A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Recruiting · NCT06762977 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 18 years
- Operable breast cancer (stage I-III)
- Any status of hormone receptor in the primary tumor, according to institutional guidelines
- HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH)
- Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab
- Written informed consent from patients
Exclusion criteria
- Patient in follow-up for less than 3 years after surgery
- A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Where it is running
2 locations listed.
- Ospedale Di Summa-Perrino - Brindisi, Italy
- Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale - Naples, Italy