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 Jun 27, 2026

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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
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Paris, 75970, France
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Valenciennes, 59300, France
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Cologne, North Rhine-Westphalia, 50937, Germany
Novartis Investigative Site

Augsburg, 86150, Germany
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Berlin, 13353, Germany
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Essen, 45136, Germany
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Lübeck, 23538, Germany
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Athens, 115 22, Greece
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Pátrai, 265 04, Greece
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Budapest, H 1122, Hungary
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Dublin, DO4, Ireland
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Bari, BA, 70124, Italy
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Bergamo, BG, 24127, Italy
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Bologna, BO, 40138, Italy
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Florence, FI, 50134, Italy
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Genova, GE, 16132, Italy
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Milan, MI, 20132, Italy
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Milan, MI, 20133, Italy
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Rozzano, MI, 20089, Italy
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Palermo, PA, 90127, Italy
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Padova, PD, 35128, Italy
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Aviano, PN, 33081, Italy
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Roma, RM, 00168, Italy
Novartis Investigative Site

Terni, TR, 05100, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Bydgoszcz, 85 796, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1099-023, Portugal
Novartis Investigative Site

Lisbon, 1400-038, Portugal
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Porto, 4200-072, Portugal
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Floreşti, Cluj, 407280, Romania
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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