EUCTR2018-003648-22-AT进行中（未招募）1 期
Ribociclib-endocrine combination therapy versus chemotherapy as 1st line treatment in patients with visceral metastatic breast cancer.A multicenter, randomized phase III trial.
SAKK0 个研究点目标入组 400 人开始时间: 2019年8月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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. Histologically or cytologically confirmed diagnosis of hormone receptor positive (ER+ =10%), HER2 negative, metastatic breast cancer.
- •2. Measurable visceral disease according to RECIST v1.1. Visceral disease in liver and/or lung. Peritoneal and/or pleural metastases only are accepted, with the condition to be measurable
- •3. Postmenopausal women (without ovarian function suppression)
- •4. Mono-chemotherapy is a reasonable treatment option
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •1. Visceral crisis (clinical judgement of treating investigator)
- •2. Any prior systemic anti-cancer treatment for advanced stage breast cancer
- •3. Prior treatment with adjuvant CDK4/6 inhibitor
研究者
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