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

Recruitingn/aAges 18 Years - anyAllFondazione IRCCS Istituto Nazionale dei Tumori, M…
NCT06762977 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

2 sites
Ospedale Di Summa-Perrino
Brindisi, Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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