A Randomized, Double-Blind, Phase 2 Study of Ruxolitinib or Placebo in Combination With Capecitabine in Subjects With Advanced or Metastatic HER2-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 149
- 主要终点
- Median Survival
研究概览
简要总结
This was a randomized, double-blind, placebo-controlled phase 2 clinical trial comparing the overall survival of women with advanced or metastatic HER2-negative breast cancer who received treatment with capecitabine in combination with ruxolitinib versus those who received treatment with capecitabine 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
- Double (Participant, Investigator)
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
- •Histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast
- •Locally advanced (Stage 3B) or metastatic (Stage 4) disease
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •Received up to 2 prior chemotherapy regimens (not including neoadjuvant/adjuvant therapy) for advanced or metastatic disease
- •Participants with hormone-receptor positive tumors must have failed available lines of hormonal therapy unless hormone therapy was not tolerated or not clinically appropriate
- •≥ 2 weeks elapsed from the completion of previous treatment regimen and must have recovered or be at a new stable baseline from any related toxicities
- •Radiographically measurable or evaluable disease
- •An mGPS of 1 or 2 as defined below:
- •Criteria:
- •modified Glasgow prognostic score (mGPS) of 1: CRP > 10 mg/L and albumin ≥ 35 g/L
- •mGPS of 2: C-reactive protein (CRP) > 10 mg/L and albumin < 35 g/L
排除标准
- •Received prior treatment with capecitabine or fluoropyrimidine for advanced or metastatic disease
- •Received more than 2 prior regimens for advanced or metastatic disease (not including hormonal therapy in the metastatic setting or neoadjuvant or adjuvant therapies)
- •Unknown hormone-receptor status
- •Ongoing radiation therapy or radiation therapy administered within 2 weeks of enrollment
- •Concurrent anticancer therapy
- •Inadequate renal, hepatic or bone marrow function
- •Another current or previous malignancy within 2 years of study entry unless approved by the sponsor
研究组 & 干预措施
Treatment A - Capecitabine and ruxolitinib
干预措施: Ruxolitinib (Drug)
Treatment A - Capecitabine and ruxolitinib
干预措施: Capecitabine (Drug)
Treatment B - Capecitabine and placebo
干预措施: Capecitabine (Drug)
Treatment B - Capecitabine and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Median Survival
时间窗: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
Overall Survival (OS)
时间窗: Randomization until death due to any cause up to 19 months or the data cutoff 08FEB2016.
Overall survival is reported here by the number of days from randomization to death until the data cutoff for the final analysis. The hazard ratio (80% CI) for ruxolitinib versus placebo was estimated using a Cox regression model stratified by hormone-receptor status.
Percentage of Participants Achieving Overall Survival
时间窗: Randomization until death due to any cause at month 3, 6, 9, 12 and 15 or the data cutoff 08FEB2016.
Overall survival was assessed by the time to death or censoring up until 08Feb2016. Participants with no observed death were treated as right-censored at their last date known to be alive. The survival time was analyzed using the Kaplan-Meier method.
次要结局
- Percentage of Participants Achieving Clinical Benefit Rate(Randomization through end of study up to 19 months or the data cutoff 08FEB2016.)
- Progression-free Survival (PFS)(Randomization to disease progression, or death due to any cause if sooner up to 19 months or the data cutoff 08FEB2016.)
- Percentage of Participants Achieving Objective Response Rate(Randomization through end of study up to 19 months or the data cutoff 08FEB2016.)
- Duration of Response (DOR)(Randomization through end of study up to 19 months or the data cutoff 08FEB2016.)