Trial Identifiers
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Scientific Title
A Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
Cooperative Group
Canadian Cancer Trials Group
Commercial Sponsor
Hoffmann-La Roche
Summary
This is a randomised, triple-blind study with experimental and placebo comparator arms. Participants in the Experimental Arm will receive Ipatasertib (400mg administered orally daily days 1-21 every 28 days) in combination with Fulvestrant (500mg administered via intramuscular injection on days 1 and 15 in cycle one, and only on day 1 in subsequent cycles). Participants in the Placebo Comparator Arm will receive Fulvestrant (500mg administered via intramuscular injection on days 1 and 15 in cycle one, and only on day 1 in subsequent cycles) in combination with a placebo (administered orally daily days 1-21 every 28 days).