"An Open Label Study to Assess the Effect of Neoadjuvant Treatment With Docetaxel + Xeloda + Avastin on Pathological Response Rate in Inflammatory or Locally Advanced Breast Cancer"
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 主要终点
- Percentage of Participants Achieving Pathological Complete Response (pCR)
研究概览
简要总结
This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •female patients, >=18 years of age;
- •HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
- •ECOG performance status 0-1.
排除标准
- •metastatic disease (stage IV);
- •previous treatment for breast cancer;
- •evidence of CNS metastasis;
- •current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
- •clinically significant cardiovascular disease.
研究组 & 干预措施
1
干预措施: bevacizumab [Avastin] (Drug)
1
干预措施: Docetaxel (Drug)
1
干预措施: Xeloda (Drug)
结局指标
主要结局
Percentage of Participants Achieving Pathological Complete Response (pCR)
时间窗: At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery. In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist. The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined. pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
次要结局
- Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)(Day 1 of Cycles 1-6)
- Progression-Free Survival(Cycles 1-6)
- Overall Survival(Cycles 1-6)
- Percentage of Participants Undergoing Breast-Conserving Surgery(Following Cycle 6)