A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Recruiting
Observational Study
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
HER2
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 180 (estimated)
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Other
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About This Trial
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.
Trial Locations
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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…
Contacts