A Composite Assay for HER2-positive Early-stage Breast Cancer Management

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano180 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)HER2

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Ospedale Di Summa-Perrino

Brindisi, Italy

RECRUITING

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Naples, Italy

RECRUITING

Outcomes

Primary Outcomes

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

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*

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.

Central Contacts

Serena Di Cosimo, MD, PhD

CONTACT

+39 02 2390 2700 serena.dicosimo@istitutotumori.mi.it

Paolo Verderio, PhD

CONTACT

+39 02 2390 3201 paolo.verderio@istitutotumori.mi.it

Data from ClinicalTrials.gov

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