Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer

An Open-Label Randomized Phase 2 Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Advanced Breast Cancer

PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for the treatment of advanced breast cancer in women whose disease has progressed following tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to hormonal therapy and result in greater clinical benefit than exemestane alone in women with estrogen receptor positive advanced breast cancer.

Inclusion Criteria:

• 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:

• 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