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

Pfizer

Status and phase: Withdrawn; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Exemestane; Drug: PF-04691502

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658176

B1271005

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

PF-04691502 + Exemestane

Experimental group

Description:

PF-04691502 in combination with Exemestane

Treatment:

Drug: Exemestane

Drug: Exemestane

Drug: PF-04691502

Exemestane

Active Comparator group

Description:

Exemestane alone

Treatment:

Drug: Exemestane

Drug: Exemestane