Terminated
PHASE2
INTERVENTIONAL
NCT00372996
Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
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
Interventions
Name:
CP-751,871
Type:
DRUG
Description:
CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
Name:
exemestane
Type:
DRUG
Description:
Exemestane given at 25 mg orally once a day.
Name:
exemestane
Type:
DRUG
Description:
Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
Name:
Fulvestrant
Type:
DRUG
Description:
Used for salvage therapy and administered according to the local label and standard clinical practice.
Primary Outcomes
Measure:
Progression-Free Survival (PFS)
TimeFrame:
Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Description:
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20 percent \[%\] increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by Response Evaluation Criteria in Solid Tumors \[RECIST\]); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% confidence interval (CI) is based on the Brookmeyer and Crowley method.
Measure:
PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
TimeFrame:
Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Description:
PFS was calculated from the time of randomization to either progression of disease, death, or treatment discontinuation because of unsatisfactory therapy results (such as global deterioration of health status). Disease progression was defined as 1 or more of the following: radiographic progression (20% increase in measurable lesions, appearance of new lesions or unequivocal progression of evaluable lesions as defined by RECIST); occurrence of new pleural/pericardial effusions or ascites confirmed by positive cytology; persistent hypercalcemia requiring more than 2 IV treatments with bisphosphonates; intervention for any cancer-related events (radiations, surgery) or new symptoms related to tumor growth requiring participant discontinuation; development of brain metastasis; or death for any cause. Median PFS was estimated from the Kaplan-Meier curve. 95% CI is based on the Brookmeyer and Crowley method.
Trial Information
NCT ID
NCT00372996
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Pfizer
Last Updated
December 15, 2025