JPRN-UMIN000051096招募中未知
Innovation of the 1st line strategy optimized as abemaciclib with endocrine therapy based on the ESR1 mutation of ctDNA for HR-positive HER2-negative advanced metastatic breast cancer patients - Multi-institutional phase 2 trial - JBCRG-M08(AMBER trial)
Japan Breast Cancer Research Group (JBCRG)0 个研究点目标入组 150 人开始时间: 2023年5月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18years-old 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Exclusion criteria for primary enrollment 1. Patients with ILD/pneumonitits. 2. Patients with central nervous system metastases or carcinomatous meningitis. 3. Patients with active double cancer other than breast cancer. 4. Patients with breast cancer other than hormone receptor-positive, HER2-negative one of synchronous or the disease-free period (< 5 years before the day of primary enrollment). 5. Patients with active systemic bacterial infection. 6. Patients with known infection with HBV or HCV or HIV. 7. Patients with a complication or history of heart failure of NYHA class II to IV, ischemic heart disease, or arrhythmia requiring treatment. 8. Patients with syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin. 9. Patients with poorly controlled diabetes mellitus. 10. Patients with poorly controlled hypertension. 11. Patients with symptoms of dyspnea at rest. 12. Patients with pleural effusion, ascites, or cardiac effusion requiring drainage. 13. Women with childbearing intention, pregnant, or lactating. 14. Patients who do not wish to continue abemaciclib. 15. Patients with major surgery within 14 days prior to randomization. 16. Patients with an experimental treatment in a clinical trial within the last 30 days or 5 half-lives in any other type of medical research. 17. Patients participating or planning to do in other clinical researches. 18. Patients with hypersensitivity to letrozole, anastrozole, fulvestrant, or abemaciclib. 19. Patients with serious and/or uncontrolled preexisting medical condition(s) in the judgement of the investigator. 20. Patients judged by the investigator or subinvestigator to be inappropriate to participate in this research. Exclusion criteria for secondary enrollment 1. Patients with accompanying active infection requiring systemic treatment. 2. Patients unwilling to continue abemaciclib. 3. Patients judged by the investigator or subinvestigator to be inappropriate to continue this research.
研究者
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JBCRG-M08(AMBER trial)Hormone receptor-positive, HER2-negative inoperable or recurrent breast cancerJPRN-jRCTs051220133Yoshinami Tetsuhiro150
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