Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
Phase 3
Terminated
NCT03439046
| Condition | Breast Cancer |
|---|
| Phase | Phase 3 |
|---|
| Sponsor | Novartis Pharmaceuticals |
|---|
| Status | Terminated |
|---|
| Enrollment | 287 participants |
|---|
| Interventions | Ribociclib, Letrozole, Alpelisib, Fulvestrant |
|---|
| Start date | Feb 2, 2018 |
|---|
| Completion date | Dec 11, 2023 |
|---|
| Results posted | Jul 10, 2026 |
|---|
Summary
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
Progression-Free Survival (PFS) by Cycle 1 Day 15 Complete Mutational Dynamic Change
Up to approximately 5.7 years · months
| Ribociclib+Letrozole (Core Phase) | 55.82 months |
|---|
| Ribociclib+Letrozole (Core Phase) | 16.53 months |
|---|
| Ribociclib+Letrozole (Core Phase) | 15.67 months |
|---|
| Ribociclib+Letrozole (Core Phase) | 22.44 months |
|---|
| Ribociclib+Letrozole (Core Phase) | 10.22 months |
|---|
| Ribociclib+Letrozole (Core Phase) | 11.07 months |
|---|
Number of Participants With Progression-Free Survival (PFS) Events by Cycle 1 Day 15 Complete Mutational Dynamic Change
Up to approximately 5.7 years · participants
| Ribociclib+Letrozole (Core Phase) | 31 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 13 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 6 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 28 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 6 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 10 participants |
|---|
Number of Participants With Hotspot Mutated Genes by Scheduled Timepoint
Up to approximately 5.7 years · participants
| Ribociclib+Letrozole (Core Phase) | 145 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 152 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 160 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 147 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 50 participants |
|---|
| Ribociclib+Letrozole (Core Phase) | 27 participants |
|---|
Open in BENITIONS
View on ClinicalTrials.gov
All trials
This page summarises publicly available data from ClinicalTrials.gov. It is not medical advice and not investment advice. Always consult a qualified healthcare professional.