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

AstraZeneca

Status: Active, not recruiting

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT05939128

D133HR00030

Details and patient eligibility

About

(Neo)adjuvant treatment approaches and outcomes

Enrollment: 625 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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