Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant standard treatment for HER2+ | Drug | — | UNRESOLVED |
| Neoadjuvant standard treatment for HER2+ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- NEOADJUVANT SETTING
- description
- Neoadjuvant standard treatment for HER2+: A→Tax +T/P
- interventionNames
- Drug: Neoadjuvant standard treatment for HER2+
- label
- ADJUVANT SETTING
- description
- Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET)
- interventionNames
- Drug: Adjuvant standard treatment for HER2+
Primary outcomes (1)
- measure
- Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC
- timeFrame
- from baseline to the end of treatment at 12 month
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available