Radiation and medication combination for breast cancer spread to the brain

Plain-English translation of NCT07396454 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing a new treatment approach for women with HER2-negative breast cancer that has spread to the brain. The study combines two treatments: radiation therapy (focused beams of radiation aimed at the brain tumors) with a daily oral medication called anlotinib, which works by blocking the growth of new blood vessels that feed cancer cells. Researchers want to see if using these two treatments together is more effective and safe than either one alone.

Currently, doctors don't have strong evidence about the best way to use newer cancer-fighting drugs alongside radiation therapy for brain metastases. This trial aims to fill that gap by testing whether this medication combined with radiation can improve outcomes for women with this particular type of advanced breast cancer.

Do you qualify?

You likely qualify if…

you are a woman aged 18 to 70 years old
you have been diagnosed with HER2-negative breast cancer that has spread to the brain, confirmed by MRI
you are in reasonably good overall health with a Karnofsky performance status score of 70 or higher
you have adequate organ and blood cell function (normal or near-normal blood counts, liver, and kidney function)
you are willing to use effective birth control during the study and for 6 months after treatment if you could become pregnant

You likely don't qualify if…

you have widespread cancer spread throughout the brain lining (leptomeningeal metastases) or bleeding in the brain tumors
you have seizures that are not well controlled by medication
you are unable to swallow pills or have severe digestive problems that would prevent you from taking oral medication
you are pregnant, breastfeeding, or unwilling to use contraception
you have other serious medical conditions that your doctor believes would make participation unsafe

What participation looks like

If you join this study, you will first receive radiation therapy to your brain, tailored to the size and location of your tumors. Within one week after radiation, you will begin taking the daily oral medication (anlotinib 12 mg) on a schedule where you take it for 2 weeks, then have 1 week off—repeating this cycle. You will need to visit the hospital regularly for blood tests, imaging scans (MRI), and check-ins with your doctor to monitor how well the treatment is working and to watch for any side effects. The study involves 39 women total and will track your progress over several months.

AI-generated summary from trial data · Jul 15, 2026 · Not medical advice

Trial locations(1 site)

China

The First Affiliated Hospital of Nanjing Medical University, Nanjing