Phase II, Open Label, Neoadjuvant Study of Bevacizumab in Patients With Inflammatory or Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 主要终点
- Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
研究概览
简要总结
This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. 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
- Na
- 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 participants, >=18 years of age;
- •stage III, or inflammatory breast cancer;
- •estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
- •normal left ventricular ejection fraction (LVEF).
排除标准
- •previous chemotherapy/endocrine therapy;
- •evidence of distant metastatic disease;
- •other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
- •chronic daily treatment with >325 milligram per day (mg/day) aspirin, or >75mg/day clopidogrel.
研究组 & 干预措施
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
干预措施: 5-fluorouracil (Drug)
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
干预措施: Epidoxorubicin (Drug)
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
干预措施: Cyclophosphamide (Drug)
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
干预措施: Paclitaxel (Drug)
Bevacizumab
Participants will receive FEC, followed by paclitaxel, given concomitantly with bevacizumab for approximately 3-12 months.
干预措施: Bevacizumab (Biological)
结局指标
主要结局
Percentage of Participants With Pathological Complete Response Following Principle Investigator Review
时间窗: Up to 7.5 years
Pathological complete response was defined as absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy.
次要结局
- Percentage of Participants With Disease-Free Interval(Months 12, 24, 36, 48, and 60)
- Objective Response Rate(Up to 7.5 years)
- Percentage of Participants With Breast-Conserving Surgery(Up to 7.5 years)
- Percentage of Participants Experiencing Any Adverse Event(Up to 7.5 years)
- Overall Survival(Up to 7.5 years)