A Randomized Phase III Study Exploring the Efficacy of Capecitabine Given Concomitantly or in Sequence to EC-Doc With or Without Trastuzumab as Neoadjuvant Treatment of Primary Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Pathologic complete response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with monoclonal antibodies before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving monoclonal antibodies after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy is more effective with or without capecitabine and/or trastuzumab in treating breast cancer.
PURPOSE: This randomized phase III trial is studying epirubicin, cyclophosphamide, and docetaxel to compare how well they work with or without capecitabine and/or trastuzumab before surgery in treating women with stage I, stage II, or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Compare the pathologic complete response rates in women with stage I-III primary breast cancer treated with neoadjuvant epirubicin hydrochloride, cyclophosphamide, and docetaxel with versus without capecitabine followed by surgery .
- Compare the pathologic complete response rates in women with HER-2/neu-positive tumors receiving trastuzumab (Herceptin®) simultaneously with neoadjuvant epirubicin hydrochloride, cyclophosphamide, and docetaxel to women with HER-2/neu-negative tumors receiving neoadjuvant chemotherapy only.
Secondary
- Determine the toxicity of these regimens in these patients.
- Determine the disease-free (loco-regional and distant) survival and overall survival of patients treated with these regimens.
- Determine the disease-free (loco-regional and distant) survival and overall survival of patients treated with or without trastuzumab.
- Determine the breast conservation rate in patients treated with these regimens.
- Determine the frequency of the use of sentinel node biopsy for selecting patients for neoadjuvant chemotherapy.
- Compare the frequency of sentinel node biopsies at surgery after neoadjuvant chemotherapy in each arm.
- Determine the pathologic complete response rates to each regimen in the subgroup of patients with locally advanced (T4a-d, N0-3, M0) breast cancer.
- Determine the response rate (complete response, partial response, or no change) at surgery (by imaging methods and by histopathological exam) in patient subgroups according to their response after four treatments with epirubicin hydrochloride and cyclophosphamide.
- Determine the intention for the use of neoadjuvant chemotherapy, in terms of freedom from disease, avoiding mastectomy, improving breast conservation, and gaining information about efficacy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pathologic complete response
次要结局
未报告次要终点