A non-interventional prospective study of Early HER2-negative high-risk breast cancer and BRCA1/2 mutations prevalence in RussiA - ERA

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:
• a) incomplete pathomorphological response (in case of neoadjuvant therapy)
• b) CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)
• c) presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)
• d) ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy)
• e) Any other high risk criterion according to investigators opinion
• - The presence of postoperative or biopsy FFPE