New drug combo targets hidden HER2 in breast cancer brain tumors

NCT ID NCT04965064

Recruiting now Disease control Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether a combination of two drugs, neratinib and capecitabine, can help people with HER2-negative breast cancer that has spread to the brain. The study enrolls 22 adults whose tumors show abnormal HER2 activity on a special test. Researchers will measure how long participants live and how long it takes for the cancer to worsen in the brain.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: neratinib and capecitabine
What this could lead to: If successful, this could offer a new treatment option for breast cancer patients with brain metastases whose tumors show hidden HER2 activity, potentially improving survival and delaying brain tumor progression.
What could go wrong: This is a small, early-phase trial with only 22 participants, so results may not apply to everyone. The combination of drugs can cause side effects like diarrhea, nausea, and hand-foot syndrome, and the treatment may not work for all patients.

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Conditions

The condition(s) this trial relates to.

brain cancer breast cancer breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BREAST CANCER

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

University of Rochester
RECRUITING

Rochester, New York, 14642, United States

Contact Email: •••••@•••••

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