New drug cocktail targets Hard-to-Treat breast cancer mutation

NCT ID NCT04253561

Completed Disease control Sponsor: SOLTI Breast Cancer Research Group Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug, ipatasertib, added to two existing breast cancer medicines (trastuzumab and pertuzumab) in 17 people with advanced HER2-positive breast cancer that has a specific genetic change (PIK3CA mutation). The main goal was to find the safest dose of ipatasertib when used in this combination. Researchers also tracked side effects and early signs of tumor shrinkage.

What this could mean

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

Active substance: Ipatasertib (an AKT inhibitor) combined with trastuzumab and pertuzumab
What this could lead to: If successful, this combination could offer a new treatment option for people with a specific genetic mutation in HER2-positive breast cancer that has spread.
What could go wrong: This is a very early, small Phase 1 study with only 17 participants, focused on finding the right dose and checking safety. It is not designed to prove the treatment works, and side effects are possible.

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.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

METASTATIC BREAST CANCER

Contacts and locations

Locations

Centro Integral Oncológico Clara Campal (CIOCC)

Madrid, Madrid, Spain
Comp. Hosp.Univ. Santiago (Chus)

Santiago de Compostela, La Coruña, Spain
Fundación Instituto Valenciano de Oncología

Valencia, Valencia, Spain
H.Univ. Arnau de Vilanova de Lleida

Lleida, Lleida, Spain
Hospital Universitario Doce de Octubre

Madrid, Madrid, Spain
Hospital Universitario Virgen del Rocio

Seville, Sevilla, Spain
Hospital Universitario del Vall d' Hebron

Barcelona, Barcelona, Spain
Hospital Virgen de Macarena

Seville, Sevilla, Spain
ICO Badalona

Badalona, Barcelona, Spain
MD Anderson

Madrid, Madrid, Spain

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