212
Participants
Start Date
December 17, 2021
Primary Completion Date
September 15, 2026
Study Completion Date
October 15, 2026
Alpelisib
Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.
Fulvestrant
Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle (each cycle is 28 days).
Alpelisib-matching placebo
"Alpelisib-matching placebo (tablets) administered orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.~After Protocol Amendment 5 is implemented, alpelisib matching-placebo will no longer be supplied or administered once participants have been unblinded."
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Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY