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

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a genomic test called HER2DX can help doctors make better treatment decisions for patients with early-stage HER2-positive breast cancer — specifically, whether it can identify who may safely receive less treatment. **You may be eligible if...** - Age 18 or older - Diagnosed with HER2-positive breast cancer confirmed by biopsy - Have Stage I, II, or III breast cancer (no distant spread) - Being considered for chemotherapy or hormone therapy before or after surgery - Have provided written consent **You may NOT be eligible if...** - Cancer has spread to distant organs (metastatic) - Do not have HER2-positive breast cancer - Previously received treatment for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant standard treatment for HER2+

NEOADJUVANT SETTING

DRUGAdjuvant standard treatment for HER2+

ADJUVANT SETTING


Locations(1)

Istituto Europeo di Oncologia

Milan, Italy, Italy

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NCT06723990


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