Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer (MBC) Patients With Germline BRCA1 and 2 Pathogenic Mutation in Korea
试验速览
- 阶段
- 不适用
- 入组人数
- 583
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-negative unresectable locally advanced or metastatic breast cancer.
详细描述
This is a multicenter, prospective, non-interventional study on the prevalence of germline pathogenic BRCA1/2 mutation (Blood) and somatic pathogenic BRCA1/2 mutation (Tissue, optional) in patients with HER2-negative unresectable locally advanced or metastatic breast cancer.
- For the assessment of germline mutational status of BRCA1 and BRCA2, (1)Collect peripheral blood from each subject. (2) Extract DNA from the collected blood. (3)From the extracted DNA, germline BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®
- For the assessment of somatic mutational status of BRCA1 and BRCA2, (1)Collect FFPE from about 100 subjects. (2) Extract DNA from the FFPE. (3)From the extracted DNA, somatic BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®
- Collect variables on the patients and compare clinical outcomes (Overall survival, Invasive Disease-free survival, Distant Disease-free survival, Progression free survival) that can be affected by clinicopathologic characteristics and type of treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 years old
- •Histologically confirmed, unresectable locally advanced or metastatic breast invasive carcinoma
- •Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
- •Germline mutational status of BRCA1 and/or BRCA2 can be known or unknown
- •Signed written informed consent
- •The patient is regarded as good candidate for active palliative management at time of enrollment. The patient with terminal cancer which is not appropriate for further endocrine treatment or chemotherapy cannot be enrolled to this study.
排除标准
- •HER2 positive breast cancer
- •Amenable to curative surgery
结局指标
主要结局
Progression free survival
时间窗: Length of time from the first date of each line of palliative endocrine treatment or chemotherapy until the date of the first documented progression of breast cancer or death of any cause,, assessed up to 60 months
Progression free survival of each of palliative systemic treatment
次要结局
- Overall survival 2(Length of time from the first date of the first line of chemotherapy, assessed up to 60 months)
- Overall survival 1(Length of time from the date of first neoadjuvant chemotherapy or curative surgery until death for any cause,, assessed up to 60 months)
- Disease-free survival(Length of time from the date of first neoadjuvant chemotherapy or curative surgery until the date of the first recurrence of breast cancer, diagnosis of second invasive cancer, or death for any cause whichever comes first, assessed up to 60 months)
研究者
Yeon Hee Park
M.D., Ph.D., Division of hematology and oncology
Samsung Medical Center