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

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