NCT06791161Enrolling By Invitation不适用
A Multicenter Prospective Cohort Study of Adjuvant Therapy for BRCA1/2 Mutated Hormone Receptor-positive HER2-negative Early High-risk Breast Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月19日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Invasive Disease-Free Survival rate
研究概览
简要总结
To evaluate the efficacy and safety of different adjuvant treatment options after surgery for early high-risk breast cancer with BRCA1/2 mutation HR+/HER2
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ECOG score 0-1
- •ER>10%, PR>10%, HER2(0)/HER2(1+)/HER2(2+) and no amplification of FISH
- •BRCA1/2 gene mutation
- •No other site metastases were detected by imaging evaluation after surgical treatment
- •Non-PCR breast cancer after neoadjuvant therapy, or breast cancer with postoperative pathology indicating ≥pN2
- •The patient had no major organ dysfunction
排除标准
- •Allergic to the investigational drug, inability to take the drug orally, or refusal of the medication regimen
- •Has been enrolled in another study or has been discontinued for less than or equal to 4 weeks
- •There is serious dysfunction of vital organs (heart, liver, kidney)
- •Patients with other malignancies, except cured non-melanoma skin cancer, cervical carcinoma in situ and other tumors that have been cured for at least 5 years
- •In other acute infectious disease or chronic infectious disease activity period
- •A history of uncontrolled seizures, central nervous system disorders, or mental disorders
- •There is a known history of human immunodeficiency virus
研究组 & 干预措施
BRCA1/2 mutated HR+HER2- early high-risk breast cancer
干预措施: Endocrine drug +CDK4/6 inhibitor or PRAP inhibitor or Endocrine drug +CDK4/6 inhibitor+PARP inhibitor (Drug)
结局指标
主要结局
Invasive Disease-Free Survival rate
时间窗: 3 years
次要结局
- Distant relapse-free survival rate(3 years)
- Overall survival rate(3 years)
研究者
PENG YUAN
Head of department
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
研究点 (1)
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