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

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ClinicalTrials.gov Identifier: NCT05939128
Recruitment Status : Recruiting
First Posted : July 11, 2023
Last Update Posted : June 21, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date July 3, 2023
First Posted Date July 11, 2023
Last Update Posted Date June 21, 2024
Actual Study Start Date June 30, 2023
Estimated Primary Completion Date June 30, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2023)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 3, 2023)
  • 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.
  • 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
  • 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
  • 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
  • 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
  • To evaluate concordance between P53 expression and BRCAm [ Time Frame: 3 years ]
    Testing the archived tumour specimen and blood
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
Official 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
Brief Summary (Neo)adjuvant treatment approaches and outcomes
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
tumor and blood samples
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
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 3, 2023)		 750
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2027
Estimated Primary Completion Date June 30, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Listed Location Countries Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number NCT05939128
Other Study ID Numbers D133HR00030
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party AstraZeneca
Original Responsible Party Same as current
Current Study Sponsor AstraZeneca
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account AstraZeneca
Verification Date June 2024