Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Trastuzumab Deruxtecan.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
HER2 Heterogeneity and Its Impact on Benefit From Trastuzumab Deruxtecan in Metastatic Breast Cancer
Overview
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
- Drug Trastuzumab 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.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: 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.]
Secondary outcome measures (1)
- Overall survival (OS) [Time frame: From date of T-DXd treatment initiation until the date of death from any cause, assessed up to 60 months.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 24 centers
- Fujian Cancer Hospital, Fujian Medical University — Fuzhou
- The 10th Affiliated Hospital of Southern Medical University — Dongguan
- The First People's Hospital of Foshan — Foshan
- The Sixth Affiliated Hospital, School of Medicine, South China University of Technology. — Foshan
- Sun Yat-sen University Cancer Center — Guangzhou
- The Affiliated Panyu Central Hospital, Guangzhou Medical University — Guangzhou
- Guangdong Provincial Hospital of Chinese Medicine — Guangzhou
- The Affiliated Cancer Hospital, Guangzhou Medical University — Guangzhou
- … and 16 more centers
United States · 2 centers
- Yale Cancer Center — New Haven
- Dana-Farber Cancer Institute, Harvard Medical School — Boston
Identifiers
NCT: NCT06551220 · SYSUCC-B2022-617-X01