Clinical trial · Observational
HER2-low Unresectable and/or 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)-Low Unresectable and/or 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 3,150 adult patients with HER2-negative (IHC 0, + or IHC2+/ISH-) unresectable or metastatic BC enrolled to the study in order to obtain approximately 2,000 patients with confirmed HER2 low status (IHC1+ or IHC2+/ISH ).
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 (2)
- measure
- To study the overall prevalence of HER2-low among patients with HER2-negative mBC, based on reassessment of historical HER2 fixed tissue IHC stained slides assay in the Russian Federation
- timeFrame
- 12 months
- measure
- To study the clinical-pathological, histopathological and demographic profiles of patients of HR-positive and HR-negative HER2-low status among unresectable and/or mBC patients identified as HER2-negative HR-positive/negative
- timeFrame
- 12 months
- description
- Clinical and demographic data, as well as other study variables will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quantiles, minimum and maximum, depending on the type of variable (continuous or categorical) for the total sample and all subgroups (if applicable).
Secondary outcomes (5)
- measure
- To describe data on the diagnostic algorithms and therapeutic tactics in patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed diagnosis of unresectable and/or metastatic BC established between the 1st July 2021 and the 1st July 2022. * Patients have HER2-negative status (IHC0, IHC1+, IHC2+/ISH-) obtained in the local laboratory. -. Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status\* by the reference laboratory. * Patients have documented hormonal status (ER, PR) IHC score. * Age ≥ 18 years at the time of inclusion. * Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted Exclusion Criteria: * Patients with previous HER2 positive status in the anamnesis at the diagnosis or after the diagnosis of breast cancer. * Presence of other malignancies within period since diagnosis until the timepoint of data collection. * Patients receiving trastuzumab deruxtecan currently or received in anamnesis. * The participation in any randomised controlled trial within period since diagnosis until end of study.
References
Publications (0)
Data not yet available