A Phase 2 Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Hormone Receptor-Positive Breast Cancer Subjects With Acquired Resistance to Non-Steroidal Aromatase Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 77
- 试验地点
- 16
- 主要终点
- Progression Free Survival Rate at 24 Weeks
研究概览
简要总结
The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
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 hormone receptor-positive and HER-2 negative breast cancer
- •Disease progression following non-steroidal aromatase inhibitor treatment
排除标准
- •Known symptomatic brain metastasis
- •Medical condition requiring chronic steroids
- •History of Type 1 or 2 Diabetes
- •Uncontrolled or significant cardiovascular (CV) disease
- •Concomitant second malignancies
研究组 & 干预措施
BMS-754807
干预措施: BMS-754807 (Drug)
BMS-754807 + letrozole
干预措施: BMS-754807 (Drug)
BMS-754807 + letrozole
干预措施: letrozole (Drug)
结局指标
主要结局
Progression Free Survival Rate at 24 Weeks
时间窗: 24 weeks after initiation of study treatment
Progression free survival (PFS) rate at 24 weeks after treatment with BMS 754807/letrozole was to be calculated as the total number of subjects neither progressed nor died after 24 weeks of treatment divided by the total number of subjects (with measurable or non-measurable disease) randomized/assigned to combination treatment arm and treated. In participants with measurable disease Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) criteria was to be used to assess disease progression.This outcome was not measured due to early termination of the study.
次要结局
- The Objective Response Rate (ORR) in Participants With Measurable Disease(24 weeks after initiation of study treatment)
- Number of Participants With Adverse Events (AEs), Serious AEs, Non-serious AEs , Discontinuation Due to AEs and Deaths(Non-SAEs: Day 1 to 7 days after the participant discontinues study medication or 7 days after the End of Treatment visit (up to 42 months), For SAEs: during the screening period and within 30 days of discontinuation of dosing ,up to 42 months)
- Changes in Absolute Copy Numbers and Relative Expression of Insulin Receptor Isoform A (IR-A) in Tumor Tissue in Response to Treatment(24 weeks after initiation of study)
- Duration of Response (DOR) in Participants With Measurable Disease(24 weeks after initiation of study treatment)
- Treatment Failure Rate (TFR)(24 weeks after initiation of study treatment)
- Number of On-study Laboratory Abnormalities: Grade 1-2(Assessed from day 1 up to within 30 days of last dose (Approximately 42 months))
- Number of On-study Laboratory Abnormalities: Grade 3-4(Assessed from day 1 up to within 30 days of last dose (Approximately 42 months))