Promising combo for brain metastases hits early snag: trial ends after just one patient

NCT ID NCT05553522

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial aimed to see if combining three drugs (tucatinib, trastuzumab, and capecitabine) with precise radiation (SRS) is safe for people with HER2-positive breast cancer that has spread to the brain. Only one person enrolled before the study was terminated, so we have very little information. The main goal was to find the safest dose and watch for side effects like low blood counts or radiation-related issues.

What this could mean

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

Active substance

tucatinib, trastuzumab, capecitabine, and stereotactic radiosurgery

What this could lead to

If it works, this could point toward a treatment that controls brain metastases from HER2-positive breast cancer using a combination of targeted drugs and precise radiation.

What could go wrong

This was a very early Phase 1 trial with only 1 participant and was terminated, so we have almost no data on safety or effectiveness. The combination may cause serious side effects like low blood counts or lung inflammation.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

brain cancer HER2 positive breast carcinoma metastatic malignant neoplasm in the brain

As listed by the trial registrant

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

Contacts and locations

Locations

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176, United States