EUCTR2007-003466-18-IT进行中（未招募）不适用
PHASE II TRIAL OF PRIMARY CHEMOTHERAPY WITH TRASTUZUMAB IN COMBINATION WITH DOCETAXEL FOLLOWED BY EPIRUBICIN-CYCLOPHOSPHAMIDE IN PATIENTS WITH HER2-OVEREXPRESSING OPERABLE BREAST CANCER - DECT
ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点开始时间: 2007年7月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 proven HER2-positive breast cancer
- •● cT2-T3 N0-N2 breast cancer
- •● ECOG PS status <= 1
- •● Age 18-75 years
- •● Normal cardiac function confirmed by ECG and LVEF
- •● Normal hemathologic, epatic and renal function
- •● Complete staging within 45 days prior to registration, with no evidence of metastatic disease
- •● Patients must be accessible for treatment and follow-up
- •● Negative pregnancy test (urine or serum)
- •● Patient informed consent
- •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
- •Prior systemic therapy for breast cancer
- •Prior radiation therapy for breast cancer
- •Evidence of metastatic or locally advanced disease
- •Pre-existing neuropathy grade >= 2 by NCI criteria
- •Cardiac diseases: previous myocardial infarction or angina pectoris, history of congestive heart failure, grade 3-4 cardiac arrhythmia, clinically significant valvular heart disease, poorly controlled hypertension
- •Psychiatric disorders
- •Active uncontrolled infection
- •Active peptic ulcer, unstable diabetes mellitus
- •Past or current history of other neoplasm except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix
- •Concurrent use of other experimental drugs
- •Male patients
研究者
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