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

May 14, 2026 updated by: AstraZeneca

A Multicentre, Single Arm, Non-interventional, Observational, Prospective Study to Assess the BRCA1/2m Prevalence, Treatment Approaches and Outcomes in HER2-negative High-risk Early Breast Cancer Patients in Russia

(Neo)adjuvant treatment approaches and outcomes

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

625

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russia
      • Arkhangelsk, Russia
        • Research Site
      • Barnaul, Russia
        • Research Site
      • Belgorod, Russia
        • Research Site
      • Chelyabinsk, Russia
        • Research Site
      • Grozny, Russia
        • Research Site
      • Irkutsk, Russia
        • Research Site
      • Khanty-Mansiysk, Russia
        • Research Site
      • Krasnodar, Russia
        • Research Site
      • Krasnoyarsk, Russia
        • Research Site
      • Moscow, Russia
        • Research Site
      • Nal'chik, Russia
        • Research Site
      • Nyzhny Novgorod, Russia
        • Research Site
      • Ryazan, Russia
        • Research Site
      • Saint Petersburg, Russia
        • Research Site
      • Severodvinsk, Russia
        • Research Site
      • Sochi, Russia
        • Research Site
      • Ufa, Russia
        • Research Site
      • Vladivostok, Russia
        • Research Site
      • Yaroslavl, Russia
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 3 years
Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics.
3 years
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
Time Frame: 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
3 years
To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population
Time Frame: 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
3 years
To determine the prevalence of HRR mutations in HER2-negative breast cancer
Time Frame: 3 years
Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
3 years
To determine invasive disease-free survival in the HRRm population (including BRCA1/2)
Time Frame: 3 years
Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
3 years
To evaluate concordance between P53 expression and BRCAm
Time Frame: 3 years
Testing the archived tumour specimen and blood
3 years
To assess the quality of life in patients with various types of adjuvant systemic therapy
Time Frame: 3 years
completed WHOQOL-BREF questionnaire will be assessed
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 11, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D133HR00030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe