Promising combo for tough breast cancer hits snag: trial ends early
NCT ID NCT04958785
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called magrolimab combined with chemotherapy for people with advanced triple-negative breast cancer that cannot be removed by surgery. The goal was to see if the combination was safe and worked better than chemotherapy alone. The trial was terminated early, so final results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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92 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Oct 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion criteria: * Adequate performance status, hematologic, renal and liver function. * Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1 * Cohort 1: Individuals with previously untreated with systemic therapy for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) that are considered programmed cell death ligand 1 (PD-L1) negative (as determined by an approved test according to local regulations). * Cohort 2: Individuals with unresectable, locally advanced or metastatic breast cancer with a diagnosis of TNBC who have received at least 1 and no more than 2 prior lines of systemic therapy in the unresectable, locally advanced or metastatic setting. Individuals must have been previously treated with a taxane in any setting. Individuals with tumors that are considered positive for PD-L1 expression (as determined by an approved test according to local regulations) must have received an immune checkpoint inhibitor for a prior-line of treatment for unresectable locally advanced/metastatic TNBC. Key Exclusion Criteria: * Positive serum pregnancy test or breastfeeding female. * Active central nervous system (CNS) disease. Individuals with asymptomatic and stable, treated CNS lesions (who have been off steroids, radiation and/or surgery and/or other CNS-directed therapy for at least 4 weeks) are allowed. * Red blood cell (RBC) transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criteria. * History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months. * Prior treatment with cluster of differentiation 47 (CD47) or signal regulatory protein alpha-targeting agents. * Known inherited or acquired bleeding disorders. * Cohort 1 only: Disease progression within 6 months following neoadjuvant/adjuvant therapy. * Cohort 2 only: * Individuals with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and Individuals with a history of bowel obstruction or gastrointestinal perforation within 6 months of enrollment. * Individuals who previously received topoisomerase I inhibitors or antibody-drug conjugates containing a topoisomerase inhibitor. * High-dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of Cycle 1 Day 1. * Have not recovered (ie, ≥ Grade 2 is considered not recovered) from adverse events (AEs) due to a previously administered agent. * Note: Individuals with any grade of neuropathy, alopecia, hypo- or hyperthyroidism, or other endocrinopathies that are well controlled with hormone replacement are an exception to this criterion and will qualify for the study. * Note: if individuals received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allina Health Cancer Institute
Minneapolis, Minnesota, 55407, United States
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Asan Medical Center
Seoul, 5505, South Korea
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Astera Cancer Care
East Brunswick, New Jersey, 08816, United States
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Ballarat Oncology & Haematology Services
Wendouree, Victoria, 3355, Australia
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Barwon Health- University Hospital Geelong
Geelong, Victoria, '03220, Australia
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Box Hill Hospital
Box Hill, Victoria, 3128, Australia
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Cairns and Hinterland Hospital and Health Service
Cairns, Queensland, 4870, Australia
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Cancer Research SA
Adelaide, South Australia, 5000, Australia
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Chang Gung Memorial Hospital, Linkou
Guishan District, 131, Taiwan
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Changhua Christian Hospital
Changhua, 50006, Taiwan
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Charleston Oncology
Charleston, South Carolina, 29414, United States
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Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
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Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112, United States
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Sanmin District, 80778, Taiwan
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Mayo Clinic
Phoenix, Arizona, 85054, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center
New York, New York, 10016, United States
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National Cancer Center
Goyang-si, 10408, South Korea
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National Taiwan University Hospital
Tapiei, Taiwan
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Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
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Orchard Healthcare Research Inc
Skokie, Illinois, 60077, United States
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Peninsula Health
Frankston, Victoria, 3199, Australia
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Prince of Wales Hospital
New Territories, Hong Kong
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Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
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Princess Margaret Hospital
Kowloon, Hong Kong
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Providence Medical Foundation
Fullerton, California, 92835, United States
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Providence Medical Foundation
Santa Rosa, California, 95403, United States
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Queen Mary Hospital
Hong Kong, Hong Kong
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Saint John's Cancer Institute
Santa Monica, California, 90404, United States
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Samsung Medical Center
Gangnam-Gu, 06351, South Korea
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Seoul National University Hospital
Jongrogu, 110-744, South Korea
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Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
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Southeastern Regional Medical Center, LLC
Newnan, Georgia, 30265, United States
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St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
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Stony Brook University
Stony Brook, New York, 11794, United States
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Taipei Veterans General Hospital
Beitou District, 11257, Taiwan
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The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
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University Cancer & Blood Center,LLC
Athens, Georgia, 30607, United States
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University College London
London, WC1E 6BT, United Kingdom
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University Hospitals of Leicester NHS Trust
Leicester, LE1 5WW, United Kingdom
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University of California San Francisco
San Francisco, California, 94115, United States
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University of the Sunshine Coast
Sippy Downs, Queensland, 4556, Australia
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Winship Cancer Institute Emory University
Atlanta, Georgia, 30322, United States
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Women's Cancer Care
Fresno, California, 93710, United States
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Other studies related to the condition(s) this trial covers.
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