Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 6
研究概览
简要总结
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
详细描述
The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.
Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment.
Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.
Approximately 100 patients will participate at Emory Winship Cancer Institute and Emory Crawford W. Long Hospital and Grady Health System in Atlanta, Georgia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically or cytologically confirmed breast carcinoma.
- •Early stage breast cancer (stage 1, 2, 3).
- •No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
- •18 years of age or older.
- •Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
排除标准
- •Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
- •Major surgery within 28 days of study entry.
- •Evidence of CNS metastases.
- •Final eligibility for a clinical trial is determined by the health professionals conducting the trial.