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

Qualifiers

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 design

Treatments tested in this trial

  • Neoadjuvant standard treatment for HER2+
  • Adjuvant standard treatment for HER2+

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators