A Composite Assay for Managing Early-Stage HER2-Positive Breast Cancer Using Genomic Classifiers

What this Trial Is About

Researchers are evaluating the prognostic value of a genomic classifier called S18 and its refined version S* in women with early-stage HER2-positive breast cancer. This study focuses on women aged 18 or older who have stage I-III HER2-positive breast cancer and have been treated with trastuzumab-based therapies, with or without pertuzumab. The purpose is to determine if these genomic tools can predict event-free survival (EFS) and disease-free survival (DFS) in these patients. The study includes women who received neoadjuvant and/or adjuvant trastuzumab ± pertuzumab therapy. Clinical-pathological and genomic data, including tumor tissue samples, have been collected prospectively from two cohorts at Italian cancer institutes. These data are used to refine and validate the prognostic capabilities of the S18 classifier and its refined version S*. Participants’ clinical and genomic information is analyzed to predict outcomes such as event-free survival and disease-free survival from the start of systemic therapy through at least three years post-treatment. The study involves long-term follow-up monitoring to assess these outcomes, integrating data collected at baseline and during treatment. Researchers aim to improve breast cancer management by better understanding how genomic classifiers relate to patient prognosis.

A Composite Assay for HER2-positive Early-stage Breast Cancer Management