A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-Free Survival on second-line treatment
研究概览
简要总结
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is <100.
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
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients, age >/=18 years
- •locally recurrent or metastatic HER2-positive breast cancer
- •disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
- •LVEF >/=55% at baseline
排除标准
- •prior treatment with bevacizumab or capecitabine
- •anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
- •chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
- •clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
- •evidence of spinal cord compression or CNS metastasis
- •history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
研究组 & 干预措施
Single Arm
干预措施: bevacizumab [Avastin] (Drug)
Single Arm
干预措施: capecitabine [Xeloda] (Drug)
Single Arm
干预措施: docetaxel (Drug)
Single Arm
干预措施: trastuzumab [Herceptin] (Drug)
结局指标
主要结局
Progression-Free Survival on second-line treatment
时间窗: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
次要结局
- Safety and tolerability: AEs, laboratory parameters, LVEF(throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks)
- Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival(event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter)