Clinical Trials

Below is a listing of Clinical Trials from the US National Cancer Institute (NCI) for breast cancer that accept men, which I update weekly.

To the right you see a button that allows you to search the trial listings of BreastCancerTrials.org for trials focused on metastatic disease and a link that allows you to do a search on that site for all the trials that accept men.

The list below was compiled by searching the NCI Clinical Trials data base with the term “breast – Male” in the “anatomic_sites” field using the published API, and restricting the results to Active trials with a status change in the last 6 months, which is hopefully the best way currently to find the newest trials (improvements coming in the database for this, I understand from the NCI’s API webpage.

This list therefore may contain the most recent trials to come on line for which men with breast cancer are eligible. Please explore the trials, and read details on their main pages on the NCI webpage, via the links provided.

This listing contains 26 trials, and was last updated on 2020-11-29

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Chemotherapy and Nivolumab Alone or in Combination with Cabiralizumab for the Treatment of Stage II-III Triple-Negative Breast Cancer

Phase Ib / II Study to Evaluate Safety and Tolerability of Cabiralizumab in Combination with Nivolumab and Neoadjuvant Chemotherapy in Patients with Localized Triple-Negative Breast Cancer

Phase I_II

This phase Ib / II trial studies the side effects of chemotherapy and nivolumab alone or in combination with cabiralizumab and to see how well they work in treating patients with stage II-III triple-negative breast cancer. Chemotherapy drugs, like paclitaxel and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabiralizumab may interfere with the ability of cancer cells to grow and spread. Adding cabiralizumab to chemotherapy and nivolumab may improve how a patient’s immune system becomes stimulated to fight cancer.

This trial may be offered at the following sites in the US (please check with center directly):

Siteman Cancer Center at Washington University, Saint Louis MO |

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Last status change to Active was on 2020-11-19.

For the complete listing see here: NCI-2020-06347

Pembrolizumab and Binimetinib in Treating Patients with Locally Advanced or Metastatic Triple Negative Breast Cancer

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

Phase I_II

This phase I / II trial studies the best dose of pembrolizumab and binimetinib and how well it works when given together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and binimetinib may work better in treating patients with triple negative breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

Mayo Clinic in Florida, Jacksonville FL | Mayo Clinic in Rochester, Rochester MN |

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Last status change to Active was on 2020-11-10.

For the complete listing see here: NCI-2017-00496

Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

A Phase 2, Multi-Cohort, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Intravenous Pembrolizumab Therapy With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

Phase II

This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (tavo) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral tavo-EP plus pembrolizumab with nab-paclitaxel (Abraxane®) chemotherapy. Subjects with TNBC and EP accessible cutaneous / subcutaneous disease will be enrolled in this study.

This trial may be offered at the following sites in the US (please check with center directly):

Stanford Cancer Institute Palo Alto, Palo Alto CA | Moffitt Cancer Center, Tampa FL | Fred Hutch / University of Washington Cancer Consortium, Seattle WA |

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Last status change to Active was on 2020-10-23.

For the complete listing see here: NCI-2018-02482

Testing the Addition of an Individualized Vaccine to Nab-Paclitaxel, Durvalumab and Tremelimumab and Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer

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

Phase II

This phase II trial studies how well nab-paclitaxel, durvalumab, and tremelimumab with or without personalized synthetic long peptide vaccine (neoantigen vaccine) works in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. It is not yet known whether giving nab-paclitaxel, durvalumab, and tremelimumab with or without neoantigen vaccine will work better in treating patients with triple negative breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

Yale University Cancer Center LAO, New Haven CT |

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Last status change to Active was on 2020-10-16.

For the complete listing see here: NCI-2018-01581

Olaparib, Palbociclib, and Fulvestrant in Treating Patients with BRCA Mutation-Associated, Hormone Receptor-Positive, and HER2-Negative Advanced Breast Cancer

A Phase I / II Trial of Olaparib, Palbociclib and Fulvestrant in Patients with BRCA Mutation-Associated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Metastatic Breast Cancer

Phase I_II

This phase I / II trial studies the best dose and side effects of palbociclib when given together with olaparib and fulvestrant, and to see how well they work in treating patients with BRCA mutation-associated, hormone receptor-positive, HER2-negative breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and cannot be removed by surgery, or has spread to other places in the body (advanced). Palbociclib and olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anti-hormone therapy consisting of fulvestrant may prevent breast cancer cell growth by blocking estrogen and progesterone receptor stimulation. This trial studies the effectiveness of the combination of palbociclib, olaparib and fulvestrant.

This trial may be offered at the following sites in the US (please check with center directly):

Memorial Sloan Kettering Cancer Center, New York NY | University of Pennsylvania / Abramson Cancer Center, Philadelphia PA |

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Last status change to Active was on 2020-10-15.

For the complete listing see here: NCI-2019-04210

A Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer

Phase III

This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative locally advanced (recurrent or progressed) or metastatic breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

University of Colorado Hospital, Aurora CO |

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Last status change to Active was on 2020-10-14.

For the complete listing see here: NCI-2020-08420

SAR439859 Plus Palbociclib as First Line Therapy for Patients With ER(+) HER2(-) Advanced Breast Cancer

A Randomized, Multicenter, Double-blind Phase 3 Study of SAR439859 Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Phase III

Primary Objective: To determine whether SAR439859 in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with ER+, HER2- advanced breast cancer who have not received any prior systemic anticancer therapies for advanced disease. Secondary Objective: – To compare the overall survival in both treatment arms – To evaluate the objective response rate in both treatment arms – To evaluate the duration of response in both treatment arms – To evaluate the clinical benefit rate in both treatment arms – To evaluate the pharmacokinetics of SAR439859, goserelin, and palbociclib – To evaluate health-related quality of life in both treatment arms – To evaluate the time to first chemotherapy in both treatment arms – To evaluate safety in both treatment arms

This trial may be offered at the following sites in the US (please check with center directly):

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA | University of Iowa / Holden Comprehensive Cancer Center, Iowa City IA | University of Kansas Cancer Center, Kansas City KS | Wake Forest University Health Sciences, Winston-Salem NC | Rutgers Cancer Institute of New Jersey, New Brunswick NJ |

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Last status change to Active was on 2020-10-01.

For the complete listing see here: NCI-2020-07111

A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

A Phase Ib, Open-Label, Multicohort Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Patients With Triple-Negative Breast Cancer

Phase I

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).

This trial may be offered at the following sites in the US (please check with center directly):

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh PA |

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Last status change to Active was on 2020-09-28.

For the complete listing see here: NCI-2020-11524

Sacituzumab Govitecan Alone or in Combination with Pembrolizumab for the Treatment of Hormone Receptor+, HER2-, and PD-L1+ Metastatic Breast Cancer

Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan with or without Pembrolizumab in Hormone Receptor-Positive (HR+) / HER2- Metastatic Breast Cancer (MBC)

Phase II

This phase II trial studies the effect of sacituzumab govitecan alone or in combination with pembrolizumab in treating patients with hormone receptor positive (HR+) / HER2 negative, PD-L1 positive breast cancer that has spread to other places in the body (metastatic). Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody, which are proteins normally made by the immune system that bind to substances that don’t belong in the body to prevent harm. The antibody in this study binds to certain types of cancer tumors, including HR+ / HER2- tumors. Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body’s own immune system to seek out and destroy tumors. Giving sacituzumab govitecan alone or in combination with pembrolizumab may work better in delaying the worsening of HR+ / HER2- breast cancers that are also positive for PD-L1.

This trial may be offered at the following sites in the US (please check with center directly):

Dana-Farber Cancer Institute, Boston MA | Brigham and Women’s Hospital, Boston MA |

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Last status change to Active was on 2020-09-23.

For the complete listing see here: NCI-2020-07741

A Vaccine (MV-s-NAP) for the Treatment of Patients with Invasive Metastatic Breast Cancer

Phase I Trial of Intratumoral Administration of a Measles Virus Derivative Expressing the Helicobacter Pylori Neutrophil-Activating Protein (NAP) (MV-s-NAP) in Patients with Metastatic Breast Cancer

Phase I

This phase I trial investigates the side effects and best dose of using a modified measles virus, MV-s-NAP, in treating patients with invasive breast cancer that has spread to other places in the body (metastatic). Both the unmodified vaccination measles virus (MV-Edm) and this modified virus (MV-s-NAP) have been shown to multiply in and destroy breast cancer cells in the test tube and in research mice. MV-s-NAP has been altered by having an extra gene (piece of deoxyribonucleic acid [DNA]) so that virus can make a protein called helicobacter pylori neutrophil activating protein (NAP) which is normally expressed in inflammatory reactions. Monitoring blood, urine, tissue, and throat swab samples, and using imaging tests may help to determine whether MV-s-NAP has any impact on the amount of disease present in metastatic breast cancer patients.

This trial may be offered at the following sites in the US (please check with center directly):

Mayo Clinic in Rochester, Rochester MN |

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Last status change to Active was on 2020-09-23.

For the complete listing see here: NCI-2020-06009

DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer

A Phase I, Open-Label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of DZD1516 in Combination With Trastuzumab and Capecitabine, or DZD1516 in Combination With T-DM1, in Patients With Metastatic HER2 Positive (HER2+) Breast Cancer

Phase I

DZD1516 is an oral, blood brain barrier penetrable, selective HER2 tyrosine kinase inhibitor. This study is designed to evaluate the safety and tolerability of DZD1516 in patients with metastatic HER2 positive breast cancer who have progressed following prior therapy. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy and in combination with trastuzumab and / or capecitabine, or in combination with T-DM1

This trial may be offered at the following sites in the US (please check with center directly):

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA |

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Last status change to Active was on 2020-09-21.

For the complete listing see here: NCI-2020-06355

Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients with Stage I-III HER2 Positive Breast Cancer

Phase II Trial of Rifaximin in Patients with Early Stage HER2 Positive Breast Cancer with Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy

Phase II

This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer. Rifaximin may reduce the incidence and severity of pertuzumab induced gastrointestinal toxicities without interrupting or delaying the chemotherapy schedule.

This trial may be offered at the following sites in the US (please check with center directly):

Mayo Clinic in Florida, Jacksonville FL |

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Last status change to Active was on 2020-09-18.

For the complete listing see here: NCI-2020-00332

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Phase II

This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.

This trial may be offered at the following sites in the US (please check with center directly):

City of Hope Comprehensive Cancer Center, Duarte CA | Emory University Hospital / Winship Cancer Institute, Atlanta GA | Fred Hutch / University of Washington Cancer Consortium, Seattle WA |

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Last status change to Active was on 2020-09-17.

For the complete listing see here: NCI-2020-08177

Cryoimmunotherapy and Pembrolizumab for the Treatment of Locally Advanced Unresectable or Cutaneous Metastatic Breast Cancer

Phase IB Pilot Study of Epicutaneous Cryoimmunotherapy Combined with Pembrolizumab for Cutaneous Metastatic Breast Cancer

Phase I

This phase IB trial studies the side effect of cryoimmunotherapy (cryotherapy, GM-CSF, and imiquimod) with pembrolizumab for the treatment of breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) or has spread to the skin (cutaneous metastatic). Cryotherapy is a procedure in which extremely cold liquid (liquid nitrogen) is used to freeze and destroy abnormal tissue. GM-CSF and imiquimod may help the immune system kill abnormal cells, including tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cryoimmunotherapy with pembrolizumab may work better in treating breast cancer that includes skin lesions.

This trial may be offered at the following sites in the US (please check with center directly):

Siteman Cancer Center at Washington University, Saint Louis MO |

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Last status change to Active was on 2020-09-14.

For the complete listing see here: NCI-2019-08917

Ribociclib in Treating Patients with Estrogen Receptor Positive Breast Cancer

Phase II Study of CDK 4 / 6 Inhibitor, LEE011 (Ribociclib), in Combination with Adjuvant Endocrine Therapy at Varying Duration for ER-Positive Breast Cancer (LEADER)

Phase II

This randomized phase II trial studies how well ribociclib works in treating patients with estrogen receptor positive breast cancer. Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

This trial may be offered at the following sites in the US (please check with center directly):

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA | Beth Israel Deaconess Medical Center, Boston MA | Massachusetts General Hospital Cancer Center, Boston MA | Mass General / North Shore Cancer Center, Danvers MA | Newton-Wellesley Hospital, Newton MA |

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Last status change to Active was on 2020-09-03.

For the complete listing see here: NCI-2018-00166

A Study of AL101 Monotherapy in Patients With Notch Activated Triple Negative Breast Cancer

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

Phase II

The current study is designed to evaluate the efficacy and safety of AL101 monotherapy in subjects with Notch-activated recurrent or metastatic TNBC; Notch activation will be determined by a Next Generation Sequencing (NGS) test.

This trial may be offered at the following sites in the US (please check with center directly):

University of California San Francisco, San Francisco CA | Case Comprehensive Cancer Center, Cleveland OH |

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Last status change to Active was on 2020-08-14.

For the complete listing see here: NCI-2020-07638

Testing the Addition of Copanlisib to Eribulin for the Treatment of Advanced-Stage Triple Negative 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

Phase I_II

This phase I / II trial studies the side effects and best dose of copanlisib and how well it works when given together with eribulin in treating patients with triple negative breast cancer that has spread to other places in the body (advanced stage). Copanlisib stops the growth of a protein called PI3K, which is often changed in tumor cells and causes resistance to treatment. Chemotherapy drugs, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving copanlisib and eribulin may work better in treating advanced stage triple negative breast cancer compared to eribulin alone.

This trial may be offered at the following sites in the US (please check with center directly):

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Last status change to Active was on 2020-08-10.

For the complete listing see here: NCI-2020-02319

Durvalumab and Combination Chemotherapy in Treating Patients with Stage I-III Triple Negative Breast Cancer

Single Arm Neoadjuvant Phase I / II Study of MEDI4736 (Anti-PD-L1 Antibody) Concomitant with Weekly Nab-Paclitaxel and Dose Dense Doxorubicin / Cyclophosphamide (AC) Chemotherapy for Clinical Stage I-III Triple Negative Breast Cancer

Phase I_II

This phase I / II trial studies the side effects and best dose of durvalumab when given together with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide and to see how well they work in treating patients with stage I-III breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor (HER)2 / neu protein. Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab together with paclitaxel albumin-stabilized nanoparticle formulation, doxorubicin hydrochloride, and cyclophosphamide may kill more tumor cells.

This trial may be offered at the following sites in the US (please check with center directly):

Yale University, New Haven CT |

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Last status change to Active was on 2020-07-24.

For the complete listing see here: NCI-2016-00070

Pembrolizumab and Mifepristone in Treating Patients with Metastatic or Locally Advanced and Unresectable HER2-Negative Breast Cancer

Phase II Study of Pembrolizumab and Mifepristone in Patients with Advanced HER2-Negative Breast Cancer

Phase II

This phase II trial studies how well pembrolizumab and mifepristone works in treating patients with HER2-negative breast cancer that has spread to other places in the body, or to nearby tissues or lymph nodes and cannot be removed by surgery. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Hormone therapy using mifepristone may fight breast cancer by lowering the amount of progesterone and glucocorticoid the body makes. Giving pembrolizumab and mifepristone may work better in treating patients with HER2-negative breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

University of Chicago Comprehensive Cancer Center, Chicago IL | NorthShore University HealthSystem-Evanston Hospital, Evanston IL |

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Last status change to Active was on 2020-07-22.

For the complete listing see here: NCI-2018-00004

Testing the Addition of Pembrolizumab to Sacituzumab Govitecan for the Treatment of PD-L1 Negative Locally Advanced Unresectable or Metastatic Triple Negative Breast Cancer, Saci-IO TNBC Study

Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan with or without Pembrolizumab in PD-L1-Negative Metastatic Triple Negative Breast Cancer (TNBC)

Phase II

This phase II trial investigates how well the addition of pembrolizumab to sacituzumab govitecan works in treating patients with PD-L1 negative triple negative breast cancer that has spread from its original site of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally advanced unresectable) or to other places in the body (metastatic). Sacituzumab govitecan is composed of a chemotherapy drug, called irinotecan, which is attached to an antibody. Antibodies are proteins normally made by the immune system that bind to substances that don’t belong in the body to prevent harm. Sacituzumab govitecan binds to the cancer cells and kills them. Pembrolizumab is an immunotherapy, called an anti-PD-1 or a checkpoint inhibitor, and is an antibody (a type of human protein) designed to allow the body’s own immune system to seek out and destroy tumors. This trial is being done to evaluate the effectiveness of sacituzumab govitecan alone or in combination with pembrolizumab, in delaying the worsening of triple negative breast cancers that are PD-L1 negative.

This trial may be offered at the following sites in the US (please check with center directly):

Dana-Farber Cancer Institute, Boston MA | Brigham and Women’s Hospital, Boston MA |

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Last status change to Active was on 2020-07-20.

For the complete listing see here: NCI-2020-06546

Paclitaxel and Pertuzumab with Margetuximab or Trastuzumab for the Treatment of HER2-Positive Stage II-III Invasive Breast Cancer, The MARGOT Trial

MARGetuximab or Trastuzumab (MARGOT): A Phase II Study Comparing Neoadjuvant Paclitaxel / Margetuximab / Pertuzumab to Paclitaxel / Trastuzumab / Pertuzumab in Patients with Stage II-III HER2-Positive Breast Cancer

Phase II

This phase II trial investigates how well paclitaxel and pertuzumab with margetuximab or trastuzumab works in treating patients with HER2-positive stage II-III invasive breast cancer. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Trastuzumab and margetuximab are both forms of targeted therapy because they attach themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and margetuximab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body’s immune system. This trial is being done to determine how well HER2-positive breast cancer responds to pre-operative treatment using one of two different combination of drugs as a treatment for this diagnosis.

This trial may be offered at the following sites in the US (please check with center directly):

Brigham and Women’s Hospital, Boston MA | Dana-Farber Cancer Institute, Boston MA |

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Last status change to Active was on 2020-07-13.

For the complete listing see here: NCI-2020-06704

Sacituzumab Govitecan before Surgery for the Treatment of Localized Triple-Negative Breast Cancer, The NeoSTAR Trial

A Phase 2 Study of Response-Guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients with Localized Triple-Negative Breast Cancer (NeoSTAR)

Phase II

This phase II trial studies whether sacituzumab govitecan is effective and safe before surgery for the treatment of patients with triple-negative breast cancer that has not spread to other parts of the body (localized). Sacituzumab govitecan is an antibody-drug conjugate which means it’s made up of an antibody attached to an anticancer drug. An antibody is a protein normally made by the immune system (the system in the body that fights off diseases). Sacituzumab govitecan may work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent tumor cells from growing / spreading.

This trial may be offered at the following sites in the US (please check with center directly):

Massachusetts General Hospital Cancer Center, Boston MA | Beth Israel Deaconess Medical Center, Boston MA | Dana-Farber Cancer Institute, Boston MA | Mass General / North Shore Cancer Center, Danvers MA | Newton-Wellesley Hospital, Newton MA |

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Last status change to Active was on 2020-07-02.

For the complete listing see here: NCI-2020-06537

FES-PET / CT Scans for the Optimization of Tamoxifen Dose in Patients with Estrogen Receptor Positive, ESR1 Mutant Metastatic or Unresectable Breast Cancer

A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients with ESR1 Mutations

Phase O

This early phase I trial studies how well FES-PET / CT scans work in determining the best dose of tamoxifen for treating patients with estrogen receptor positive, ESR1 gene mutant breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). FES is a low-dose radioactive form of estrogen and can “light up” where estrogen receptor positive cancer is present in the body. Diagnostic procedures such as FES-PET / CT, may help to determine the optimal dose of tamoxifen and prevent treatment resistance due to underdosing on standard dose of tamoxifen in patients with breast cancer.

This trial may be offered at the following sites in the US (please check with center directly):

University of Wisconsin Hospital and Clinics, Madison WI |

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Last status change to Active was on 2020-07-01.

For the complete listing see here: NCI-2019-07924

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Phase III

The purpose of this two parts multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.

This trial may be offered at the following sites in the US (please check with center directly):

City of Hope Comprehensive Cancer Center, Duarte CA | UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA | University of California San Francisco, San Francisco CA | Northwestern University, Chicago IL | Fred Hutch / University of Washington Cancer Consortium, Seattle WA | University of Wisconsin Hospital and Clinics, Madison WI |

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Last status change to Active was on 2020-06-25.

For the complete listing see here: NCI-2020-02351

Stereotactic Radiosurgery with Abemaciclib, Ribociclib, or Palbociclib in Treating Patients with Hormone Receptor Positive Breast Cancer with Brain Metastases

Evaluation of Radiosurgery with Concurrent Cyclin-Dependent Kinase 4 / 6 Inhibitors in the Treatment of Brain Metastases

Phase I

This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain metasteses). Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Abemaciclib, ribociclib, and palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib, ribociclib, or palbociclib concurrently with stereotactic radiosurgery may reduce the side effects and / or increase the response to each of the therapies.

This trial may be offered at the following sites in the US (please check with center directly):

Emory University Hospital / Winship Cancer Institute, Atlanta GA | Emory Saint Joseph’s Hospital, Atlanta GA | Grady Health System, Atlanta GA |

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Last status change to Active was on 2020-06-12.

For the complete listing see here: NCI-2019-02251

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Without PIK3CA Mutation

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 (PTEN) Loss Without PIK3CA Mutation

Phase III

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)

This trial may be offered at the following sites in the US (please check with center directly):

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles CA | Case Comprehensive Cancer Center, Cleveland OH |

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Last status change to Active was on 2020-06-05.

For the complete listing see here: NCI-2020-02353