Evaluation of HER2DX Assay on Treatment Decisions in Patients With Early Stage HER2+ Breast Cancer: the HER2BREASTDX

Recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
• Interventions: Drug: Neoadjuvant standard treatment for HER2+; Drug: Adjuvant standard treatment for HER2+

• Registration Number: NCT06723990
• Lead Sponsor: European Institute of Oncology

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-24
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NEOADJUVANT SETTING	Neoadjuvant standard treatment for HER2+	Neoadjuvant standard treatment for HER2+: A→Tax +T/P
ADJUVANT SETTING	Adjuvant standard treatment for HER2+	Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET)

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Istituto Europeo di Oncologia; 🇮🇹 Milan, Italy