EUCTR2008-006381-29-DE进行中（未招募）1 期
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 - EXPRESSIO
niversitätsmedizin Mainz0 个研究点目标入组 200 人开始时间: 2009年6月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- histologically confirmed breast carcinoma (including determination of estrogen and progesteron receptor status, grading, her-2/neu-state)
- •- phase cT2, cT3, or cT4 including inflammatory breast carcinoma
- •- nodal negative or positive patients
- •- no evidence for distant metastasis after complete staging including chest X-ray, abdominal sonography, and bone scan within 4 weeks prior to randomisation
- •- no prior surgical, cytostatical, or hormonal therapy (excluding hormonal substitution or contraception), no prior radiation or immunotherapy
- •- primary tumor which is clinical and/or measurable in 2 dimensions by an imaging analysis (obligatory is bilateral mamogram and breast sonography, fakultativ is MRI)
- •- adequate reserve of bone marrow: neutrophils = 1.5 x 10*9/L, platelets = 100 x 10*9/L, hemoglobin = 100 g/L
- •- adequate hepatic and renal function; ASAT (SGOT) and ALAT (SGPT) < 2,5 x ULN, bilirubin and creatinine in normal range (if creatinine is out of normal range creatinine clearance has to be > 60 ml/minute)
- •- normal cardiologic state according to age, estimated by ECG and echocardiography within 4 weeks before start of treatment
- •- ECOG performance state 0-2
- •- age 18 to 70 years
- •- negative pregnancy test (urine or serum) within 7 days prior to registration for woman of childbearing potential
- •- patients have to be available for treatment and follow up examinations. Treatment of a patient who has been randomised to study has to take place at a participating site (site of PI or sub-investigator). The participating site is also incumbent on documentation of follow up examinations.
- •- signed, written informed consent (approved by the Ethics Committee) obtained prior to registration - including patient´s adopted acceptance of therapy and follow up visits
- •- signed, written informed consent of patient for gene expression analysis and the related examinations
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- pregnant or lactating woman; patients with childbearing potential have to use an effective mechanic form of contraception
- •- current motoric or sensoric neuropathy = grade 2 (according to NCI criteria)
- •- pre-existing cardiac diseases which do not admit participating on the study (f. e. LVEF < 50% or unstable Angina Pectoris, history of myocard infarction within one year of randomisation, uncontrolled hypertension > 165/90 mm Hg, high risk, uncontrolled arrhytmia)
- •- history of significant neurological or psychiatric disease (including psychotic disease, dementia and attacks), which could affect understanding of study or agreement on study.
- •- current uncontrolled infection
- •- current gastric ulcer, unstable diabetes mellitus
- •- history of other malignancy except for carcinoma in situ of the cervix or basal cell carcinoma or an other tumor with a disease-free interval of > 12 months after treatment
- •- current daily chronic treatment with corticosteroids (dose of > 20 mg methylprednisolone equivalent), which started within 6 months prior to randomisation
- •- contraindication to treatment with corticosteroids
- •- current treatment with other experimental medication or participation on an other clinical trial with investigative substances within 30 days prior to registration
- •- any other current anticancer therapy
- •- current therapy with sex hormones (treatment has to be discontinued before registration)
- •- male patient
研究者
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