EUCTR2020-001824-33-PT进行中（未招募）1 期
A randomized, multicenter, double-blind phase 3 study of amcenestrant (SAR439859) plus palbociclib versus letrozole plus palbociclib for the treatment of patients with ER (+), HER2 (-) breast cancer who have not received prior systemic anti-cancer treatment for advanced disease - AMEERA-5
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
- 1,333
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
- All
入选标准
- •-Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment
- •-Confirmed diagnosis of ER+/HER2- breast cancer
- •-No prior systemic treatment for loco-regional recurrent or metastatic disease
- •-Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •-Participants should be willing to provide tumor tissue
- •-Capable of giving informed consent
- •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 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 533
排除标准
- •-Known active brain metastases
- •-Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD)
- •-Inadequate organ and marrow function
- •-Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy
- •-Pregnant, breastfeeding, or woman of child bearing potential unwilling to use recommended contraception methods
- •-Male participants who disagree to follow contraception
- •-Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term
- •-Participants with significant concomitant illness
研究者
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