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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 219
- 试验地点
- 59
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
- •HbA1c <5.7%
排除标准
- •Previous treatment for advanced disease
研究组 & 干预措施
1
CP-751,871 + exemestane Treatment until progression or toxicity
干预措施: CP-751,871 (Drug)
1
CP-751,871 + exemestane Treatment until progression or toxicity
干预措施: exemestane (Drug)
1
CP-751,871 + exemestane Treatment until progression or toxicity
干预措施: Fulvestrant (Drug)
2
干预措施: exemestane (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)
- 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 Breast Cancer Module (BR23) Scores(Predose on Day 1, at end of treatment, and at Follow-up, up to 60 months)