RecruitingNCT06723990
Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
Prospective Observational Monocentric Study to Evaluate the Impact of the HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2-BREAST-DX
Sponsor
European Institute of Oncology
Enrollment
60 participants
Start Date
Oct 24, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
To prospectively evaluate the impact of HER2DX on the decision-making processes of the treating physicians and especially among the routine multidisciplinary tumour board, in defining type and setting of systemic therapy administration in patients with stage I-III HER2+ BC, and the degree of clinician's confidence in the treatment recommendation.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Patients ≥ 18 years of age;
- Histologically confirmed HER2+ breast cancer;
- Stage I-III breast cancer without evidence of distant metastases;
- Being candidate to neoadjuvant/adjuvant therapy and locoregional treatment (surgery +/- radiotherapy);
- Written informed consent, signed by the patient, to study-specific procedures (the consent will consist of 2 levels: level 1 specifically for patients enrolled in the primary endpoint cohort and level 2 for all patients);
Exclusion Criteria3
- HER2- BC;
- Stage IV breast cancer;
- Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Interventions
DRUGNeoadjuvant standard treatment for HER2+
NEOADJUVANT SETTING
DRUGAdjuvant standard treatment for HER2+
ADJUVANT SETTING
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06723990
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