Clinical trial · Observational
An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
Epidemiological, Prospective and Observational Study on the HER2 Status in Breast Invasive Carcinomas Assessed by Immunohistochemistry (IHC) and Silver In-situ Hybridization (SISH) in a Sample of Latin-American Patients
NCT02535026CI-TRIAL-00026897completedResults postedClinicalTrials.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 is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.
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 Participants
- description
- Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies will be considered for analysis in this study.
Primary outcomes (19)
- measure
- Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures
- timeFrame
- Baseline up to 30 months
- description
- HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER2 negative (-)." If the score is 2+, it's called "borderline." A score of 3+ is called "HER2 positive." Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal.
- measure
- Percentage of Participants With Different Phenotypes of Breast Cancer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer Exclusion Criteria: * Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study * Cancer samples that have received previous chemotherapy treatment
References
Publications (0)
Data not yet available
No reference posted for this study.