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
52 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
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 and/or 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 study's total duration includes follow-up for at least three years after treatment initiation.
CONDITIONS
Brief 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 of the primary tumor
- HER2-positive tumor confirmed by immunohistochemistry 3+ or 2+ with positive ERBB2 gene amplification
- Received neoadjuvant and/or adjuvant trastuzumab with or without pertuzumab
- Provided written informed consent
You will not qualify if you...
- Follow-up 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to time of definitive surgery within 10 months of starting neoadjuvant treatment
Participants provide existing clinical-pathological and genomic data as well as tumor tissue samples obtained during routine care for analysis.
Duration - At least 3 years
Participants are observed for event-free survival, disease-free survival, and overall survival for at least 3 years following the initiation of systemic therapy.
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
P
Paolo Verderio, PhD
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
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