To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
219
CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle.
Exemestane given at 25 mg orally once a day.
Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity
Progression-Free Survival (PFS)
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.
Time frame: 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 in Participants With Hemoglobin A1c (HbA1c) Less Than (<) 5.7% at Baseline
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.
Time frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
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Used for salvage therapy and administered according to the local label and standard clinical practice.
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 D.C., District of Columbia, United States
Florida Cancer Research Institute
Davie, Florida, 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
...and 52 more locations
Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) Maintained for at Least 6 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.
Time frame: Baseline, Day 1 of Cycles 2 and 4 and then Day 1 of every 3rd cycle starting at Cycle 7 up to 60 months
Maximum Plasma Concentration of CP-751,871
Time frame: 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
Time frame: 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
Time frame: 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)
Negative human anti-human antibodies were defined as \<6.64
Time frame: Predose on Day 1 of Cycle 1 and at 150 days post last CP-751,871 infusion
Percentage of Participants With Circulating Tumor Cells Expressing Insulin-Like Growth Factor 1 Receptor (IGF-IR)
Time frame: Predose on Day 1 of Cycle 1
Percentage of Participants With Serum Markers Relevant to the IGF-1R Pathway
Time frame: 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
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.
Time frame: Predose on Day 1 of each cycle, at the end of treatment and at follow-up, up to 60 months
EORTC QLQ Breast Cancer Module (BR23) Scores
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.
Time frame: Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months