NCT05939128进行中（未招募）不适用
A Multicentre, Single Arm, Non-interventional, Observational, Prospective Study to Assess the BRCA1/2m Prevalence, Treatment Approaches and Outcomes in HER2-negative High-risk Early Breast Cancer Patients in Russia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 625
- 试验地点
- 19
- 主要终点
- The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer
研究概览
简要总结
(Neo)adjuvant treatment approaches and outcomes
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years old
- •. Signed ICF, including patient's consent for genetic testing specimens from primary tumor and blood samples
- •Early HER2-negative BC (stages 2 and 3)
- •Compliance with at least 1 of the criteria for BRCA1/2 testing in accordance with the clinical guidelines of the Ministry of Health of the Russian Federation
- •Unknown BRCAm status or negative BRCAm PCR test
- •Performed surgical treatment (not more than 7 months before inclusion)
- •. High risk of recurrence according to one or more criteria:
- •incomplete pathomorphological response (in case of neoadjuvant therapy)
- •CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)
- •presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)
- •≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy)
- •Any other high risk criterion according to investigators opinion
- •The presence of postoperative or biopsy FFPE
排除标准
- •Participation in another clinical study with an investigational product during the last 3 months
- •Confirmation that the subject was already included in this study before
- •Absence of a written informed consent form; Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database
结局指标
主要结局
The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer
时间窗: 3 years
The prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer will be presented as a number of missing and non-missing records, median, standard deviation, 95% confidence interval for median
次要结局
- To describe treatment approaches of high-risk early HER2-negative breast cancer in routine practice in the general population, in the BRCAm and non-BRCAm population(3 years)
- To determine invasive disease-free survival for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population(3 years)
- To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population(3 years)
- To determine the prevalence of HRR mutations in HER2-negative breast cancer(3 years)
- To determine invasive disease-free survival in the HRRm population (including BRCA1/2)(3 years)
- To evaluate concordance between P53 expression and BRCAm(3 years)
- To assess the quality of life in patients with various types of adjuvant systemic therapy(3 years)
研究者
研究点 (19)
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