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Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

This study has been terminated.
(This study was closed to enrollment as of 13 May 2011 due to business reasons. Premature closure was not prompted by any safety or efficacy concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00372996
First received: September 5, 2006
Last updated: May 31, 2013
Last verified: May 2013
History of Changes
  Purpose

To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer


Condition Intervention Phase
Breast Neoplasms
 Drug: CP-751,871
Drug: exemestane
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Exemestane
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Efficacy of the exemestane plus CP-751,871 combination measured as Progression Free Survival [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Clinical benefit [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • PK [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • Pharmacodynamics and Quality of Life Outcome [ Time Frame: 60 months ] [ Designated as safety issue: No ]

Enrollment: 213
Study Start Date: February 2007
Estimated Study Completion Date: March 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
CP-751,871 + exemestane Treatment until progression or toxicity
 Drug: CP-751,871
CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
Drug: exemestane
Exemestane given at 25 mg orally once a day.
Active Comparator: 2 Drug: exemestane
Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
  • HbA1c <5.7%

Exclusion Criteria:

  • Previous treatment for advanced disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372996

  Show 36 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00372996     History of Changes
Other Study ID Numbers: A4021004
Study First Received: September 5, 2006
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Exemestane
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013