RecruitingNCT06762977
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Enrollment
180 participants
Start Date
Nov 13, 2024
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria6
- Age ≥ 18 years
- Operable breast cancer (stage I-III)
- Any status of hormone receptor in the primary tumor, according to institutional guidelines
- 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)
- Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab
- Written informed consent from patients
Exclusion Criteria2
- Patient in follow-up for less than 3 years after surgery
- A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06762977
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