Clinical trial · Observational
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
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
NCT05939128CI-TRIAL-00111667ERAactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
(Neo)adjuvant treatment approaches and outcomes
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- 3 years
- description
- 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 (7)
- measure
- 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
- timeFrame
- 3 years
- description
- Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics.
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.