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

Trial Title: Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer with Different HER2 Expression Patterns

NCT ID: NCT06551220

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
Trastuzumab Deruxtecan
HER2

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Retrospective

Summary: 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?

Criteria for eligibility:

Study pop:
This study is a multicenter, retrospective study led by the Sun Yat-sen University Cancer Center. A total of 16 centers are planned to participate in the study, and it aims to include patients with advanced or locally unresectable breast cancer who have received treatment with T-DXd.

Sampling method: Non-Probability Sample
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Start date: October 10, 2022

Completion date: September 2024

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06551220