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

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NCT00372996

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Study Location
UCSD Medical Center - La Jolla
La Jolla, California, 92037, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- HbA1c <5.7%

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous treatment for advanced disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
Official Title  ICMJE 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
Brief Summary To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • 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.
  • Drug: exemestane
    Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
  • Drug: Fulvestrant
    Used for salvage therapy and administered according to the local label and standard clinical practice.
Study Arms  ICMJE
  • Experimental: 1
    CP-751,871 + exemestane Treatment until progression or toxicity
    Interventions:
    • Drug: CP-751,871
    • Drug: exemestane
    • Drug: Fulvestrant
  • Active Comparator: 2
    Intervention: Drug: exemestane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 25, 2014)		219
Original Enrollment  ICMJE
 (submitted: September 6, 2006)		150
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment for advanced disease
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Brazil,   Canada,   Italy,   Netherlands,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372996
Other Study ID Numbers  ICMJE A4021004
2006-005573-21 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP