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Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

NCT ID: NCT05038735

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-17

Study Completion Date

2027-03-02

Brief Summary

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The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or postmenopausal women with HR-positive, HER2-negative advanced breast cancer with a PIK3CA mutation who progressed or relapsed on or after treatment with an AI plus a CDK4/6 inhibitor.

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Detailed Description

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This is a Phase III, randomized, double-blind, placebo-controlled, international, multi-center trial. Men and postmenopausal women will be randomized to either alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant. Randomization will follow a 1:1 randomization ratio and be stratified by presence of lung and/or liver metastases (yes vs. no) and setting at last prior CDK4/6 inhibitor therapy (adjuvant vs metastatic).

Study treatment with alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant will be initiated on Cycle 1 Day 1, and will continue until disease progression per RECIST v1.1 as per BIRC assessment, start of new antineoplastic therapy, death, lost to follow-up, or withdrawal of consent. A cycle is defined as 28 days.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Alpelisib plus fulvestrant

Alpelisib 300 mg orally once daily on a continuous dosing schedule, in a 28-day cycle + fulvestrant 500 mg as intramuscular injection on Cycle 1 Day 1 and 15, and on Day 1 on every Cycle thereafter, in a 28 days cycle.

Group Type EXPERIMENTAL

Alpelisib

Intervention Type DRUG

Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

Fulvestrant

Intervention Type DRUG

Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle (each cycle is 28 days).

Alpelisib-matching placebo plus fulvestrant

Alpelisib-matching placebo orally once daily on a continuous dosing schedule, in a 28-day cycle + fulvestrant 500 mg as intramuscular injection on Cycle 1 Day 1 and 15 and on Day 1 on every Cycle thereafter, in a 28 days cycle.

After Protocol Amendment 5 is implemented, alpelisib matching-placebo will no longer be supplied or administered once participants have been unblinded.

Group Type PLACEBO_COMPARATOR

Fulvestrant

Intervention Type DRUG

Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle (each cycle is 28 days).

Alpelisib-matching placebo

Intervention Type DRUG

Alpelisib-matching placebo (tablets) administered orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

After Protocol Amendment 5 is implemented, alpelisib matching-placebo will no longer be supplied or administered once participants have been unblinded.

Interventions

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Alpelisib

Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

Intervention Type DRUG

Fulvestrant

Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle (each cycle is 28 days).

Intervention Type DRUG

Alpelisib-matching placebo

Alpelisib-matching placebo (tablets) administered orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.

After Protocol Amendment 5 is implemented, alpelisib matching-placebo will no longer be supplied or administered once participants have been unblinded.

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Sint-Niklaas, Oost Vlaanderen, Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Brno, , Czechia

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Nový Jičín, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Helsinki, , Finland

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Tampere, , Finland

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Besançon, , France

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Clermont-Ferrand, , France

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La Roche-sur-Yon, , France

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Lyon, , France

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Marseille, , France

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Montpellier, , France

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Paris, , France

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Paris, , France

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Valenciennes, , France

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Cologne, North Rhine-Westphalia, Germany

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Augsburg, , Germany

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Berlin, , Germany

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Essen, , Germany

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Lübeck, , Germany

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Athens, , Greece

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Pátrai, , Greece

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Budapest, , Hungary

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Dublin, , Ireland

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Bari, BA, Italy

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Bergamo, BG, Italy

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Bologna, BO, Italy

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Florence, FI, Italy

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Genova, GE, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Palermo, PA, Italy

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Padua, PD, Italy

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Aviano, PN, Italy

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Roma, RM, Italy

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Terni, TR, Italy

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Napoli, , Italy

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Bydgoszcz, , Poland

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Floreşti, Cluj, Romania

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Novartis Investigative Site

Badajoz, Extremadura, Spain

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Novartis Investigative Site

Pozuelo de Alarcón, Madrid, Spain

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Novartis Investigative Site

Oviedo, Principality of Asturias, Spain

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Novartis Investigative Site

A Coruña, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Novartis Investigative Site

Zaragoza, , Spain

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Countries

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Belgium Bulgaria Canada Czechia Denmark Finland France Germany Greece Hungary Ireland Italy Poland Portugal Romania Slovakia Spain

Other Identifiers

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2023-509133-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CBYL719C2303

Identifier Type: -

Identifier Source: org_study_id

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