New combo therapy targets breast cancer brain metastases in early trial

NCT ID NCT03807765

Completed Disease control Sponsor: H. Lee Moffitt Cancer Center and Research Institute Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested whether combining stereotactic radiosurgery (precise radiation) with the immunotherapy drug nivolumab (Opdivo) is safe and can shrink tumors in people with breast cancer that has spread to the brain. Fourteen participants received the combination. The main goal was to check for serious neurological side effects, not to prove the treatment works.

What this could mean

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

Active substance: Nivolumab (Opdivo) and stereotactic radiosurgery
What this could lead to: If this combination proves safe and effective, it could offer a new treatment option for breast cancer that has spread to the brain.
What could go wrong: This is a very early phase 1 trial with only 14 participants, focused on safety. It is not designed to prove the treatment works, and there are risks of serious neurological 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.

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

As listed by the trial registrant

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

BRAIN METASTASES METASTATIC BREAST CANCER

Contacts and locations

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

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