Stopped: Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint.
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and, in patients with a PIK3CA mutation, on second-line treatment with alpelisib plus fulvestrant
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Progression-Free Survival (PFS) by Cycle 1 Day 15 Complete Mutational Dynamic Change
Timeframe: Up to approximately 5.7 years
Number of Participants With Progression-Free Survival (PFS) Events by Cycle 1 Day 15 Complete Mutational Dynamic Change
Timeframe: Up to approximately 5.7 years
Number of Participants With Hotspot Mutated Genes by Scheduled Timepoint
Timeframe: Up to approximately 5.7 years
Percent Change From Screening in Target Mutation Variant Allele Frequency (VAF)
Timeframe: Up to approximately 5.7 years
Number of Participants With Partial Response (PR) in the Extension Phase
Timeframe: Up to approximately 1.6 years