New medication combined with chemotherapy for advanced breast cancer that has spread to the brain

Plain-English translation of NCT05535413 on ClinicalTrials.gov ↗ · Source last updated April 2025 · Translation generated June 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This trial is testing a new medication called (a chemotherapy pill) in patients with advanced breast cancer that has spread to the brain. The study wants to see how well this combination treatment works and whether it is safe for people whose breast cancer is HER2-negative, meaning their tumors lack a specific protein called HER2.

Many patients with advanced breast cancer that spreads to the brain have limited treatment options. This medication may be able to reach cancer cells in the brain better than other treatments, offering hope to patients who need new approaches.

Do you qualify?

You likely qualify if…

you are between 18 and 70 years old
you have been diagnosed with HER2-negative breast cancer that has returned or spread to other parts of your body, including the brain
you have at least one measurable tumor in your brain that is at least 10 millimeters in size
your overall health and ability to function are good enough (an ECOG score of 0 to 2)
your blood counts, liver function, and kidney function are near normal or acceptable for the study

You likely don't qualify if…

your breast cancer tumors are HER2-positive
you have been diagnosed with another type of cancer in the past 5 years (except for certain skin cancers or cervical pre-cancers)
you have had chemotherapy, radiation, surgery, or other cancer treatment within 4 weeks before joining the study
you need immediate surgery on major organs or have had major surgery or serious injury in the past 4 weeks
you are pregnant or plan to become pregnant during the study

What participation looks like

If you join this trial, you will take as part of your cancer treatment. The study will happen across multiple hospitals and take place over several months, with regular clinic visits to check how you are doing, monitor your blood work, and get scans of your brain to see how the cancer is responding. Your doctors will watch closely for any side effects and keep detailed records of how well the treatment is working.

AI-generated summary from trial data · Jun 19, 2026 · Not medical advice

Trial locations(1 site)

China

Quchang Ouyang, Changsha