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

(Neo)adjuvant treatment approaches and outcomes

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: 1. incomplete pathomorphological response (in case of neoadjuvant therapy) 2. CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy) 3. presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy) 4. ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy) 5. 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