JPRN-jRCT2080221950已完成3 期
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 481
研究概览
简要总结
The significant PFS improvement with bevacizumab is consistent with previous placebo-controlled first-line trials in mBC. Results do not support using baseline pVEGF-A to identify patients benefitting most from bevacizumab.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast, with measurable or non-measurable locally recurrent or metastatic disease.
- •- Locally recurrent disease must not be amenable to resection with curative intent.
- •- ECOG performance status of 0 or 1
- •- For women of childbearing potential, use of an acceptable and effective method of non-hormonal contraception
- •- For patients who have received recent radiotherapy, recovery prior to randomization from any significant acute toxicity, and radiation treatments have to be completed more than 3 weeks from randomization
排除标准
- •Disease-Specific Exclusions:
- •- HER2-positive status
- •- Prior chemotherapy for locally recurrent or metastatic disease
- •- Prior hormonal therapy < 2 weeks prior to randomization
- •- Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has been for at least 12 months prior to randomization
- •- Investigational therapy within 28 days of randomization
- •General Medical Exclusions:
- •- Life expectancy of < 12 weeks
- •- Inadequate organ function
- •- Uncontrolled serious medical or psychiatric illness
- •- Active infection requiring intravenous (IV) antibiotics at screening
- •- Pregnancy or lactation
- •- History of other malignancies within 5 years prior to screening, except for tumors with a negligible risk for metastasis or death
研究者
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