Assessing a genomic classifier for HER2-positive early-stage breast cancer management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the prognostic value of a genomic classifier (S18) and its refined version (S*) in women with early-stage HER2-positive breast cancer. It aims to determine the ability of these classifiers to predict event-free survival (EFS) and disease-free survival (DFS) in patients treated with trastuzumab-based therapies. The study collects clinical-pathological and genomic data from women aged 18 or older with operable breast cancer stages I-III, integrating this information to enhance the prognostic capabilities of the classifiers.

Why it matters

Who can join: the full rules

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

Where it's running

• Ospedale Di Summa-Perrino
  Brindisi, Italy Recruiting
• Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
  Naples, Italy Recruiting

Study contacts

• Principal investigator: Serena Di Cosimo, MD, PhD — Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
• Study coordinator: Serena Di Cosimo, MD, PhD
• Email: serena.dicosimo@istitutotumori.mi.it
• Phone: +39 02 2390 2700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.