A Composite Assay for HER2-positive Early-stage Breast Cancer Management
NCT ID: NCT06762977
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2024-11-13
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Eligibility Criteria
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Inclusion Criteria
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
2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer
18 Years
ALL
No
Sponsors
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Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
NETWORK
Ospedale Di Summa-Perrino
UNKNOWN
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Principal Investigators
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Serena Di Cosimo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Paolo Verderio, PhD
Role: STUDY_CHAIR
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Locations
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Ospedale Di Summa-Perrino
Brindisi, , Italy
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INT 138/24
Identifier Type: -
Identifier Source: org_study_id
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