Clinical trial · Observational
A Study on the Epidemiology and Testing of Human Epidermal Growth Factor-Receptor 2 (HER2) in Breast Cancer in Germany
A Non-interventional Study on the Epidemiology and Testing of HER2 in Breast Cancer in Germany
NCT02666261CI-TRIAL-00037740completedClinicalTrials.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)
This non-interventional study will collect data from routine diagnostics on HER2 testing of breast cancer in Germany.
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 (1)
- label
- Breast Cancer Pathology Samples
- description
- Data on the epidemiology and HER2 testing of breast cancer will be collected from pathology routine diagnostics.
Primary outcomes (1)
- measure
- Number of HER2 Positive Samples
- timeFrame
- 1 day (this is a single time point study)
Secondary outcomes (15)
- measure
- Number of HER2 Positive Samples by Carcinoma Subtype (No Special Type\Ductal, Lobular, Other Special Type)
- timeFrame
- 1 day (this is a single time point study)
- measure
- Number of HER2 Positive Samples by Sample Extraction (Biopsy versus Resectate)
- timeFrame
- 1 day (this is a single time point study)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Samples derived from men and women of age greater than or equal to (\>/=) 18 years * Samples derived from participants with any stage of histologically confirmed invasive breast cancer with HER2 diagnostics performed within routine (histo-)pathological workup or * (Histo-)Pathological work-up of the tumor sample as at or after start of this study * Available information on the year of birth of the participant * No pre-selection of tumor samples is allowed. Tumor samples have to be documented consecutively in the order of their (histo-)pathological work-up. Exclusion Criteria: * Sample derived from participants with any stage of breast cancer with no HER2 diagnostics performed at the time of routine (histo-)pathological work-up. * Samples derived prior to the start of this study.
References
Publications (0)
Data not yet available
No reference posted for this study.