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Clinical trial

A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)

NCT03439046 is registered in ClinicalTrials.gov with Novartis Pharmaceuticals as lead sponsor.

NCT NCT03439046
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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)
Lead sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Overall status
Terminated
Start date
February 2, 2018
Completion date
December 11, 2023
Enrollment
287 (actual)
Sites
41

Conditions

As the registry lists them; a condition with its own page is linked.

breast cancer