Clinical trial · Observational
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
NCT06762977CI-TRIAL-00084481HERCardrecruitingClinicalTrials.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)
The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S\*) in women with early-stage HER2-positive breast cancer. The study aims to determine whether these tools can predict event-free (EFS) and disease-free survival (DFS) in patients treated with neoadjuvant and/or adjuvant trastuzumab-based therapies.
Conditions
Conditions (2)
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 Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
| HER2 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S*
- timeFrame
- From the initiation of systemic therapy through to at least 3 years post-treatment.
- description
- To assess the prognostic value of the gene expression based classifier, with or without the integration of clinical-pathological variables, in patients receiving neoadjuvant and/or adjuvant chemotherapy with trastuzumab ± pertuzumab, with respect to event-free survival (EFS) and disease-free survival (DFS).
Secondary outcomes (2)
- measure
- Explorative evaluation of overall survival (OS) according to the value of S18 and S*
- timeFrame
- From the initiation of therapy through to at least 3 years post-treatment.
- description
- To assess the prognostic value of the gene expression based classifier, with or without the integration of clinical-pathological variables, in patients receiving neoadjuvant and/or adjuvant chemotherapy with trastuzumab ± pertuzumab, with respect to overall survival (OS).
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years 2. Operable breast cancer (stage I-III) 3. Any status of hormone receptor in the primary tumor, according to institutional guidelines 4. HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH) 5. Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab 6. Written informed consent from patients Exclusion Criteria: 1. Patient in follow-up for less than 3 years after surgery 2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer
References
Publications (0)
Data not yet available
No reference posted for this study.