A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 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 efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic 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
- Double (Participant, Investigator)
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
- •Must have signed an inform consent document
- •Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
- •Have not received any prior chemotherapy for locally recurrent or metastatic disease
- •Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
- •Age 18 years or older at time of informed consent
排除标准
- •Have any clinical evidence of central nervous system (CNS) metastases
- •Have a history of seizure
- •Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
- •Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
- •Have symptomatic peripheral vascular disease
研究组 & 干预措施
Enzastaurin + Bevacizumab + Paclitaxel
Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.
Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).
干预措施: Enzastaurin (Drug)
Enzastaurin + Bevacizumab + Paclitaxel
Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.
Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).
干预措施: Bevacizumab (Drug)
Enzastaurin + Bevacizumab + Paclitaxel
Participants randomized to this arm (Arm A) will receive enzastaurin, paclitaxel and bevacizumab until disease progression.
Prior to randomization, a safety lead-in will be conducted in 6 participants who will be treated according to Arm A for 2 cycles (1 cycle = 28 days). Only after an acceptable safety analysis of the safety lead-in, will other participants be randomized to Phase 2 (either Arm A or Arm B). In Phase 2, participants from the safety lead-in will continue treatment according to Enzastaurin + Bevacizumab + Paclitaxel (Arm A).
干预措施: Paclitaxel (Drug)
Bevacizumab + Paclitaxel + Placebo
Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
干预措施: Bevacizumab (Drug)
Bevacizumab + Paclitaxel + Placebo
Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
干预措施: Paclitaxel (Drug)
Bevacizumab + Paclitaxel + Placebo
Participants randomized to this arm (Arm B) will receive bevacizumab, paclitaxel and placebo until disease progression.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Baseline to measured PD (up to 15 days)
PFS was defined as the time from the date of study enrollment to the first date of objectively determined progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST version 1.0). PD is ≥20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. For participants not known to have died and who did not have PD, PFS was censored at the date of the last progression-free assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. No participant completed a full cycle of therapy and thus no formal analysis was performed.
次要结局
- Overall Response Rate (ORR)(Baseline to measured Progressive disease (up to 15 days))
- Number of Participants With Adverse Events (AEs) or Any Serious AEs (SAEs)(Baseline to study completion (Day 15) plus 30-day safety follow-up)