drugset
drugset / Trial / NCT03439046

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

NCT03439046 ↗

Phase 3 Terminated 287 enrolled Novartis Pharmaceuticals
NaSequentialOpen-labelTreatment

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

Timeline

Start
2018-02-02
Primary completion
2023-12-11
Completion
2023-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 300 mg Oral
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Ribociclib Small molecule 600 mg Oral

Indications

breast cancer