Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
- Conditions
- Breast Neoplasms
- Interventions
- Registration Number
- NCT00372996
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 219
- Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
- HbA1c <5.7%
- Previous treatment for advanced disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CP-751,871 CP-751,871 + exemestane Treatment until progression or toxicity 1 exemestane CP-751,871 + exemestane Treatment until progression or toxicity 1 Fulvestrant CP-751,871 + exemestane Treatment until progression or toxicity 2 exemestane -
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months 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.
PFS in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 Months Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months Objective responses were defined using RECIST as CR: disappearance of all target and nontarget lesions. PR: at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. Nontarget lesions may persist provided there is no unequivocal progression in these lesions. SD: measurements demonstrating neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease (PD) during the first 6 weeks after the start of treatment taking as reference the smallest sum LD since the treatment started. During this time, nontarget lesions may persist provided there is no unequivocal progression in these lesions.
Maximum Plasma Concentration of CP-751,871 Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871 Minimum Plasma Concentration of CP-751,871 Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871 Area Under the Concentration Time Curve From Time 0 to the Last Time Point With Quantifiable Concentration Predose on Day 1 at Cycles 1, 2, 4, and 5 and 150 days post last dose of CP-751,871 and for salvage therapy, at Day 1 and 150 days post last dose of CP-751,871 Number of Participants With Negative Human Anti-Human Antibodies (HAHAs) Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion Negative human anti-human antibodies were defined as \<6.64
Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR) Predose on Day 1 of Cycle 1 Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway Predose on Day 1 of Cycles 1 and 4 and at end of treatment prior to beginning salvage therapy European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 (QLQ-C30) Scores Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions used 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score equals (=) better level of functioning or greater degree of symptoms.
EORTC QLQ Breast Cancer Module (BR23) Scores Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months EORTC-QLQ-BR23: included functional scales (body image, sexual functioning, sexual enjoyment, and future perspective) and single item symptoms scales (systemic therapy side effects, breast symptoms, arm symptoms, and upset by hair loss). Questions used 4-point Likert scale (1 ‘Not at All’ to 4 ‘Very Much’). Scores averaged and transformed to 0-100 scale. High score for functional scale=high/healthy level of functioning. High score for single item=high level of symptomatology/problems. Change from baseline=Cycle/Day score minus baseline score.
Trial Locations
- Locations (59)
UCSD Medical Center - La Jolla
🇺🇸La Jolla, California, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
UCSD Medical Center - Hillcrest
🇺🇸San Diego, California, United States
Washington Cancer Institute (WCI) at Washington Hospital Center (WHC)
🇺🇸Washington, District of Columbia, United States
Florida Cancer Research Institute
🇺🇸Plantation, Florida, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Lexington Oncology Associates
🇺🇸Lexington, Kentucky, United States
Bluegrass Hematology/Oncology, PSC
🇺🇸Lexington, Kentucky, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Bringham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
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