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

Last updated: January 7, 2025
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06762977
INT 138/24
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 institutionalguidelines

  4. HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positivephenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2gene 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

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

Study Design

Total Participants: 180
Study Start date:
November 13, 2024
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Ospedale Di Summa-Perrino

    Brindisi, 72100
    Italy

    Active - Recruiting

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

    Naples, 80131
    Italy

    Active - Recruiting

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