Actively Recruiting
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-01-08
180
Participants Needed
2
Research Sites
89 weeks
Total Duration
On this page
Sponsors
F
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead Sponsor
I
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Operable breast cancer at stage I, II, or III
- Any hormone receptor status in the primary tumor as per institutional guidelines
- HER2-positive primary tumor confirmed by immunohistochemistry or ERBB2 gene amplification analysis
- Received neoadjuvant and/or adjuvant therapy based on trastuzumab with or without pertuzumab
- Provided written informed consent to participate
You will not qualify if you...
- Follow-up period less than 3 years after surgery
- Prior diagnosis of invasive cancer before breast cancer diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ospedale Di Summa-Perrino
Brindisi, Italy, 72100
Actively Recruiting
2
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples, Italy, 80131
Actively Recruiting
Research Team
S
Serena Di Cosimo, MD, PhD
CONTACT
P
Paolo Verderio, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here