NCT05522491尚未招募2 期
An Open-label, Single-arm, Single-center Exploratory Clinical Study of Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Breast Cancer
Hebei Medical University Fourth Hospital0 个研究点目标入组 30 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- ORR ORR
研究概览
简要总结
This is an open-label, single-arm, single-center,exploratory clinical study.
详细描述
This is an open-label, single-arm, single-center,exploratory clinical study initiated by the investigator to evaluate the efficacy of olaparib in recurrent and metastatic TNBC without BRCA1/2 mutation and methylated BRCA1 promoter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1. Age 18-70 years old, female;
- •Histologically confirmed recurrent and metastatic TNBC patients without BRCA1/2 mutation and BRCA1 promoter methylation.
- •Note: Triple-negative breast cancer is defined as estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor (HER2) negative. ER and PR negative were defined as: ER<1% positive, PR<1% positive. HER2 negativity was defined as: HER2 (-) or (1+) or HER2 (2+) FISH negative by immunohistochemistry.
- •3. The number of treatment lines at the stage of recurrence and metastasis should not exceed 2 lines.
- •4. According to RECIST1.1 criteria, there is at least one evaluable lesion;
- •ECOG physical condition score ≤ 1 point;
- •Expected survival period ≥ 3 months;
排除标准
- •1. Pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures;
- •Patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment;
- •Previous use of PARP inhibitors, including olaparib and other PARP inhibitors;
- •Known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, QT interval>450ms;
- •The toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia);
- •Clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy;
- •Patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases;
- •History of severe central nervous system disease (including epilepsy patients);
- •In the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment;
- •Known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections;
- •Patients who are allergic to this test drug or similar drugs;
- •Those who have participated in clinical trials of other drugs within 28 days before screening, or plan to participate in any other clinical trials during this study;
- •Any other disease or condition of clinical significance (such as active or uncontrolled infection, etc.) that the investigator believes may affect compliance with the protocol or affect the patient's signing of ICF
研究组 & 干预措施
Olapalib
Experimental
Olaparib Oral 300mg 2/day; 4 weeks (28 days) as a treatment cycle.
干预措施: Olaparib (Drug)
结局指标
主要结局
ORR ORR
时间窗: 24 month
Objective response rate
次要结局
- PFS(24 month)
研究者
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