NCT06762977 A Composite Assay for HER2-positive Early-stage Breast Cancer Management
| NCT ID | NCT06762977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Breast Cancer Early Stage Breast Cancer (Stage 1-3) |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-11-13 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2024-11-13 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Serena Di Cosimo, MD, PhD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Frequently Asked Questions
Who can join the NCT06762977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer Early Stage Breast Cancer (Stage 1-3). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06762977 currently recruiting?
Yes, NCT06762977 is actively recruiting participants. Contact the research team at serena.dicosimo@istitutotumori.mi.it for enrollment information.
Where is the NCT06762977 trial being conducted?
This trial is being conducted at Brindisi, Italy, Naples, Italy.
Who is sponsoring the NCT06762977 clinical trial?
NCT06762977 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The principal investigator is Serena Di Cosimo, MD, PhD at Fondazione IRCCS Istituto Nazionale dei Tumori di Milano. The trial plans to enroll 180 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.