NCT00600249已完成2 期
Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study.
Centre Jean Perrin12 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 12
- 主要终点
- Pathological complete response assessment of Taxotere-Erbitux combination
研究概览
简要总结
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •§ Age > or equal to 18 years.§
- •Performance status inferior or equal to 1 (WHO criteria)
- •Histologically proven breast cancer, non metastatic, with clinical tumor diameter > or equal to 2 cm.
- •HR negative and HER 2 negative.
- •Clinical stage II and IIIa.
- •Non prior treated patients either by surgery, radiotherapy, hormonotherapy or chemotherapy.§
- •Adequate hematological, renal and hepatic functions : neutrophils > 2.109 /L, platelets > 100.109 /L, Hb > 10 g/dL, normal bilirubin, ASAT and ALAT inferior or equal to 2,5 ULN (upper normal limit), alkaline phosphatases £ 2,5 ULN, creatinine < 140 µmol/L or creatinine clearance > 60 mL/min.§
- •Written informed consent§
- •Affiliation with social security system (or profit being of such a mode) according to terms' of the law of August 9, 2004.
排除标准
- •Male patient.
- •Pregnant or lactating women or childbearing potential with no efficacy contraception.
- •Other breast cancer form and particularly inflammatory form and/or negliged (T4b or T4d).§
- •Non measurable tumor.
- •Prior surgery or primary axillary dissection.
- •Prior treatment for this new breast cancer.
- •Under guardianship patient
- •Patient with antecedent of second cancer, excepted in situ uterine carcinoma or baso-cellular cutaneous cancer considered as definitively cured.
- •Patient with an associated pathology considered incompatible with the study.§ Cardiac, renal, medullar, respiratory or hepatic insufficiency.
- •Significant neurological or psychiatric troubles.§ Symptomatic or evolutive troubles in CNS or metastasis.
- •Peripheral neuropathy > grade 2 NCI-CTC (version 3.0)
- •Previous allergy with polysorbate
- •Concomitant treatment with a drug tested in a clinical trial, participation to another clinical study, for the last thirty days or prior chemotherapy.
- •Patients non stable for the following 6 months or leaving at a great distance of the participating center.
结局指标
主要结局
Pathological complete response assessment of Taxotere-Erbitux combination
时间窗: After 18 weeks of treatment
次要结局
- Clinical, mammographic and ultrasound response Breast cancer conservation rate Overall and disease free survival Safety to treatments(After 18 weeks of treatment, at surgery and at five years (survival))
研究者
研究点 (12)
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