NCT00994968Unknown2 期
Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Rate of pathologic complete response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and S-1, 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) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying giving doxorubicin hydrochloride together with cyclophosphamide, docetaxel, and S-1 before surgery in treating women with stage II or stage III breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the rate of pathologic complete response in women with previously untreated stage II or III breast cancer treated with neoadjuvant doxorubicin hydrochloride and cyclophosphamide followed by docetaxel and S1.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
- Determine the rate of overall radiologic response in these patients.
- Determine the rate of breast-conserving procedures in these patients.
- Determine the disease-free survival of these patients.
- Investigate the relevant pharmacogenomics and biomarker(s) which will be useful to predict any responses to the anticancer treatments.
研究设计
- 研究类型
- Interventional
- 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
Rate of pathologic complete response
次要结局
- Safety and tolerability
- Rate of overall radiologic response
- Rate of breast-conserving procedure
- Disease-free survival
- Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Chemotherapy & Bevacizumab for Human Epidermal Growth Factor Receptor 2 (HER2)/Neu-Negative Stage II/III Breast CancerHER2-negative Breast CancerStage II Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerNCT00679029University of Nebraska15
终止
2 期
Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone SarcomaSarcomaNCT00544778City of Hope Medical Center7
已完成
3 期
Neo-Adjuvant Chemotherapy (TAC) With or Without Zoledronic Acid in Treating HER2-negative Breast Cancer PatientsBreast CancerNCT01099436Borstkanker Onderzoek Groep250
已完成
2 期
Epirubicin and Cyclophosphamide Followed By Docetaxel and Trastuzumab in Treating Women With HER2-Positive Stage III or Stage IV Breast CancerBreast CancerNCT00379015Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan38
Unknown
2 期
Cyclophosphamide and Docetaxel or Doxorubicin in Treating Women With Newly Diagnosed Breast Cancer That Can Be Removed by SurgeryBreast CancerNCT00801411National Cancer Centre, Singapore318