New hope for Hard-to-Treat breast cancer: targeted pill combo in final testing

NCT ID NCT05038735

Ongoing Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 4 times

Summary

This phase 3 study tests whether adding alpelisib (a targeted pill) to fulvestrant (a hormone-blocking shot) can slow cancer growth in men and postmenopausal women with HR-positive, HER2-negative advanced breast cancer that has a PIK3CA mutation. Participants must have already tried and progressed on an aromatase inhibitor and a CDK4/6 inhibitor. The main goal is to see how long the cancer stays under control compared to placebo plus fulvestrant.

What this could mean

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

Active substance: alpelisib and fulvestrant
What this could lead to: If successful, this could provide a new treatment option for people with a specific genetic mutation whose breast cancer has stopped responding to standard therapies.
What could go wrong: This is a late-stage trial, but the drug combination may not improve survival or delay cancer growth compared to placebo. Side effects like high blood sugar, rash, and diarrhea are possible.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

BREAST CANCER

Contacts and locations

Locations

Novartis Investigative Site

Sint-Niklaas, Oost Vlaanderen, 9100, Belgium
Novartis Investigative Site

Brussels, 1000, Belgium
Novartis Investigative Site

Brussels, 1200, Belgium
Novartis Investigative Site

Ghent, 9000, Belgium
Novartis Investigative Site

Leuven, 3000, Belgium
Novartis Investigative Site

Liège, 4000, Belgium
Novartis Investigative Site

Plovdiv, 4004, Bulgaria
Novartis Investigative Site

Sofia, 1330, Bulgaria
Novartis Investigative Site

Calgary, Alberta, T2N 5G2, Canada
Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada
Novartis Investigative Site

Brno, 656 53, Czechia
Novartis Investigative Site

Nový Jičín, 741 01, Czechia
Novartis Investigative Site

Prague, 100 34, Czechia
Novartis Investigative Site

Prague, 128 08, Czechia
Novartis Investigative Site

Prague, 140 59, Czechia
Novartis Investigative Site

Aalborg, 9000, Denmark
Novartis Investigative Site

Helsinki, 00029, Finland
Novartis Investigative Site

Tampere, FIN-33521, Finland
Novartis Investigative Site

Besançon, 25030, France
Novartis Investigative Site

Clermont-Ferrand, 63011, France
Novartis Investigative Site

La Roche-sur-Yon, 85925, France
Novartis Investigative Site

Lyon, 69373, France
Novartis Investigative Site

Marseille, 13273, France
Novartis Investigative Site

Montpellier, 34298, France
Novartis Investigative Site

Paris, 75475, France
Novartis Investigative Site

Paris, 75970, France
Novartis Investigative Site

Valenciennes, 59300, France
Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany
Novartis Investigative Site

Augsburg, 86150, Germany
Novartis Investigative Site

Berlin, 13353, Germany
Novartis Investigative Site

Essen, 45136, Germany
Novartis Investigative Site

Lübeck, 23538, Germany
Novartis Investigative Site

Athens, 115 22, Greece
Novartis Investigative Site

Pátrai, 265 04, Greece
Novartis Investigative Site

Budapest, H 1122, Hungary
Novartis Investigative Site

Dublin, DO4, Ireland
Novartis Investigative Site

Bari, BA, 70124, Italy
Novartis Investigative Site

Bergamo, BG, 24127, Italy
Novartis Investigative Site

Bologna, BO, 40138, Italy
Novartis Investigative Site

Florence, FI, 50134, Italy
Novartis Investigative Site

Genova, GE, 16132, Italy
Novartis Investigative Site

Milan, MI, 20132, Italy
Novartis Investigative Site

Milan, MI, 20133, Italy
Novartis Investigative Site

Milan, MI, 20141, Italy
Novartis Investigative Site

Rozzano, MI, 20089, Italy
Novartis Investigative Site

Palermo, PA, 90127, Italy
Novartis Investigative Site

Padova, PD, 35128, Italy
Novartis Investigative Site

Aviano, PN, 33081, Italy
Novartis Investigative Site

Roma, RM, 00168, Italy
Novartis Investigative Site

Terni, TR, 05100, Italy
Novartis Investigative Site

Naples, 80131, Italy
Novartis Investigative Site

Bydgoszcz, 85 796, Poland
Novartis Investigative Site

Coimbra, 3000-075, Portugal
Novartis Investigative Site

Lisbon, 1099-023, Portugal
Novartis Investigative Site

Lisbon, 1400-038, Portugal
Novartis Investigative Site

Porto, 4200-072, Portugal
Novartis Investigative Site

Floreşti, Cluj, 407280, Romania
Novartis Investigative Site

Craiova, Dolj, 200347, Romania
Novartis Investigative Site

Bratislava, 812 50, Slovakia
Novartis Investigative Site

Bratislava, 83310, Slovakia
Novartis Investigative Site

Košice, 041 91, Slovakia
Novartis Investigative Site

Badajoz, Extremadura, 06080, Spain
Novartis Investigative Site

Pozuelo de Alarcón, Madrid, 28223, Spain
Novartis Investigative Site

Oviedo, Principality of Asturias, 33011, Spain
Novartis Investigative Site

A Coruña, 15009, Spain
Novartis Investigative Site

Barcelona, 08036, Spain
Novartis Investigative Site

Madrid, 28040, Spain
Novartis Investigative Site

Málaga, 29011, Spain
Novartis Investigative Site

Zaragoza, 50009, Spain

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