A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
About this trial
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
Qualifiers
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)
Disqualifiers
Patient in follow-up for less than 3 years after surgery
A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator
Ospedale Di Summa-Perrino
Collaborator
Source ClinicalTrials.gov