New combo aims to outsmart resistant breast cancer

NCT ID NCT04762979

Ongoing Disease control Sponsor: Marina N Sharifi Source: ClinicalTrials.gov ↗

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

Summary

This phase 2 trial tests whether adding the targeted drug alpelisib to ongoing hormone therapy can help people with a specific genetic mutation (PIK3CA) in advanced breast cancer that has stopped responding to hormone therapy alone. About 44 participants will take daily alpelisib pills along with standard hormone-blocking injections or pills. The main goal is to see how long the cancer stays under control.

What this could mean

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

Active substance: Alpelisib (a targeted drug) combined with either fulvestrant or an aromatase inhibitor (hormone-blocking drugs)
What this could lead to: If successful, this could offer a new treatment option for people with a specific genetic mutation in advanced breast cancer that has stopped responding to hormone therapy alone.
What could go wrong: This is a small, early-phase trial (44 people) with no comparison group, so results may not apply broadly. Side effects from alpelisib can include high blood sugar, rash, and diarrhea.

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.

Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

HER2-NEGATIVE BREAST CANCER HORMONE RECEPTOR POSITIVE BREAST CARCINOMA PIK3CA MUTANT METASTATIC BREAST CANCER

Contacts and locations

Locations

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States
University of Illinois Cancer Center

Chicago, Illinois, 60612, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Wisconsin

Madison, Wisconsin, 53705, United States

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