A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA

Study Overview
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Brief Summary
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(Neo)adjuvant treatment approaches and outcomes

Official Title
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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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics. | 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 | The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis | 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 | The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis | 3 years | 
| To determine the prevalence of HRR mutations in HER2-negative breast cancer | Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status | 3 years | 
| To determine invasive disease-free survival in the HRRm population (including BRCA1/2) | Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status | 3 years | 
| To evaluate concordance between P53 expression and BRCAm | Testing the archived tumour specimen and blood | 3 years | 
| To assess the quality of life in patients with various types of adjuvant systemic therapy | completed WHOQOL-BREF questionnaire will be assessed | 3 years |