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A Two-Arm Randomized Open Label Phase 2 Study Of CP-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer


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

Thank you

Trial Information

A Two-Arm Randomized Open Label Phase 2 Study Of CP-751,871 In Combination With Exemestane Versus Exemestane Alone As First Line Treatment For Postmenopausal Patients With Hormone Receptor Positive Advanced Breast Cancer


Inclusion Criteria:



- Postmenopausal women with a diagnosis of hormone receptor positive advanced breast
cancer

- HbA1c <5.7%

Exclusion Criteria:

- Previous treatment for advanced disease

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy of the exemestane plus CP-751,871 combination measured as Progression Free Survival

Outcome Time Frame:

60 months

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:

A4021004

NCT ID:

NCT00372996

Start Date:

February 2007

Completion Date:

March 2014

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteWashington, District of Columbia  20007-2197
Pfizer Investigational SiteBurlington, Vermont  05401-3456