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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 : May 10, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
(Neo)adjuvant treatment approaches and outcomes

Condition or disease
Breast Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 30, 2023
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
tumor and blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05939128


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Russian Federation
Research Site Recruiting
Arkhangelsk, Russian Federation
Research Site Recruiting
Barnaul, Russian Federation
Research Site Recruiting
Belgorod, Russian Federation
Research Site Recruiting
Chelyabinsk, Russian Federation
Research Site Withdrawn
Ekaterinburg, Russian Federation
Research Site Recruiting
Grozny, Russian Federation
Research Site Recruiting
Irkutsk, Russian Federation
Research Site Withdrawn
Kazan, Russian Federation
Research Site Recruiting
Khanty-Mansiysk, Russian Federation
Research Site Recruiting
Krasnodar, Russian Federation
Research Site Recruiting
Krasnoyarsk, Russian Federation
Research Site Recruiting
Moscow, Russian Federation
Research Site Withdrawn
Moscow, Russian Federation
Research Site Not yet recruiting
Moscow, Russian Federation
Research Site Recruiting
Nalchik, Russian Federation
Research Site Recruiting
Nyzhny Novgorod, Russian Federation
Research Site Recruiting
Ryazan, Russian Federation
Research Site Recruiting
Saint Petersburg, Russian Federation
Research Site Withdrawn
Samara, Russian Federation
Research Site Recruiting
Severodvinsk, Russian Federation
Research Site Recruiting
Sochi, Russian Federation
Research Site Withdrawn
Tomsk, Russian Federation
Research Site Recruiting
Ufa, Russian Federation
Research Site Recruiting
Vladivostok, Russian Federation
Research Site Recruiting
Yaroslavl, Russian Federation
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05939128    
Other Study ID Numbers: D133HR00030
First Posted: July 11, 2023    Key Record Dates
Last Update Posted: May 10, 2024
Last Verified: May 2024
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases