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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-Free Survival

Outcome Time Frame:

Baseline up to month 12

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

B1271005

NCT ID:

NCT01658176

Start Date:

January 2013

Completion Date:

April 2015

Related Keywords:

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

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