Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns (HEROIC)

Sun Yat-sen University

Status: Enrolling

Conditions: Metastatic Breast Cancer

Treatments: Drug: Trastuzumab Deruxtecan

Study type: Observational

Funder types: Other

Identifiers

NCT06551220

SYSUCC-B2022-617-X01

Details and patient eligibility

About

The purpose of this observational study is to learn about the HER2 heterogeneity and its impact on benefit from trastuzumab deruxtecan in metastatic breast cancer. The main question it aims to answer is:

• Does the heterogeneity of HER2 expression level and spatial distribution in different tissues affect the efficacy of trastuzumab deruxtecan in metastatic breast cancer?

Enrollment: 800 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced or locally unresectable breast cancer;
• Treated with T-DXd (DS-8201, trastuzumab deruxtecan) regardless of line of therapy, HR, and HER2 expression level;
• HER2 immunohistochemistry staining information of the primary lesion or metastatic/recurrent lesion;
• Measurable lesions with treatment response results that can be evaluated through imaging examinations;
• Able to follow up with the latest progression-free survival or overall survival.

Exclusion criteria

• Patients with missing basic clinical information or HER2 immunohistochemistry staining information;
• Patients with missing pathological results for both primary and metastatic/recurrent lesions;
• Patients with no measurable lesions and unable to evaluate T-DXd treatment response;
• Discontinue T-DXd therapy for unacceptable adverse events or other reasons;
• Patients lost to follow-up after T-DXd treatment.

Trial design

800 participants in 1 patient group

Trastuzumab Deruxtecan

Treatment:

Drug: Trastuzumab Deruxtecan