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

Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Breast Neoplasms

Interventions

PF-04691502DRUG

PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule

ExemestaneDRUG

Exemestane administered orally at 25 mg as a continuous daily dosing schedule

ExemestaneDRUG

Exemestane administered orally at 25 mg as a continuous daily dosing schedule

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Progression-Free Survival

Time frame: Baseline up to month 12

Secondary Outcomes

Objective tumor response using RECIST

Time frame: Baseline up to month 12

Duration of tumor response

Time frame: Baseline up to month 12

Clinical benefit response

Time frame: Baseline up to month 12

Overall Survival

Time frame: 2 years

Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue

Time frame: Baseline

Maximum concentration (Cmax) of single dose of PF-04691502

Time frame: Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose

Maximum concentration (Cmax) of single dose exemestane

Time frame: Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose

Maximum concentration (Cmax) of PF-04691502 and exemestane when administered in combination

Time frame: Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25

Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides

Time frame: 12 months

Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast

Data from ClinicalTrials.gov

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