This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.
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Number of participants with dose limiting toxicities
Timeframe: up to 28 days
Objective response rate observed in patients in the dose expansion portion
Timeframe: 16 weeks
Objective response rate observed in patients in the dose expansion portion
Timeframe: 16 weeks