Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
Recruiting now
Conditions studied: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
In brief
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.
Key facts
- Study ID
- NCT06723990
- Run by
- European Institute of Oncology
- People needed
- 60
- Starts
- 2024-10-24
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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);
You may not qualify if…
- HER2- BC;
- Stage IV breast cancer;
- Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Where it is running
- Istituto Europeo di Oncologia — Milan, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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