A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patient in follow-up for less than 3 years after surgery
A prior diagnosis of invasive cancer before the diagnosis of breast cancer
Trial population
Clinical information and paraffin-embedded tumor tissue samples from HER2-positive operable breast cancer patients included in the study were prospectively and consecutively collected at the participating centers and are now being analyzed for the purpose of the protocol.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S*
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 systemic therapy through to at least 3 years post-treatment.Secondary outcomes
1
Explorative evaluation of overall survival (OS) according to the value of S18 and S*
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
From the initiation of therapy through to at least 3 years post-treatment.2
Evaluation of pathological complete response (pCR) according to the value of S18 and S*
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.
Time frame
Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Lead sponsor
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator
Ospedale Di Summa-Perrino
Collaborator
Source ClinicalTrials.gov