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ACTIVE NOT RECRUITING

NCT05038735

PHASE3

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.

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Official title: EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

234

Start Date

2021-12-17

Completion Date

2027-02-26

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

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.

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).

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.

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

Locations (68)

Novartis Investigative Site

Sint-Niklaas, Oost Vlaanderen, Belgium

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Brussels, Belgium

Novartis Investigative Site

Ghent, Belgium

Novartis Investigative Site

Leuven, Belgium

Novartis Investigative Site

Liège, Belgium

Novartis Investigative Site

Plovdiv, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Ottawa, Ontario, Canada

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Nový Jičín, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Prague, Czechia

Novartis Investigative Site

Aalborg, Denmark

Novartis Investigative Site

Helsinki, Finland

Novartis Investigative Site

Tampere, Finland

Novartis Investigative Site

Besançon, France

Novartis Investigative Site

Clermont-Ferrand, France

Novartis Investigative Site

La Roche-sur-Yon, France

Novartis Investigative Site

Lyon, France

Novartis Investigative Site

Marseille, France

Novartis Investigative Site

Montpellier, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Paris, France

Novartis Investigative Site

Valenciennes, France

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Augsburg, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Essen, Germany

Novartis Investigative Site

Lübeck, Germany

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Pátrai, Greece

Novartis Investigative Site

Budapest, Hungary

Novartis Investigative Site

Dublin, Ireland

Novartis Investigative Site

Bari, BA, Italy

Novartis Investigative Site

Bergamo, BG, Italy

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Florence, FI, Italy

Novartis Investigative Site

Genova, GE, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Rozzano, MI, Italy

Novartis Investigative Site

Palermo, PA, Italy

Novartis Investigative Site

Padova, PD, Italy

Novartis Investigative Site

Aviano, PN, Italy

Novartis Investigative Site

Roma, RM, Italy

Novartis Investigative Site

Terni, TR, Italy

Novartis Investigative Site

Milan, Italy

Novartis Investigative Site

Naples, Italy

Novartis Investigative Site

Bydgoszcz, Poland

Novartis Investigative Site

Coimbra, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Lisbon, Portugal

Novartis Investigative Site

Porto, Portugal

Novartis Investigative Site

Floreşti, Cluj, Romania

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Bratislava, Slovakia

Novartis Investigative Site

Košice, Slovakia

Novartis Investigative Site

Badajoz, Extremadura, Spain

Novartis Investigative Site

Pozuelo de Alarcón, Madrid, Spain

Novartis Investigative Site

Oviedo, Principality of Asturias, Spain

Novartis Investigative Site

A Coruña, Spain

Novartis Investigative Site

Barcelona, Spain

Novartis Investigative Site

Madrid, Spain

Novartis Investigative Site

Málaga, Spain

Novartis Investigative Site

Zaragoza, Spain

Clinical Research Directory

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.

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)