Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 8, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

July 31, 2026

Conditions
Advanced Breast Cancer
Interventions
DRUG

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."

DRUG

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).

Trial Locations (15)

464 8681

Novartis Investigative Site, Nagoya

466 8560

Novartis Investigative Site, Nagoya

467-8602

Novartis Investigative Site, Nagoya

277 8577

Novartis Investigative Site, Kashiwa

259-1193

Novartis Investigative Site, Isehara

241-8515

Novartis Investigative Site, Yokohama

980 8574

Novartis Investigative Site, Sendai

540-0006

Novartis Investigative Site, Osaka

541-8567

Novartis Investigative Site, Osaka

565 0871

Novartis Investigative Site, Suita

113-8677

Novartis Investigative Site, Bunkyo Ku

135 8550

Novartis Investigative Site, Koto Ku

152-8902

Novartis Investigative Site, Meguro-ku

860-8556

Novartis Investigative Site, Kumamoto

951-8566

Novartis Investigative Site, Niigata

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY