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

European Institute of Oncology

Status: Enrolling

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

Treatments: Drug: Neoadjuvant standard treatment for HER2+; Drug: Adjuvant standard treatment for HER2+

Study type: Observational

Funder types: Other

Identifiers

NCT06723990

UID 4259

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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;

Trial design

60 participants in 2 patient groups

NEOADJUVANT SETTING

Description:

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

Treatment:

Drug: Neoadjuvant standard treatment for HER2+

ADJUVANT SETTING

Description:

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

Treatment:

Drug: Adjuvant standard treatment for HER2+