Assessing Genomic Tools for Predicting Outcomes in Women with Early-Stage HER2-Positive Breast Cancer Treated with Trastuzumab

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. The study focuses on whether these tools can predict event-free survival EFS and disease-free survival DFS in patients treated with trastuzumab-based therapies, with or without pertuzumab. This observational study includes women aged 18 or older with operable stage I to III HER2-positive breast cancer. The study uses data and tumor tissue samples collected from two cohorts of patients who received neoadjuvant andor adjuvant trastuzumab pertuzumab therapies. It combines clinical, pathological, and genomic information to refine and validate the prognostic capability of the S18 classifier. No investigational treatments are administered as part of this observational research. Participants provide informed consent and their clinical and genomic data are analyzed. Researchers assess outcomes such as event-free survival and disease-free survival over at least three years following systemic therapy. They also explore overall survival and pathological complete response based on the classifier values. The studys total duration includes follow-up for at least three years after treatment initiation.

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