Identification Module
The Identification Module contains basic identifying information about the clinical trial, including the NCT ID, brief title, official title, acronym, organization study ID information, and organization details. This module provides essential identifiers for the trial.
Identification Module path is as follows:
Study -> Protocol Section -> Identification Module
Identification Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT05038735
Brief Title:
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.
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
Acronym:
EPIK-B5
Study:
NCT05038735
Protocol Section:
NCT05038735