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

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02115, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7305, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Washington Fred Hutchinson Cancer Care

    Seattle, Washington, 98109, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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