Adjuvant Trastuzumab vs Observation in Locally Advanced Breast Cancer Treated With Neoadjuvant Trastuzumab
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Percentage of pathological responses
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, 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. Giving combination chemotherapy together with trastuzumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether trastuzumab is more effective than observation when given after combination chemotherapy and trastuzumab in treating patients with breast cancer.
PURPOSE: This randomized phase II trial is studying trastuzumab to see how well it works compared with observation when given after combination chemotherapy and trastuzumab in treating patients undergoing surgery for stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the percentage of pathological responses in patients with stage II or III breast cancer treated with neoadjuvant therapy comprising fluorouracil, doxorubicin hydrochloride, and cyclophosphamide followed by trastuzumab (Herceptin®) and paclitaxel.
- To compare the disease-free survival of patients treated with adjuvant therapy comprising trastuzumab versus observation.
Secondary
- To measure the overall survival at 3 years in these patients.
- To measure the cardiac safety profile of these regimens in these patients.
- To measure the percentage of patients that become negative on the fluorescence in situ hybridization (FISH) test at the end of neoadjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed invasive breast cancer by needle biopsy
- •Diagnosed within the past 4 weeks
- •Clinical stage IIB, IIIA, IIIB, or IIIC disease
- •Palpable adenopathies present
- •HER2/neu-positive disease, as evidenced by either of the following:
- •HER2/neu overexpression (3+) by immunohistochemistry (IHC)
- •HER2/neu amplification by fluorescence in situ hybridization (FISH)
- •No metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available)
- •Hormone receptor status:
- •Estrogen receptor and/or progesterone receptor status known
- •PATIENT CHARACTERISTICS:
- •Premenopausal or postmenopausal
- •WHO performance status 0-2
- •Not pregnant or nursing
- •Normal hepatic, renal, and hematological function
- •LVEF ≥ 55% by nuclear medicine study or echocardiogram
- •No prior history of cancer, except carcinoma in situ of the cervix
- •No allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (Herceptin®)
- •PRIOR CONCURRENT THERAPY:
- •No prior cancer therapy
排除标准
- 未提供
结局指标
主要结局
Percentage of pathological responses
Disease-free survival
次要结局
- Overall survival at 3 years
- Cardiac toxicity
- Percentage of patients that become negative on the fluorescence in situ hybridization (FISH) test at the end of neoadjuvant therapy