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. (NCT05038735)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Novartis Investigative Site — Sint-Niklaas, Oost Vlaanderen
Age range: 18 Years to 100 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (69 Sites)
Showing the first 25 of 69 sites.
- Novartis Investigative Site — Sint-Niklaas, Oost Vlaanderen
- Novartis Investigative Site — Brussels,
- Novartis Investigative Site — Brussels,
- Novartis Investigative Site — Ghent,
- Novartis Investigative Site — Leuven,
- Novartis Investigative Site — Liège,
- Novartis Investigative Site — Plovdiv,
- Novartis Investigative Site — Sofia,
- Novartis Investigative Site — Calgary, Alberta
- Novartis Investigative Site — Ottawa, Ontario
- Novartis Investigative Site — Brno,
- Novartis Investigative Site — Nový Jičín,
- Novartis Investigative Site — Prague,
- Novartis Investigative Site — Prague,
- Novartis Investigative Site — Prague,
- Novartis Investigative Site — Aalborg,
- Novartis Investigative Site — Helsinki,
- Novartis Investigative Site — Tampere,
- Novartis Investigative Site — Besançon,
- Novartis Investigative Site — Clermont-Ferrand,
- Novartis Investigative Site — La Roche-sur-Yon,
- Novartis Investigative Site — Lyon,
- Novartis Investigative Site — Marseille,
- Novartis Investigative Site — Montpellier,
- Novartis Investigative Site — Paris,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
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- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.