Phase II Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 26
- 主要终点
- Number of Participants With Disease Progression (PD) or Death
研究概览
简要总结
The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed hormone receptor positive (HR+) [(estrogen receptor (ER+) and/or progesterone receptors(PgR+)] breast cancer according to immunohistochemistry (IHC)
- •Measureable or evaluable-only disease
- •human epidermal growth factor receptor 2+ (HER2+) or HER2- breast cancer
- •Males and females ≥18 years of age
- •Females are post menopausal or surgically sterile
- •Recurrent or progressive advanced breast cancer (locally-advanced or metastatic), that has progressed: (a) during or within 12 months after completion of adjuvant Aromatase Inhibitor (AI) treatment OR (b) during AI treatment in advanced setting (metastatic therapy)
排除标准
- •Pregnant or breast feeding
- •>1 chemotherapy regimen for advanced disease
- •Pleural or pericardial effusion
- •Serious cardiac condition
研究组 & 干预措施
Arm 1 (Dasatinib +Fulvestrant)
干预措施: Dasatinib (Drug)
Arm 1 (Dasatinib +Fulvestrant)
干预措施: Fulvestrant (Drug)
Arm 2 (Fulvestrant)
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Number of Participants With Disease Progression (PD) or Death
时间窗: Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up.
次要结局
- Percentage of Participants With Clinical Benefit for At Least 6 Months(Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years))
- Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events(Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years))
- Median Time of Progression-free Survival (PFS)(Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years))
- Percentage of Participants With Progression Free Survival (PFS) at 6 Months(at 6 months)
- Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD)(Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years))
- Number of Participants With Best Overall Response(Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years))