Could immune activators revive treatment for Hard-to-Treat breast cancer?
NCT ID NCT03414658
First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether adding immune-boosting drugs (avelumab and utomilumab) to standard chemotherapy and targeted therapy can help people with HER2-positive metastatic breast cancer whose disease has worsened after prior treatments. Participants are randomly assigned to one of three drug combinations to see which best delays cancer growth. The study focuses on patients whose tumors still express HER2 but no longer respond to standard HER2-targeted therapies.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- a combination of trastuzumab, vinorelbine, avelumab, and utomilumab
- What this could lead to
- If successful, this could offer a new treatment option for people with HER2-positive metastatic breast cancer whose disease has stopped responding to standard therapies.
- What could go wrong
- This is a mid-stage trial with a small number of participants, so results may not confirm benefit. Adding immunotherapy can also cause immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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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
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Locations
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
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Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
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Duke University Medical Center
Durham, North Carolina, 27710, United States
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Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
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Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
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Montefiore Medical Center
The Bronx, New York, 10467, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
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University of California San Francisco
San Francisco, California, 94158, United States
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University of Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7305, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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University of Washington Fred Hutchinson Cancer Care
Seattle, Washington, 98109, United States
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Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
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