Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant standard treatment for HER2+, Adjuvant standard treatment for HER2+.
- Who it may be relevant to
- Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Neoadjuvant standard treatment for HER2+
NEOADJUVANT SETTING - Drug Adjuvant standard treatment for HER2+
ADJUVANT SETTING
Primary outcome measures
- Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC [Time frame: from baseline to the end of treatment at 12 month]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Europeo di Oncologia — Milan
Identifiers
NCT: NCT06723990 · UID 4259