(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

Study population will consist of early breast cancer HER2-negative patients with high risk of recurrence with available medical history, surgery or biopsy FFPE from primary tumor. It is estimated that approximately 750 patients will be enrolled in approximately 25 sites