Metastatic Breast Cancer
Conditions
Keywords
Breast Cancer, Trastuzumab Deruxtecan, HER2
Brief 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?
Interventions
DRUGTrastuzumab Deruxtecan
The patients received Trastuzumab Deruxtecan at a dose of 5.4 mg/kg every 3 weeks until disease progression or unacceptable adverse effects occurred.
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From date of T-DXd treatment initiation until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 60 months. | Progression-free survival (PFS) is defined as the time from T-DXd treatment initiation to disease progression or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months. | Overall survival (OS) is defined as the time from treatment initiation to death from any cause. |
Countries
China, United States
Contacts
CONTACTXiaoming Xie, MD, PhD
CONTACTYutian Zou, MD, PhD
PRINCIPAL_INVESTIGATORXiaoming Xie, MD, PhD
Sun Yat-Sen University Cancer Center
Outcome results
None listed