EUCTR2006-006473-24-DE进行中（未招募）不适用
A randomized, open-label, multi-center study of larotaxel at 90mg/m² or docetaxel every 3 weeks, alone or in combination with trastuzumab according to Her2neu status, administered after a combination regimen of anthracycline and cyclophosphamide as pre-operative therapy in patients with high risk localized breast cancer - SATI
sanofi-aventis recherche & developpement0 个研究点目标入组 310 人开始时间: 2007年1月22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
- 入组人数
- 310
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
- •1. For enrollment (before run-in treatment):
- •-Histologically proven invasive breast adenocarcinoma
- •-Localized breast cancer: Stage II and III
- •-Tumors clinically palpable and ineligible for breast conservative surgery:
- •* Unifocal tumor with diameter > or = 3 cm (clinical examination) or
- •* central unifocal tumor,
- •Or whose characteristics make pre-operative chemotherapy mandatory due to high risk factors (i.e. ipsilateral lymph nodes involvement, rapid growth rate).
- •* Known status for Her2neu by immunohistochemistry (IHC) or by fluorescent in situ hybridization (FISH)
- •2. For randomization (at the end of run-in treatment):
- •-Hormonal receptors, cytokeratin 5/6 and /or cytokeratin 17, p53 and Ki67 by IHC
- •-Patients having received at least 3 cycles of anthracycline and cyclophosphamide
- •-Patients with no disease progression.
- •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
- •1. For enrollment (before run-in treatment):
- •- Abnormal LVEF (< 50%)
- •- Prior or current history and study drugs-linked criteria:
- •*Bilateral breast cancer
- •* Multifocal breast tumors
- •*Inflammatory breast cancer
- •*Distant metastases (stage IV)
- •*Loco-regional relapse
- •*Any of the following within 6 months prior to enrollment: myocardial infarction, severe/unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhythmias (grade 3-4)
- •2.For randomization (at the end of run-in treatment):
- •-Abnormal LVEF (< 50%)
研究者
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