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Active, not recruiting

NCT Number: NCT05939128

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

(Neo)adjuvant treatment approaches and outcomes

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • incomplete pathomorphological response (in case of neoadjuvant therapy)
  • CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)
  • presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)
  • ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy)
  • 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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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. 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

  4. 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

  5. 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

  6. To evaluate concordance between P53 expression and BRCAm

    Time frame: 3 years

    Testing the archived tumour specimen and blood

  7. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ERA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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