NCT04208178 - Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 16, 2020

Primary Completion Date

June 16, 2026

Study Completion Date

June 16, 2026

Conditions

Advanced HER2+Breast Cancer

Interventions

DRUG

Alpelisib

Alpelisib orally taken - continuous once daily, in a 21-day cycle.

DRUG

Alpelisib matching Placebo

Alpelisib matching placebo orally taken - continuous once daily, in a 21-day cycle

DRUG

Trastuzumab

Trastuzumab 6mg/kg given intravenously - Day 1 of Cycle 1, and on Day 1 of every cycle thereafter (Cycle=21 days)

DRUG

Pertuzumab

Pertuzumab 420 mg given intravenously - Day 1 of Cycle 1, and on Day 1 of every cycle thereafter (Cycle=21 days)

Trial Locations (11)

Novartis Investigative Site, Leuven

Novartis Investigative Site, Liège

Novartis Investigative Site, Saint-Herblain

Novartis Investigative Site, Florence

Novartis Investigative Site, Kuala Lumpur

Highlands Oncology Group, Fayetteville

University of California LA, Los Angeles

Novartis Investigative Site, Saint-Cloud

Novartis Investigative Site, Changchun

Novartis Investigative Site, Shanghai

Novartis Investigative Site, L'Hospitalet de Llobregat