NCT05631795 - Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 9, 2022

Primary Completion Date

June 12, 2025

Study Completion Date

June 12, 2025

Conditions

Advanced Breast Cancer

Interventions

DRUG

Alpelisib

Film coated tablet for oral use. Participants will be treated with 300 mg of alpelisib once daily starting on Cycle 1 Day 1

DRUG

Fulvestrant

Injection for intramuscular administration. Participants will be treated with fulvestrant 500 mg on Cycle 1 Day 1 and Day 15, and Day 1 of every cycle thereafter in a 28-day cycle.

Trial Locations (11)

110029

Novartis Investigative Site, New Delhi

380016

Novartis Investigative Site, Ahmedabad

462001

Novartis Investigative Site, Bhopal

670103

Novartis Investigative Site, Thalassery

700026

Novartis Investigative Site, Kolkata

781016

Novartis Investigative Site, Guwahati

700 017

Novartis Investigative Site, Kolkata

160 012

Novartis Investigative Site, Chandigarh

695 011

Novartis Investigative Site, Kerala

400 012

Novartis Investigative Site, Mumbai