A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and carboplatin works in treating women with operable Stage II or stage III breast cancer.
详细描述
OBJECTIVES:
- To determine the rate of pathological complete response in women with operable triple-negative breast cancer treated with neoadjuvant bevacizumab, docetaxel, and carboplatin.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV, docetaxel IV, and carboplatin IV on day 1. Treatment repeat every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive docetaxel IV and carboplatin IV only during course 6. Patients undergo surgery between weeks 19-21 as planned.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive breast cancer
- •Stage II or III disease
- •No evidence of metastasis (M0)
- •No inflammatory breast cancer (T4d)
- •Must have a primary tumor
- •Operable disease
- •Triple-negative disease, meeting the following criteria:
- •Estrogen receptor-, progesterone receptor-, and HER2-negative by immunohistochemistry (IHC) 0 or 1+ OR fluorescence in situ hybridization negative (in case IHC is 2+)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •Pre- or post-menopausal
- •Not pregnant
- •Absolute granulocyte count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥10 g/dL
- •Serum creatinine ≤ 1.5 mg/dL
- •Total bilirubin ≤ 1.5 mg/dL
- •AST/ALT ≤ 2 times normal
- •Alkaline phosphatase ≤ 2 times normal
- •Normal or nonspecific EKG
- •LVEF ≥ 50% by MUGA or echocardiogram
- •Normal mental function to understand and sign the written informed consent
- •No history of uncompensated congestive heart failure
- •No history of cancer except for carcinoma in situ of the uterine cervix or nonmelanoma skin cancer
- •No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- •No uncontrolled hypertension (systolic BP > 150 mm Hg and/or diastolic BP > 100 mm Hg)
- •No history or evidence of clinically significant cardiovascular disease, including any of the following:
- •Cerebrovascular accident (CVA) or stroke within the past 6 months
- •Myocardial infarction (MI) within the past 6 months
- •Unstable angina
- •NYHA class II-IV congestive heart failure
- •Serious cardiac arrhythmia requiring medication
- •No serious nonhealing wound, peptic ulcer, or bone fracture
- •No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •No known hypersensitivity to any of the study drugs
- •PRIOR CONCURRENT THERAPY:
- •No prior hormone therapy, chemotherapy, or radiotherapy for breast cancer
- •No prior breast surgery other than biopsy to confirm diagnosis
- •No concurrent chronic daily corticosteroids (more than 10 mg/day methylprednisolone equivalent)
排除标准
- 未提供
结局指标
主要结局
pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment
时间窗: After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery
Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery
次要结局
未报告次要终点
研究者
Joohyuk Sohn
Professor
Severance Hospital