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

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NCT00372996

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
UCSD Medical Center - La Jolla
La Jolla, California, 92037 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

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

- Previous treatment for advanced disease

NCT00372996
Pfizer
Terminated
Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

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Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
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
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
219
June 2014
September 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous treatment for advanced disease
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Canada,   Italy,   Netherlands,   Sweden,   United Kingdom,   United States
 
 
NCT00372996
A4021004
2006-005573-21 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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