SummaryThis trial will consist of two parts: a phase Ib section and a phase III section. Eligible patients in the phase Ib section will receive single oral daily doses of Ipatasertib for a run-in period of 5-7 days, and then for Day 1-21 of the first 28-day cycle. Doses will increase to twice per day for Day 1-21 in the second cycle. Palbociclib and Fulvestrant will also be received during the phase Ib part, as per the details below.
During the phase III part eligible patients will receive either Ipatasertib or a placebo to be orally administered once per day on Days 1-21 of each 28 day cycle, at the dose identified in the part Ib phase. Patients will also receive Palbociclib to be orally administered once per day on Days 1-21 of each 28-day cycle and injections of Fulvestrant on Day 1 and 15 of the first cycle and Day 1 for all other cycles.
This trial is treating patients with locally advanced inoperable or metastatic breast cancer.
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A phase Ib/III study of Ipatasertib plus Palbociclib and Fulvestrant versus placebo plus Palbociclib and Fulvestrant in hormone receptor positive and HER2 negative locally advanced unresectable or metastatic breast cancer