EUCTR2010-020101-32-GB进行中（未招募）1 期
A RANDOMIZED, PHASE II, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF ONARTUZUMAB AND/OR BEVACIZUMAB IN COMBINATION WITH PACLITAXEL IN PATIENTS WITH METASTATIC, TRIPLE-NEGATIVE BREAST CANCER
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 185
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
入选标准
- •Women age = 18 years
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Histologically confirmed ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast, with measurable or non-measurable metastatic or locally recurrent disease. Locally recurrent disease must not be amenable to resection with curative intent.
- •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 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Prior therapy with two or more regimens for metastatic breast cancer
- •Any systemic anti-cancer therapy within 3 weeks prior to Day 1 of Cycle 1
- •Major surgical procedure (except CNS surgery), open biopsy, or significant traumatic injury within 30 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
- •Prior therapy with a taxane for metastatic breast cancer
- •Prior therapy with bevacizumab, sorafenib, sunitinib, or other putative
- •VEGF pathway-targeted therapy following diagnosis of breast cancer
- •Prior exposure to experimental treatment targeting either the HGF or MET pathway
- •Prior therapy with hormones and/or trastuzumab
- •Unstable angina
- •Prior history of hypertensive crisis or hypertensive encephalopathy
- •New York Heart Association Grade = II congestive heart failure
- •History of myocardial infarction within 6 months prior to Day 1 of Cycle 1
- •Pregnancy (positive serum pregnancy test) or lactation
研究者
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