* EPIK-B5
Research type
Research Study
Full title
EPIK-B5: A Phase III, randomized, double-blind, placebo-controlled study of alpelisib (BYL719) 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
IRAS ID
304257
Contact name
Peter Schmid
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-001966-39
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
A study to assess the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in men or post menopausal women with HR positive, HER2-negative advanced breast cancer with a PIK3CA mutation who have progressed or relapsed on or after treatment with AI and a CDK4/6 inhibitor.
°For eligibility into the study, participants must have a PIK3CA mutation at a central lab and will be asked to consent to this screening by completing a Molecular Screening patient information and consent form; or if a local laboratory has confirmed PIK3CA mutation using CE-IVD QIAGEN therascreen PIK3CA RGQ PCR the patient can continue directly into the screening of the study.
°Screening phase begins upon the signature of Main Patient Information Consent Form to participate in the study. This is where the screening activities and assessment to of inclusion and exclusion criteria will be completed.
°If the patient meets the inclusion criteria for study entry the double -blind treatment period begins.Approximately 234 participants will be randomized to either alpelisib plus fulvestrant or alpelisib-matching placebo plus fulvestrant. Randomisation will follow 1:1 ratio and be stratified by presence of lung and/or liver metastases 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 imitated on Cycle 1 Day 1 and will continue until disease progression as per RECIST V1.1 as per BIRC assessment.
°Cross-Over phase - patients randomized to the alpelisib-matching place plus fulvestrant arm who have disease progression per RECIST v1.1 as assessed by BIRC will have the option to crossover to be treated with alpelisib plus fulvestrant.
°Unblinding a single participant at a site will be permitted after disease progression confirmed by BIRC to determine eligibility if the patient will be suitable for crossover and treated with alpelisib plus fulvestrant.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
22/WM/0186
Date of REC Opinion
28 Oct 2021
REC opinion
Favourable Opinion