Assessing a genomic classifier for HER2-positive early-stage breast cancer management
A Composite Assay for HER2-positive Early-stage Breast Cancer Management
This study is testing a new genetic tool to see if it can help predict how well women with early-stage HER2-positive breast cancer will do after treatment with certain therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab |
| Locations | 2 sites (Brindisi and 1 other locations) |
| Trial ID | NCT06762977 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 or older with operable HER2-positive breast cancer stages I-III who have received trastuzumab-based therapies.
Not a fit: Patients with a prior diagnosis of invasive cancer before their breast cancer diagnosis or those in follow-up for less than 3 years after surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate prognosis for patients with HER2-positive early-stage breast cancer, guiding treatment decisions.
How similar studies have performed: Other studies have shown promise in using genomic classifiers for breast cancer prognosis, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Brindisi and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.