Phase II Study of Dasatinib (BMS-354825) for Advanced Estrogen/Progesterone Receptor-Positive or Her2/Neu-Positive Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 8
- 主要终点
- Number of Participants With Objective Response
研究概览
简要总结
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •females, 18 or older
- •recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
- •paraffin-embedded tissue block must be available
- •measurable disease
- •prior chemotherapy with an anthracycline and/or a taxane (neoadjuvant, adjuvant, or metastatic setting)
- •0, 1 or 2 chemotherapies in the metastatic setting
- •adequate organ function
排除标准
- •Metastatic disease confined to bone only
- •Symptomatic central nervous system (CNS) metastasis
- •Concurrent medical condition which may increase the risk of toxicity
- •Unable to take oral medication
研究组 & 干预措施
Dasatinib
Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).
干预措施: Dasatinib (Drug)
Dasatinib
Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).
干预措施: Dasatinib 100 mg (Drug)
结局指标
主要结局
Number of Participants With Objective Response
时间窗: From day of first treatment through Week 25 or at time of discontinuation from study treatment.
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.
Percentage of Participants With Objective Response
时间窗: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
Best Overall Response
时间窗: From day of first treatment through Week 25 or at time of discontinuation from study treatment
Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.
次要结局
- Number of Response-evaluable Participants With Disease Control (DCR)(From day of first treatment through Week 25 or at time of discontinuation from study treatment.)
- Percentage of Response-evaluable Participants With Disease Control (DCR)(From day of first treatment through Week 25 or at time of discontinuation from study treatment.)
- Number of Participants Who Progressed(From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45))
- Median Progression Free Survival (PFS)(From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45))
- Percentage of Participants With Progression-free Survival (PFS) at Weeks 9, 17, and 25(At Weeks 9, 17, and 25)
- Duration Of Objective Response(the time (in weeks) between the first date that criteria for PR were met and the first date that PD or cPD was observed)
- Number of Participants With Death, Adverse Events (AEs), and AEs Leading to Discontinuation(Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug)
- Number of Participants With On-study CTCAE Version 3.0 Grade 3-4 Laboratory Abnormalities(Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug)
- Number of Participants With Serious AEs (SAEs), Drug-related AEs, Drug-related SAEs, and Drug-Related Grade 3 AEs(Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug)
- Number Of Participants With Notable Drug-related AEs(Continuous assessment beginning at initiation of study drug until 30 days after the last dose of study drug)
- Pharmacokinetics (PK): Plasma Concentration of Dasatinib at Week 3(PK assessment was performed at Week 3 visit (Day 15 ±4 days). Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).)
- PK: Plasma Concentration of Dasatinib at Week 7 or Week 9(PK assessment was performed at Week 7 or 9 visit. Blood samples were obtained at Time = 0 hours, and at 1, 3 and 6 hours after each dose, and a trough sample was obtained immediately prior to any dose (~12 hours).)
- Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 3 in Participants With and Without DCR(At Baseline and Week 3 of treatment (Day 15 ±4 days))
- Pharmacodynamics: Percent Change From Baseline In Plasma Level of Collagen Type IV at Week 5 in Participants With and Without DCR(Week 5)
- Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 3 in Participants With and Without DCR(At Baseline and Week 3 of treatment (Day 15 ±4 days))
- Pharmacodynamics: Percent Change From Baseline In Plasma Level of VEGFR2 at Week 5 in Participants With and Without DCR(At Baseline and Week 5 of treatment)