JPRN-UMIN000001076已完成未知
Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer - Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
Kinki Multidisciplinary Breast Oncology Group0 个研究点目标入组 35 人开始时间: 2008年3月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 70years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Histologically proven female breast cancer who underwent complete surgical excision No incidence of axillary metastasis by lymph node dissection or sentinel node biopsy Age >= 20 to =<34 or >=35 to =<70 who fills one of the followings (St.Gallen category of node-negative with intermediate risk) Tumor size >2cm Histologic and / or nuclear grade2-3 Presence of peritumoral vascular invasion HER2 IHC (3+) or FISH (+) ER (-) ECOG PS 0-1 No more than 2 weeks from the lastsurgery Patients were required to have leukocyte >= 4000/mm3 or neutrophil >= 2000/mm3 hemoglobin >= 10 g/dL platelet count >= 100,000/ mm3 total bilirubin =< 1.5 mg/dL AST =< 2.5x the upper limit of normal serum creatinine less than 1.5 mg/dL Sufficient organ function Written informed consent
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eoadjuvant, sequential chemotherapy with docetaxel followed by Fluorouracil, Epirubicin, and Cyclophosphamid every 3 weeks - genome wide expression analysis for identification of a predictive gene signature in patients with primary breast cancer - EXPRESSIOEligible will be only females between 18 - 70 years of age, suffering from histologically confirmed primary breast cancer, nodal status positive or negative, phase cT2, cT3, or cT4 including inflammatory disease. Metastatic disease is excluded. All patients will be treated with 3 cycles Docetaxel and 3 cycles FEC.MedDRA version: 14.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10021974Term: Inflammatory breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006202Term: Breast cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-006381-29-DEniversitätsmedizin Mainz200
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