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

Plain Language Summary

Simplified for easier understanding

This study is testing a combined blood and tissue test to help doctors better manage HER2-positive early breast cancer — specifically to see whether the assay can predict treatment response and guide decisions about treatment after surgery. **You may be eligible if...** - You are 18 or older - You have operable (surgically removable) breast cancer, stage I–III - Your tumor tests positive for HER2 (a protein that drives cancer growth) - You have received or will receive chemotherapy plus trastuzumab (with or without pertuzumab) - You have been followed for at least 3 years after surgery **You may NOT be eligible if...** - You were diagnosed with another invasive cancer before your breast cancer diagnosis - You have been followed for less than 3 years after surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(2)

Ospedale Di Summa-Perrino

Brindisi, Italy

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Naples, Italy

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NCT06762977


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