Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Institute of Oncology
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
HER2- BC;
Stage IV breast cancer;
Lack of informed consent because of patient's incapable of discernment or unwilling to participate;
Trial population
HER2 positive breast cancer patients with stage I-III
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neoadjuvant standard treatment for HER2+
DrugNEOADJUVANT SETTING
Adjuvant standard treatment for HER2+
DrugADJUVANT SETTING
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: NEOADJUVANT SETTING1 intervention
Group B: ADJUVANT SETTING1 intervention
Trial outcomes
Primary outcomes
1
Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC
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.
Time frame
from baseline to the end of treatment at 12 monthSponsors and contacts
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Source ClinicalTrials.gov