Clinical trial · Observational
HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Russian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
- 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)
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period). Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.
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
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (7)
- measure
- To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
- timeFrame
- up to 6 month
- description
- Demographics characteristics : age(years)
- measure
- To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
- timeFrame
- up to 6 month
- description
- \- Demographics characteristics : gender
- measure
- To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
- timeFrame
- up to 6 month
- description
- \- Demographics characteristics : body mass index \[BMI\]);
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion; * The diagnosis of mBC was established between the 1st July 2021 and the 1st July 2022; * Patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis; * Age ≥ 18 years at the time of inclusion. Exclusion Criteria: * Presence of other malignancies within period since diagnosis until the timepoint of data collection; * Patients receiving trastuzumab deruxtecan currently or in the anamnesis; * The participation in any randomized controlled trial within period since diagnosis until end of study.
References
Publications (0)
Data not yet available