Landscape Ofhomologous Recombination-related (HRR) Genes Mutations and HRD, and Correlation With Survival in HER2-lowbreast Cance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- 1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
研究概览
简要总结
This is a cross-sectional and an observational study, investigator-initiated study in HER2-low breast cancer patients. Approximately 255 subjects with HRD (homologous recombination deficiency) assessment will be enrolled in this study to examine the distribution and features of HRD/HRR (homologous recombination repair).
In this study, investigators plan to clarify the frequency of HRR/HRD in Chinese patients with HER2-low breast cancer.
In addition, it is planned to investigate any association between invasive disease-free survival (iDFS)/overall survival (OS) and HRD/HRR in HER2-low breast cancer patients.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-70 years with pathologically confirmed HER2-low breast cancer (defined as IHC 2+/ISH- or IHC 1+ per ASCO/CAP guidelines);
- •ECOG performance status of 0 or 1;
- •Treatment-naïve operable primary breast cancer with completed homologous recombination deficiency (HRD) assessment;
- •5）Absence of distant metastasis; 6）Availability of adequate tumor tissue and blood samples for biomarker analysis.
排除标准
- •Recurrent or inoperable locally advanced breast cancer;
- •Bilateral breast cancer;
- •History of other malignant tumors within the past 5 years;
- •Incomplete clinical or pathological data.
结局指标
主要结局
1.To assess the distribution characteristics of mHRR/HRD in breast cancer with low HRE2 expression in Chinese population
时间窗: At the time of 4 weeks after surgery
the distribution and features of HRD /HRR is evaluated.
次要结局
- To assess the clinical characteristics between patients with mutations and non-mutation(At the time of 4 weeks after surgery)
- To compare the correlation between iDFS/OS and different adjuvant treatment regimens for breast cancer with low HER2 expression(At the time of 36 months after surgery)
- To investigate the HRR/HRD characteristics and clinical characteristics (family history, age pathological feature es, etc.) of breast cancer patients with low HER2 expression(At the time of 4 weeks after surgery)
研究者
Chang Gong
Chief physician
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University