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

NCT ID: NCT01658176

Last Updated: 2012-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PF-04691502 + Exemestane

PF-04691502 in combination with Exemestane

Group Type EXPERIMENTAL

PF-04691502

Intervention Type DRUG

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

Exemestane

Intervention Type DRUG

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

Exemestane

Exemestane alone

Group Type ACTIVE_COMPARATOR

Exemestane

Intervention Type DRUG

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

Interventions

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PF-04691502

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

Intervention Type DRUG

Exemestane

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

Intervention Type DRUG

Exemestane

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1271005&StudyName=Study%20Of%20PF-04691502%20%28PI3K/mTOR%20Inhibitor%29%20In%20Combination%20With%20Exemestane%20Compared%20With%20Exemestane%20Alone%20In%20Patients%20with%20Advanced%20Breas

To obtain contact information for a study center near you, click here.

Other Identifiers

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B1271005

Identifier Type: -

Identifier Source: org_study_id