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Promising combo for tough breast cancer hits snag: trial ends early

NCT ID NCT04958785

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

92 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Allina Health Cancer Institute

    Minneapolis, Minnesota, 55407, United States

  • Asan Medical Center

    Seoul, 5505, South Korea

  • Astera Cancer Care

    East Brunswick, New Jersey, 08816, United States

  • Ballarat Oncology & Haematology Services

    Wendouree, Victoria, 3355, Australia

  • Barwon Health- University Hospital Geelong

    Geelong, Victoria, '03220, Australia

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Cairns and Hinterland Hospital and Health Service

    Cairns, Queensland, 4870, Australia

  • Cancer Research SA

    Adelaide, South Australia, 5000, Australia

  • Chang Gung Memorial Hospital, Linkou

    Guishan District, 131, Taiwan

  • Changhua Christian Hospital

    Changhua, 50006, Taiwan

  • Charleston Oncology

    Charleston, South Carolina, 29414, United States

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Sanmin District, 80778, Taiwan

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • NYU Investigational Pharmacy, Laura & Isaac Perlmutter Cancer Center

    New York, New York, 10016, United States

  • National Cancer Center

    Goyang-si, 10408, South Korea

  • National Taiwan University Hospital

    Tapiei, Taiwan

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Orchard Healthcare Research Inc

    Skokie, Illinois, 60077, United States

  • Peninsula Health

    Frankston, Victoria, 3199, Australia

  • Prince of Wales Hospital

    New Territories, Hong Kong

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Hospital

    Kowloon, Hong Kong

  • Providence Medical Foundation

    Fullerton, California, 92835, United States

  • Providence Medical Foundation

    Santa Rosa, California, 95403, United States

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Saint John's Cancer Institute

    Santa Monica, California, 90404, United States

  • Samsung Medical Center

    Gangnam-Gu, 06351, South Korea

  • Seoul National University Hospital

    Jongrogu, 110-744, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Southeastern Regional Medical Center, LLC

    Newnan, Georgia, 30265, United States

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Taipei Veterans General Hospital

    Beitou District, 11257, Taiwan

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX, United Kingdom

  • University Cancer & Blood Center,LLC

    Athens, Georgia, 30607, United States

  • University College London

    London, WC1E 6BT, United Kingdom

  • University Hospitals of Leicester NHS Trust

    Leicester, LE1 5WW, United Kingdom

  • University of California San Francisco

    San Francisco, California, 94115, United States

  • University of the Sunshine Coast

    Sippy Downs, Queensland, 4556, Australia

  • Winship Cancer Institute Emory University

    Atlanta, Georgia, 30322, United States

  • Women's Cancer Care

    Fresno, California, 93710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.