Trial Profile

BYLieve:A phase II, multicenter, open-label, three-cohort, noncomparative study to assess the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, hormone receptor (HR) positive, HER2-negative advanced breast cancer (aBC), who have progressed on or after prior treatments

Status: Completed

Phase of Trial: Phase II

Latest Information Update: 21 Jan 2025

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At a glance

Drugs Alpelisib (Primary) ; Fulvestrant; Goserelin; Letrozole; Leuprorelin
Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
Focus Therapeutic Use
Acronyms BYLieve
Sponsors Novartis Healthcare; Novartis Pharma A.G.; Novartis Pharmaceuticals

20 Dec 2024 Status changed from active, no longer recruiting to completed.
18 Oct 2023 This trial has been completed in Spain according to the European Clinical Trials Database record.
08 Sep 2023 This trial has been completed in Denmark, and Netherlands, according to the European Clinical Trials Database record.

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