Breast Cancer Early Stage Breast Cancer (Stage 1-3), HER2
Conditions
Keywords
HER2-positive, operable breast cancer, gene-expression based classifier, prognosis
Brief 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.
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.
Interventions
None listed
Sponsors
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Ospedale Di Summa-Perrino
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years 2. Operable breast cancer (stage I-III) 3. Any status of hormone receptor in the primary tumor, according to institutional guidelines 4. 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) 5. Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab 6. Written informed consent from patients
Exclusion criteria
1. Patient in follow-up for less than 3 years after surgery 2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S* | From the initiation of systemic therapy through to at least 3 years post-treatment. | To assess the prognostic value of the gene expression based classifier, with or without the integration of clinical-pathological variables, in patients receiving neoadjuvant and/or adjuvant chemotherapy with trastuzumab ± pertuzumab, with respect to event-free survival (EFS) and disease-free survival (DFS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Explorative evaluation of overall survival (OS) according to the value of S18 and S* | From the initiation of therapy through to at least 3 years post-treatment. | To assess the prognostic value of the gene expression based classifier, with or without the integration of clinical-pathological variables, in patients receiving neoadjuvant and/or adjuvant chemotherapy with trastuzumab ± pertuzumab, with respect to overall survival (OS). |
| Evaluation of pathological complete response (pCR) according to the value of S18 and S* | Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment. | To evaluate the predictive value of the gene expression based classifier in relation to pathological complete response (i.e., absence of breast cancer cells in surgical specimens) following neoadjuvant therapy with chemotherapy plus trastuzumab ± pertuzumab. |
Countries
Italy
Contacts
Primary ContactSerena Di Cosimo, MD, PhD
Backup ContactPaolo Verderio, PhD
Outcome results
None listed