A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have been diagnosed with metastatic or recurrent breast cancer.
- •Have been previously treated with both an anthracycline and a taxane.
- •Have not received more than two prior chemotherapy treatment programs.
- •Have stopped any antitumoral hormonal treatment before you enroll in this study.
- •Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment.
排除标准
- •Cannot follow the study procedures (for example, you cannot swallow tablets).
- •Are receiving another treatment for your cancer.
- •Have received another experimental drug in the last 4 weeks.
- •Have had serious heart disease within last 6 months.
- •Are pregnant or breast-feeding.
研究组 & 干预措施
Capecitabine + Enzastaurin
干预措施: enzastaurin (Drug)
Capecitabine + Enzastaurin
干预措施: capecitabine (Drug)
Capecitabine + Placebo
干预措施: placebo (Drug)
Capecitabine + Placebo
干预措施: capecitabine (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Randomization to measured progressive disease or death up to 14 months
PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
次要结局
- Pharmacokinetics: Area Under the Concentration Curve Versus Time From Time 0 to Last Quantifiable Value (AUC0-tlast) of Capecitabine(Pre-dose to 6 hours post-dose on Day 1 of Cycle 2)
- Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State(From pre-dose to 24 hours post-dose on Day 1 of Cycle 2)
- Pharmacology Toxicity and Adverse Events (AEs)(Baseline to study completion [Cycle 19 (21 days/cycle) and 30-day safety follow-up])
- Expression of Tumor Markers in Tissue Samples (Tumor Markers and Genes Evaluation)(Randomization, Cycle 2, end of study)
- Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)(Randomization to last visit (up to 9.66 months))
- Duration of Response (DOR)(Randomization to last visit (up to 9.66 months))
- Overall Survival (OS)(Randomization to date of death from any cause up to 20.83 months)
- Pharmacokinetics: Maximum Observed Concentration (Cmax) of Capecitabine(From pre-dose to 6 hours post-dose on Day 1 of Cycle 2)