24
Participants
Start Date
January 8, 2021
Primary Completion Date
June 30, 2026
Study Completion Date
July 31, 2026
Alpelisib
"\[Part 1\] Alpelisib administered at 200 mg (DL 1), 250 mg (DL 2) or 300mg (DL 3) orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.~If DL 1 is tolerated, the alpelisib doses of 250 mg will be investigated. If DL 2 is tolerated, the alpelisib doses of 300 mg will be investigated.~\[Part 2\] In the Part 2, participants will be enrolled into Cohort 2 (CDK4/6 inhibitor naive) and Cohort 3 (CDK4/6 inhibitor pre-treated) in parallel and alpelisib will be administered at the recommended dose identified in Part 1."
Fulvestrant
Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days).
Novartis Investigative Site, Nagoya
Novartis Investigative Site, Nagoya
Novartis Investigative Site, Nagoya
Novartis Investigative Site, Kashiwa
Novartis Investigative Site, Isehara
Novartis Investigative Site, Yokohama
Novartis Investigative Site, Sendai
Novartis Investigative Site, Osaka
Novartis Investigative Site, Osaka
Novartis Investigative Site, Suita
Novartis Investigative Site, Bunkyo Ku
Novartis Investigative Site, Koto Ku
Novartis Investigative Site, Meguro-ku
Novartis Investigative Site, Kumamoto
Novartis Investigative Site, Niigata
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY