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

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT05939128
• Lead Sponsor: AstraZeneca

Brief Summary

(Neo)adjuvant treatment approaches and outcomes

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Study First Submitted: 2023-07-03
• Study First Submitted QC: 2023-07-03
• Study First Posted: 2023-07-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2027-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 625

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer	3 years	The prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer will be presented as a number of missing and non-missing records, median, standard deviation, 95% confidence interval for median

Secondary Outcome Measures

Name	Time	Method
To describe treatment approaches of high-risk early HER2-negative breast cancer in routine practice in the general population, in the BRCAm and non-BRCAm population	3 years	Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics.
To determine invasive disease-free survival for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population	3 years	The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis
To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population	3 years	The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis
To determine the prevalence of HRR mutations in HER2-negative breast cancer	3 years	Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
To determine invasive disease-free survival in the HRRm population (including BRCA1/2)	3 years	Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
To evaluate concordance between P53 expression and BRCAm	3 years	Testing the archived tumour specimen and blood
To assess the quality of life in patients with various types of adjuvant systemic therapy	3 years	completed WHOQOL-BREF questionnaire will be assessed

Trial Locations

Locations (1)

Research Site; 🇷🇺 Yaroslavl, Russian Federation