NCT Number: NCT06762977
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.
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Request Info18 year and older
All sexes
Observational
Ospedale Di Summa-Perrino, Brindisi, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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).
Time frame: 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).
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Paolo Verderio, PhD
CONTACT
Serena Di Cosimo, MD, PhD
CONTACT
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Other
Acronym: HERCard
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