Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
Recruiting · NCT06723990 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Adjuvant standard treatment for HER2+Neoadjuvant standard treatment for HER2+
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- Istituto Europeo di Oncologia - Milan, Italy, Italy