New drug cocktail targets aggressive breast cancer

NCT ID NCT05230810

Ongoing Disease control Sponsor: Criterium, Inc. Source: ClinicalTrials.gov ↗

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

Summary

This study tests a combination of two targeted drugs, tucatinib and alpelisib, in people with a specific genetic mutation (PIK3CA) and HER2-positive advanced breast cancer. About 40 adults whose cancer has spread or cannot be removed will take these pills daily. The goal is to see if the combo is safe and can slow cancer growth.

What this could mean

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

Active substance: Tucatinib and alpelisib (targeted cancer pills), plus fulvestrant (injection) for some patients
What this could lead to: If it works, this could offer a new treatment option for people with a hard-to-treat form of advanced breast cancer.
What could go wrong: This is an early-phase trial with only 40 participants, so results may not apply widely. The drug combination may cause side effects or fail to slow the cancer.

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 positive breast carcinoma

As listed by the trial registrant

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

HER2-POSITIVE METASTATIC BREAST CANCER

Contacts and locations

Locations

Cancer Care & Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States
Louisiana State University Health Sciences Center

New Orleans, Louisiana, 70112, United States
University of Colorado Cancer Center

Aurora, Colorado, 80045, United States
University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

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