NCT06762977 A Composite Assay for HER2-positive Early-stage Breast Cancer Management
| NCT ID | NCT06762977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2025-08 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
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
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