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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06723990

Acronym

HER2BREASTDX

Enrollment

Registered

2024-12-09

Start date

2024-10-24

Completion date

2027-11-01

Last updated

2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Keywords

HER2 positive breast cancer patients with stage I-III

Brief 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.

Interventions

DRUGNeoadjuvant standard treatment for HER2+

NEOADJUVANT SETTING

DRUGAdjuvant standard treatment for HER2+

ADJUVANT SETTING

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame	Description
Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC	from baseline to the end of treatment at 12 month	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.

Countries

Italy

Contacts

CONTACTPaola Zagami

paola.zagami@ieo.it00390294372437

PRINCIPAL_INVESTIGATORPaola Zagami

Istituto Europeo di Oncologia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026