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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.
The population includes women aged 18 or older with stage I-III HER2-positive breast cancer who received trastuzumab ± pertuzumab. Data and tumor tissue samples from this population have been collected prospectively from Istituto Nazionale dei Tumori IRCCS Fondazione Pascale, Naples (cohort A), and from Ospedale "Di Summa-Perrino", Brindisi (cohort B). The study integrates clinical-pathological and genomic data to refine and validate the prognostic capabilities of the S18 classifier.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ospedale Di Summa-Perrino
Brindisi, Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples, Italy
Start Date
November 13, 2024
Primary Completion Date
August 1, 2025
Completion Date
August 1, 2026
Last Updated
January 8, 2025
180
ESTIMATED participants
Lead Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators
NCT04704661
NCT04550494
Data Source & Attribution
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