EUCTR2011-002207-15-IT进行中（未招募）不适用
A prospective study with beta-blockers and ACE-inhibitors in patients operable breast cancer experiencing mild cardiac toxicity during treatment with anthracycline and/or trastuzumab - Cardiorete
FONDAZIONE DEL PIEMONTE PER L'ONCOLOGIA IRCC DI CANDIOLO0 个研究点开始时间: 2012年3月8日最近更新:
适应症
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
- •Women older than 18 years; Women with histological diagnosis of invasive breast cancer completely removed by surgery (any T, any N, M0); Women eligible for adjuvant and/or neoadjuvant treatment with anthracyclines and/or trastuzumab; Patients with HER-2 positive tumors assessed by immunohistochemistry and/or Fluorescent in Situ Hybridization (FISH); Adequate hematopietic, hepatic and renal function; Normal cardiac function with LVEF ³ 55% at the baseline; Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 175
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Recurrent or metastatic disease; HER2 negative tumors; Concomitant cardiologic disease which would place the patient at unusual risk; LVEF < 55% at the baseline; Concurrent conditions that contraindicate cardiologic drugs used in this study; Patients with hypertension or other disease already treated with beta-blockers and/or ACE -inhibitors; Concomitant severe diseases which would place the patient at unusual risk; Patients treated with systemic investigational drugs within the past 4 weeks; Pregnancy or breast-feeding.
研究者
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