A Composite Assay for HER2-positive Early-stage Breast Cancer Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3), HER2. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S* [Time frame: From the initiation of systemic therapy through to at least 3 years post-treatment.]
Secondary outcome measures (2)
- Explorative evaluation of overall survival (OS) according to the value of S18 and S* [Time frame: From the initiation of therapy through to at least 3 years post-treatment.]
- Evaluation of pathological complete response (pCR) according to the value of S18 and S* [Time frame: Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 2 centers
- Ospedale Di Summa-Perrino — Brindisi
- Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale — Naples
Identifiers
NCT: NCT06762977 · INT 138/24