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

Outcome

Outcome not reported

Stopped: “Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint.”

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