EUCTR2010-020101-32-ES进行中（未招募）1 期
A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF METMAB IN COMBINATION WITHPACLITAXEL AND BEVACIZUMAB IN PATIENTS WITH METASTATIC, TRIPLE-NEGATIVE BREAST CANCEREstudio aleatorizado, en fase II, multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de metmab en combinación con paclitaxel y bevacizumab en pacientes con cáncer de mama metastásico triple negativo
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •* Mujeres >= 18 años de edad
- •* Estado funcional de 0 ó 1 según el Eastern Cooperative Oncology Group
- •*Adenocarcinoma de mama triple negativo (ER-negativo, PR-negativo y HER-2 negativo) confirmado histológicamente, con enfermedad metastásica o localmente recurrente mensurable o no mensurable
- •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
- •* Tratamiento previo con dos o más pautas para el cáncer de mama metastásico.* Cualquier tratamiento antineoplásico sistémico en las 3 semanas previas al día 1 del ciclo 1.* Intervención de cirugía mayor (excepto cirugía del SNC), biopsia abierta o lesión traumática importante en los 30 días anteriores al día 1 del ciclo 1, o previsión de la necesidad de una intervención de cirugía mayor durante el curso del estudio.*Tratamiento previo con un taxano para el cáncer de mama metastásico.* Tratamiento previo con bevacizumab, sorafenib, sunitinib u otros supuestos tratamientos dirigidos a la vía del VEGF tras el diagnóstico de cáncer de
- •mama.*Tratamiento previo con hormonas y/o trastuzumab. *Angina inestable.*Antecedentes de crisis hipertensivas o encefalopatía hipertensiva. * Insuficiencia cardíaca congestiva de grado ≥ II de la New York Heart Association. *Antecedentes de infarto de miocardio en los 6 meses previos al día 1 del ciclo 1. *Embarazo (prueba de embarazo en suero positiva) o lactancia
研究者
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