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

NCT ID NCT05038735

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 8 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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

210 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Participant is an adult ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. * Participant has a histologically and/or cytologically confirmed diagnosis of ER+ and/or PgR+ breast cancer by local laboratory. * Participant has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (Fluorescent in situ hybridization (FISH), Chromogenic in situ hybridization (CISH), or Silver-enhanced in situ hybridization (SISH)) test is required by local laboratory testing. * Participant has at least one measurable lesion as per RECIST v1.1 criteria as assessed by Investigator (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation). * Participant has recurrence or progression of disease during or after combined AI (i.e. letrozole, anastrozole, exemestane) and CDK4/6 inhibitor therapy. The combined AI and CDK4/6 inhibitor therapy does not need to be the latest treatment regimen (including adjuvant setting). * Participant has received ≤ 2 prior lines of systemic therapies overall in the metastatic setting, of which a maximum of 1 line of prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy) is permitted. * The presence of PIK3CA mutation(s) determined in tumor tissue prior to enrollment either by a Novartis designated laboratory or in tumor tissue or plasma ctDNA by a local laboratory using a Food and Drug Administration (FDA)-approved PIK3CA Companion Diagnostics (CDx) test for alpelisib or the CE-IVD QIAGEN Therascreen® PIK3CA RGQ PCR test. * If female, then the participant must be in postmenopausal status. Key Exclusion Criteria: * Participant with symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy (ET) per the Investigator's best judgment. * Participant who relapsed with documented evidence of progression more than 12 months from completion of (neo)adjuvant endocrine/endocrine-based therapy with no treatment for metastatic disease. * Participant has received prior treatment with fulvestrant, any oral selective estrogen receptor degrader (SERD), any Phosphatidylinositol-3-Kinase (PI3K), mammalian Target of Rapamycin (mTOR) or Protein Kinase B (AKT) inhibitor. Other Inclusion and Exclusion Criteria do apply

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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, 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, 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

    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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