EUCTR2013-002717-35-ES进行中（未招募）1 期
A Phase 2, Randomized, Double Blind, Placebo Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor Positive and HER2 Normal
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
- 240
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
- •*Advanced, histologically confirmed breast cancer (primary tumor) that is ER+ and/or PgR+, and HER2-normal
- •*Cohort 1: patients who have not previously received hormone treatment for advanced breast cancer and the subset that is also AR+
- •*Cohort 2: patients who previously progressed following 1 hormone treatment for advanced breast cancer and the subset that is also AR+
- •*Up to one prior chemotherapy regimen for advanced disease is allowed for either Cohort
- •*Non-measurable bone and skin disease is allowed
- •*Patients must be post-menopausal
- •*Availability of a tumor specimen that enabled the definitive diagnosis of breast cancer;
- •*Eastern Cooperative Oncology Group (ECOG) performance status of 0 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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •*Current or previously treated brain metasis or active leptomeningeal disease;
- •*Abnormal hematology, liver function tests or creatinine laboratory values at screening;
- •*History of seizure or any condition that may predispose to seizure;
- •*History of loss of consciousness or transient ischemic attack within 12 months before randomization;
- •*An active gastrointestinal disorder affecting absorption (eg, gastrectomy, uncontrolled celiac disease);
- •*Treatment with any approved or investigational agent that blocks androgen synthesis or targets the AR (eg, abiraterone acetate, ARN 509, bicalutamide, enzalutamide, ODM 201, TAK 448, TAK 683, TAK 700). (Patients who received treatment for ? 28 days or placebo on an investigational study are acceptable.);
- •*Prior therapy (> 28 days) with exemestane in the metastatic setting. (Patients receiving exemestane in the adjuvant setting and having disease recurrence more than 1 year after treatment discontinuation are eligible.);
- •*Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
研究者
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