Testing a new breast cancer medication in women with a specific genetic mutation

Plain-English translation of NCT05683418 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This study is testing a new medication called designed to treat a specific type of breast cancer. The trial will first figure out the right dose and schedule (once or twice daily), then test whether the medication works better when combined with other standard breast cancer treatments. This medication targets cancer cells that have a particular genetic change, which may make it more effective for certain patients.

Most women with this type of breast cancer eventually stop responding to standard hormonal treatments, and their cancer comes back or spreads. This new medication is designed to work differently by targeting a genetic change found in about half of these cancers, potentially offering hope to women who have limited options after previous treatments.

Do you qualify?

You likely qualify if…

you have been diagnosed with hormone-positive, HER2-negative breast cancer that has come back locally, returned after treatment, or spread to other parts of your body
you have received no more than three previous lines of chemotherapy or targeted drugs for advanced breast cancer
your cancer has been confirmed to have a PIK3CA mutation or amplification through genetic testing at a certified laboratory
you are 18 years or older and in generally good health with adequate organ function
you have measurable disease that can be tracked on imaging scans or is visible to doctors
your blood sugar and blood sugar control (HbA1c) are at acceptable levels

You likely don't qualify if…

you have type 1 diabetes or type 2 diabetes that is not well controlled
your breast cancer has spread to your brain or central nervous system
your cancer cells have a PTEN genetic mutation
you are unable or unwilling to provide written consent to participate
you have a life expectancy of less than 6 months as determined by your doctor

What participation looks like

You would take the new medication by mouth as a pill, either once or twice daily depending on which dose group you're in. The study has two phases: first, doctors determine the best dose, then they test whether adding other standard breast cancer drugs improves results. You would have regular clinic visits for blood tests, physical exams, and imaging scans to check how your cancer is responding and monitor for any side effects. You would continue treatment until your cancer stops responding, you experience unacceptable side effects, or you and your doctor decide to stop for another reason.

AI-generated summary from trial data · Jun 18, 2026 · Not medical advice

Trial locations(18 sites)

United States

Northwestern Memorial Hospital, Chicago, Illinois

Beth Israel Deaconess Medical Center, Boston, Massachusetts

Dana-Farber Cancer Institute, Boston, Massachusetts

Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada

University of Pennsylvania, Philadelphia, Pennsylvania