EUCTR2013-004587-65-IT进行中（未招募）1 期
A phase Ib/II study of LEE011 in combination with fulvestrant and BYL719 or BKM120 in the treatment of postmenopausal women with hormone receptor positive, HER2 negative locally recurrent or advanced metastatic breast cancer
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
- 220
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
- •- Postmenopausal, Hormone receptor positive (HR+), HER2 negative breast cancer;
- •- Phase Ib - Unlimited number of lines of endocrine therapy and up to two lines of cytotoxic chemotherapy in the metastatic setting.
- •- Phase II - Unlimited number of lines of endocrine therapy and one line of
- •cytotoxic chemotherapy in the metastatic setting
- •Other protocol-defined inclusioncriteria may apply
- •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 47
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 173
排除标准
- •- HER2-overexpression in the patient's tumor tissue;
- •- inadequate bone marrow function or evidence of end-organ damage;
- •- severe or uncontrolled medical issues;
- •- diabetes mellitus.
- •Other protocol-defined exclusion criteria may apply
研究者
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