A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
NCT ID: NCT05939128
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
625 participants
OBSERVATIONAL
2023-06-30
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Molecular Imaging of HER2 Expression in Breast Cancer Using [99mTc]Tc-G3-(G3S)3C Before Chemo/Targeted Therapy
NCT05923268
Multidisciplinary Approach to Breast Cancer Through the Study of Altered Transcriptomic and Immune Accompanied by the Identification of Extractable Markers From the Radiodiagnostic Bioimaging
NCT05809128
InheriteD brEast caNcer iTalian regIsTrY A Retrospective-prospective Observational Cohort Study to Evaluate Cancer Prevention Strategies in Women With a Deleterious Mutation in BRCA1-2
NCT05835739
Prognostic Value of Biomarkers in HR + / HER2 - Advanced Breast Cancer
NCT04683770
Factors Associated With Breast Cancer Risks and Outcomes
NCT07294703
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
-. 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D133HR00030
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.