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

NCT06723990 | Recruiting DMC

• 1 other identifier: UID 4259
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HER2 positive breast cancer patients with stage I-III

Outcome Measures

Primary Outcomes (1)

• Impact of HER2DX on the decision-making processes of the treating physicians and multidisciplinary tumour board, in patients with stage I-III HER2+ BC

  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.

  from baseline to the end of treatment at 12 month

Study Arms (2)

NEOADJUVANT SETTING

Neoadjuvant standard treatment for HER2+: A→Tax +T/P

Drug: Neoadjuvant standard treatment for HER2+

ADJUVANT SETTING

Adjuvant standard treatment for HER2+ (N0): Tax + T (+/-ET); Adjuvant standard treatment for HER2+ (N+): A→Tax +T/P (+/- ET)

Drug: Adjuvant standard treatment for HER2+

Interventions

Neoadjuvant standard treatment for HER2+ DRUG

NEOADJUVANT SETTING

NEOADJUVANT SETTING

Adjuvant standard treatment for HER2+ DRUG

ADJUVANT SETTING

ADJUVANT SETTING

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER2 positive breast cancer patients with stage I-III

You may qualify if:

• 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);

You may not qualify if:

• HER2- BC;
• Stage IV breast cancer;
• Lack of informed consent because of patient's incapable of discernment or unwilling to participate;

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

Istituto Europeo di Oncologia

Milan, Italy, Italy

RECRUITING

Study Officials

• Paola Zagami

  Istituto Europeo di Oncologia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Zagami

CONTACT

00390294372437; paola.zagami@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 9, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

IT (1)