title

Purpose

To study the safety and effects (good and bad) of an investigational drug called LY2880070.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY2880070, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY2880070, by mouth</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LY2880070 inhibits CHK1, which may improve how a tumor responds to a chemotherapy drug. </li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) is a chemotherapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">This study will also enroll 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/NCT02632448' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/gemzar' target='_blank'>Breastcancer.org: Gemzar</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancercare.org.uk/information-support/facing-breast-cancer/going-through-treatment-breast-cancer/chemotherapy/gemcitabine-gemzar#who' target='_blank'>BreastCancerNow.org: Gemzar</a> </li></ul>

103

NEAREST SITE: 2107 miles
The Ohio State University Stefanie Spielman Comprehensive Breast Center
Columbus,OH

VISITS: 5 visits per month, ongoing

PHASE: II

NCT ID: NCT04445844

Immunotherapies MGA012 and Pelareorep for Advanced Triple Negative Breast Cancer

IRENE Study: Phase 2 Study of INCMGA00012 and the Oncolytic Virus Pelareorep in Metastatic Triple Negative Breast Cancer Scientific Title

Purpose

To study the safety and anti-cancer activity of combining the experimental checkpoint inhibitor MGA012 with the oncolytic virus pelareorep.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received one to three prior therapies for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pelareorep, by IV, 2 days a week, every other week, ongoing</li> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab), by IV, once a month, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MGA012 (Retifanlimab) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking the protein PD-1.</li> <li class="seamTextUnorderedListItem">Pelareorep is an oncolytic virus--a virus that targets and kills cancer cells. It may directly kill cancer cells and stimulate your immune system to 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/NCT04445844' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.macrogenics.com/mga012-pd-1/' target='_blank'>Macrogenics Drug Information Page: Retifanlimab (MGA012)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-pd-1-monoclonal-antibody-mga012' target='_blank'>NCI Drug Dictionary: MGA012</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Pelareorep' target='_blank'>Wikipedia: Pelareorep</a> </li><li class='seamTextUnorderedListItem'><a href='https://breastcancer-news.com/2020/09/14/first-patient-dosed-irene-clinical-trial-testing-immunotherapy-oncolytic-virus-combo-for-tnbc/' target='_blank'>Breast Cancer News: First Patient Dosed in IRENE Trial Testing Immunotherapy-Oncolytic Virus Combo</a> </li><li class='seamTextUnorderedListItem'><a href='https://graspcancer.org/wp-content/uploads/2021/12/Group6E_2.pdf' target='_blank'>GRASP: IRENE Study research poster</a> </li></ul>

104

NEAREST SITE: 2139 miles
Winship Cancer Institute of Emory University
Atlanta,GA

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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You will receive the following: <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>

105

NEAREST SITE: 2265 miles
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh,PA

VISITS: 1 visit every month, ongoing

PHASE: I

NCT ID: NCT04514484

Targeted Therapy and Immunotherapy for Advanced Triple Negative Breast Cancer and HIV

Pilot Trial of Nivolumab Plus Cabozantinib for Advanced Solid Tumors in Patients With HIV Infection Scientific Title

Purpose

To study the safety, side effects, and anti-cancer activity of giving the targeted therapy cabozantinib (Cabometyx®) with the immunotherapy nivolumab (Opdivo®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who are receiving treatment for HIV. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, once a month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cabozantinib ( Cabometyx®) is a targeted therapy that blocks some of molecules (c-Met, VEGFR2, AXL and RET.) that cells need to grow. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a PD-1 inhibitor. By blocking PD-1, it helps the immune system see and kill cancer cells. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">HIV (human immunodeficiency virus) is a virus that attacks the body's immune system. HIV can affect the outcome of cancer treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04514484' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?id=NCI-2020-05956&r=1' target='_blank'>National Cancer Institute: Study Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/cabozantinib-s-malate' target='_blank'>NCI Drug Dictionary: Cabozantinib (Cabometyx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cabometyx.com/?gclid=Cj0KCQiAyJOBBhDCARIsAJG2h5csfcndMVfIxEH_77I0NfOF7sZ2p4uEvWyys27Gaj9s6e7c7nXm3rMaArkeEALw_wcB' target='_blank'>Exelixis Drug Information Page: Cabometyx® (Cabozantinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertodaymag.org/Pages/cancer-talk/HIV-Can-Worsen-Cancer-Treatment-Outcomes.aspx' target='_blank'>Cancer Today: HIV Can Worsen Cancer Treatment Outcomes</a> </li></ul>

106

NEAREST SITE: 2354 miles
McKnight Brain Institute of the University of Florida
Gainesville,FL

VISITS: Surgery followed by 1 visit every 3 weeks for 2 years

PHASE: I

NCT ID: NCT04187872

Laser Thermotherapy and Pembrolizumab for Triple Negative Breast Cancer that has Spread to the Brain

Recurrent Brain Metastasis Immune Effects and RespOnse to Laser Interstitial ThermotHerapy (LITT) and Pembrolizumab in Combination (TORCH) Scientific Title

Purpose

To study the immune effect of Laser Interstitial Thermotherapy (LITT), a type of surgery, given with pembrolizumab (Keytruda®).

Who is this for?

People with triple negative (ER-, PR-, HER2-) metastatic (stage IV) breast cancer that has spread to the brain (brain metastases). Your brain mets must have been treated with stereotactic radiosurgery and must test positive for PD-L1. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain biopsy and laser interstitial thermotherapy (LITT)</li> <li class="seamTextUnorderedListItem">Pembrolizumab, by IV, every 3 weeks for up to 2 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Laser Interstitial Thermotherapy (LITT) is a minimally-invasive surgical technique to treat primary and metastatic brain tumors that can be hard to reach with conventional surgery. </li> <li class="seamTextUnorderedListItem">LITT is done by implanting a laser catheter into the tumor and heating it to temperatures high enough to kill the tumor.</li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy called a PD-L1 inhibitor. It is approved to metastatic treat triple negative, PD-L1-positive breast cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04187872' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mbcalliance.org/marina-kaplan-project' target='_blank'>The Marina Kaplan Project: Breast Cancer Brain Metastases Initiative</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/pembrolizumab' target='_blank'>NCI: Pembrolizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/laser-interstitial-thermal-therapy.html' target='_blank'>MD Anderson: Laser Interstitial Thermal Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.monteris.com/healthcare-professionals/neuroblate-system/' target='_blank'>Monteris Medical: NeuroBlate System (LITT)</a> </li></ul>

107

NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03564782

PVSRIPO Vaccine in Stage II, III and IV Triple Negative Breast Cancer

Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Triple Negative Breast Cancer Scientific Title

Purpose

To look at the safety, effects (good and bad) and best dose of an experimental immunotherapy called PVSRIPO.

Who is this for?

Women with stage II-III triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options or who has metastatic (stage IV) TNBC with a local recurrence on the chest wall. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO, by injection, one time </li> <li class="seamTextUnorderedListItem">Surgery as planned</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO is a vaccine made out of a modified poliovirus. </li> <li class="seamTextUnorderedListItem">The vaccine uses the virus to get the immune system to kill cancer cells. </li> <li class="seamTextUnorderedListItem">You can not get polio from the vaccine.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03564782' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-oncolytic-poliovirus-pvs-ripo' target='_blank'>Cancer.gov: Recombinant oncolytic poliovirus PVS-RIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.istarioncology.com/our-science/pvs-ripo/' target='_blank'>Sponsor site: PVSRIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e12641' target='_blank'>Journal of Clinical Oncology: Recombinant oncolytic poliovirus combined with checkpoint blockade for breast cancer therapy</a> </li></ul>

108

NEAREST SITE: 2406 miles
UNC Lineberger Comprehensive Cancer Center
Chapel Hill,NC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03769415

HARMONY: Using a Genomic Test to Guide Treatment Decisions for Metastatic Breast Cancer

HARMONY: Harnessing the Analysis of RNA Expression and Molecular Subtype to Optimize Novel TherapY for Metastatic Breast Cancer Scientific Title

Purpose

To study if genomic testing affects which line of therapy doctors suggest people with metastatic breast cancer receive.

Who is this for?

People with metastatic (stage IV) breast cancer who have received no more than one line of therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PAM50 (Prosigna®) testing of your breast tumor, 1 time</li> <li class="seamTextUnorderedListItem">Results of the PAM50 test will be given to your treating doctor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The standard of care for treating metastatic breast cancer is to make treatment decisions based on clinical subtype. </li> <li class="seamTextUnorderedListItem">Clinical subtypes include hormone-positive (ER+ and/or PR+), HER2-positive (HER2+), and triple-negative (ER-, PR-, HER2-).</li> <li class="seamTextUnorderedListItem">The PAM50 (Prosigna®) is a genomic test approved for use in some women with early-stage breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Genomic testing looks at genetic mutations within your tumor. This gives your doctor a genetic subtype of your tumor. </li> <li class="seamTextUnorderedListItem">This trial is studying whether knowing a tumor's genetic subtype will affect how doctors treat people with metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Making treatment decisions based on genetic subtypes is not the standard of care.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03769415' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://unclineberger.org/octr/our-team/' target='_blank'>Study Coordinator Information: Terri Eubanks</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/genomic-tumor-testing/' target='_blank'>Metastatic Trial Talk: Genomic Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prosigna.com' target='_blank'>Veracyte Test Information Page: PAM50 (Prosigna®)</a> </li></ul>

109

NEAREST SITE: 2432 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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Participants will be assigned to 1 of 2 groups: Group 1 <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> Group 2 <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>

110

NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge
Basking Ridge,NJ

VISITS: Visits 5 days a week, for 3 weeks

PHASE: II

NCT ID: NCT02422498

Predicting Response to Cisplatin and Radiation Therapy in Women with Advanced Triple Negative Breast Cancer

A Phase II Trial of Homologous Recombination Repair Status as a Biomarker of Response in Locally Recurrent/Metastatic Triple Negative Breast Cancer Patients Treated With Concurrent Cisplatin and Radiation Therapy Scientific Title

Purpose

To study if testing a biopsy sample can predict the anti-cancer activity of a combination of the chemotherapy cisplatin and radiation therapy.

Who is this for?

Women with recurrent (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®), by IV, once a week, for 1-2 weeks</li> <li class="seamTextUnorderedListItem">Followed by radiation therapy, 5 days a week, for 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cisplatin (Platinol®) is a platinum-based chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Radiation therapy can be used to treat cancer cells that have spread to different parts of the body. </li> <li class="seamTextUnorderedListItem">Researchers have developed a test that may predict if your tumor will respond to cisplatin and radiation therapy. </li> <li class="seamTextUnorderedListItem">The test is performed on a biopsy (tissue sample) of the tumor, taken from the breast or elsewhere in the body.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02422498' 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://ww5.komen.org/BreastCancer/TripleNegativeBreastCancer.html' target='_blank'>Susan G. Komen: Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/radiation/metastatic' target='_blank'>Breastcancer.org: Radiation for Metastatic Breast Cancer</a> </li></ul>

111

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 8 visits over 2 months

PHASE: II

NCT ID: NCT04683679

Radiation Therapy, Immunotherapy, and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses Scientific Title

Purpose

To study the safety and anti-cancer activity of using radiation therapy and the immunotherapy pembrolizumab (Keytruda®) with or without the PARP inhibitor olaparib (Lynparza®).

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a PARP inhibitor or more than two systemic therapies for advanced disease. To enroll, you must not have a BRCA 1/2 mutation (inherited or tumor). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, for 6 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor or PD-1 inhibitor. It helps the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved to treat some advanced triple-negative breast cancer, but its use in this trial, however, is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a PARP inhibitor. It works by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat HER2-negative metastatic breast cancer in women with an inherited BRCA1/2 mutation. Its use in this trial, however, is considered experimental. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04683679' 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.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='https://www.breastcancer.org/research-news/fda-approves-keytruda-for-pd-l1-pos-tnbc' target='_blank'>Breastcancer.org: FDA Approves Immunotherapy Keytruda for PD-L1-Positive Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li></ul>

112

NEAREST SITE: 2539 miles
Memoral Sloan Kettering Basking Ridge
Basking Ridge,NJ

VISITS: 1 visit every other day for 6 or 10 days, then visits coincide with standard treatment

PHASE: II

NCT ID: NCT03808662

SBRT Radiation Therapy for Oligometastatic Breast Cancer

A Randomized Phase II Study Assessing the Efficacy of Local Ablative Radiation Therapy for Metastatic Breast and Lung Cancer Patients With Oligoprogressive Disease Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases.

Who is this for?

People with oligometastatic (stage IV) triple-negative (ER-, PR- and HER2-) or hormone receptor-positive (ER+ and/or PR+) breast cancer that has progressed on at least one other systemic treatment. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), every other day, for 3 or 5 sessions</li> <li class="seamTextUnorderedListItem">followed by standard of care treatment (decided by you and your physician)</li> </ul> Group 2: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment (decided by you and your physician)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is when there are only a small number of metastatic tumors in one or two other parts of the body. </li> <li class="seamTextUnorderedListItem">This study will compare the safety and effects (good or bad) of using stereotactic body radiation therapy (SBRT) to treat each site of metastases followed by a standard of care treatment, to a standard of care treatment alone. </li> <li class="seamTextUnorderedListItem">SBRT uses multiple radiation beams to deliver high doses of precision radiation directly to the tumor.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03808662' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.uclahealth.org/radonc/faqs-sbrt' target='_blank'>UCLA Health: SBRT FAQs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/diagnosis-treatment/cancer-treatments/radiation-therapy/what-sbrt' target='_blank'>Memorial Sloan Kettering Cancer Center: What is SBRT?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/oligometastasis' target='_blank'>NCI Dictionary of Cancer Terms: Oligometastasis</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/clinical-trials/18-431' target='_blank'>Memorial Sloan Kettering Cancer Center: Study information</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic Breast Cancer?</a> </li></ul>

113

NEAREST SITE: 2563 miles
Hackensack University Medical Center
Hackensack,NJ

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

PHASE: II

NCT ID: NCT05144698