This Phase III, double-blind, randomised study will assess the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.
Who is it for?
You may be eligible for this study if you meet the below criteria:
Study details
Capivasertib + fulvestrant: Patients will be administered 500 mg (2 injections) of fulvestrant on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Patients will also receive 400 mg (2 tablets) capivasertib given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle.
Placebo + fulvestrant: Patients will be administered 500 mg (2 injections) of fulvestrant on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Patients will also receive 400 mg (2 tablets) placebo given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle
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