EUCTR2013-001862-41-AT进行中（未招募）1 期
A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive HER2-negative 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
- 372
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
- •--patient has T2-T4, any N, M0 breast cancer and measurable tumor
- •--diagnostic biopsy available for analysis of PIK3CA mutation, ER/PR, HER2 status and Ki67 levels
- •--estrogen-receptor and/or proesterone positive breast cancer as per local or Novartis central lab test
- •--HER2 negative breast cancer
- •--known PIK3CA mutation status
- •--Ki67 level status determined centrally
- •--ECOG performance status < or = 1
- •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 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 353
排除标准
- •--locally recurrent or metastatic disease
- •--patient has received any systemic therapy (eg chemo-, targeted- or immuno-therapy) or radio-therapy for current disease
- •--patient with clinically manifest diabetes mellitus (fasting glucose >140mg/dl or 7.7 mmol.L), or documented steroid induced diabetes mellitus
研究者
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