EUCTR2011-000621-80-GB进行中（未招募）1 期
Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
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
- 297
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
入选标准
- •- Women patients must be postmenopausal
- •- ER+, Human epidermal growth factor receptor 2 (Her2) metastatic breast cancer
- •- Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression
- •- No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy
- •- Eastern Cooperative Oncology Group (ECOG) performance status score of one or less
- •-Clinical laboratory values during Screening:
- •- Clinically normal prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) per investigator assessment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor. Prior treatment with Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor
- •- Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization
- •- Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
- •- Clinical or biochemical evidence of hyperaldosteronism or hypopituitarism
- •- Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments.
研究者
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