Eligibility criteria
Condition
Breast Neoplasms
Sex
Female
Age
18 + years
Inclusion criteria
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- Inoperable estrogen receptor positive, Her-2 negative advanced breast cancer
- Previously treated with an aromatase inhibitor
- Primary or secondary hormone resistance
- Acceptable glucose control, bone marrow, liver and kidney function
Exclusion criteria
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- Inflammatory breast carcinoma
- Prior therapy with an agent active on PI3K, Akt, and/or mTOR
- Known hypersensitivity to exemestane
- Significant gastrointestinal abnormalities which may impair intake, transit, or
absorption of the study drugs
- Current or anticipated need for food or drugs that are known inhibitors or inducers of
CYP3A4