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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01658176

Enrollment

Registered

2012-08-06

Start date

2013-01-31

Completion date

2015-04-30

Last updated

2012-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Estrogen receptor positive, Her-2 negative, advanced breast cancer, Breast Cancer

Brief summary

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.

Interventions

DRUGPF-04691502

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

DRUGExemestane

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival	Baseline up to month 12

Secondary

Measure	Time frame
Duration of tumor response	Baseline up to month 12
Clinical benefit response	Baseline up to month 12
Overall Survival	2 years
Biomarkers related to PI3K/mTOR signal deregulation and markers of cellular proliferation and apoptosis in primary tumor tissue	Baseline
Maximum concentration (Cmax) of single dose of PF-04691502	Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose
Maximum concentration (Cmax) of single dose exemestane	Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose
Objective tumor response using RECIST	Baseline up to month 12
Pharmacodynamic endpoints including serum glucose, insulin, HbA1c, cholesterol and triglycerides	12 months
Heath related quality of life measured by Functional Assessment of Cancer Therapy- Breast	12 months
Area under the plasma concentration versus time curve (AUC) of single dose of PF-04691502	Day 2 Pre-dose, and 1 , 2, 4 and 24 hours post-dose
Area under the plasma concentration versus time curve (AUC) of single dose exemestane	Day 1 pre-dose, and 1, 2, 4 and 24 hours post-dose
Area under the plasma concentration versus time curve (AUC) of PF-04691502 and exemestane when administered in combination	Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25
Maximum concentration (Cmax) of PF-04691502 and exemestane when administered in combination	Day 8 Pre-dose, and 1, 2, 4 and 24 hours post-dose, Weel 5, 9, 13, 17, 21, and 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026