EASOFDIMBCTDS8201 for HER2-positive and HER2-low Metastatic Breast Cancer
Data Collection
Collected from past medical records and data - RetrospectiveCase-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: May 25, 2025
Actual date on which the first participant was enrolled.Breast cancer is a common type of cancer among women, with some cases being more aggressive and harder to treat due to a protein called HER2. This study focuses on a treatment called DS8201, a novel antibody-drug conjugate, which targets HER2 in patients with metastatic breast cancer. The goal is to evaluate its effectiveness and safety in real-world settings, as it has shown promising results in clinical trials. This research is important because it aims to improve treatment options for patients with HER2-positive and HER2-low metastatic breast cancer, who often face poor prognosis and limited therapy choices. In this study, participants will receive DS8201 treatment and their progress will be closely monitored. The primary outcome being measured is progression-free survival (PFS), which is the time it takes for the disease to worsen or for the patient to pass away after starting the treatment. This study also aims to identify factors that may influence the treatment's efficacy, providing valuable insights for clinical application of DS8201.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion criteria: (1) age ≥18 years old; (2) breast cancer confirmed by pathological diagnosis; (3) the presence of one or more distant metastatic lesions confirmed by pathology or imaging; (4) patients had received DS8201 treatment; (5) Complete medical records, complete blood routine and liver and kidney function test results during treatment. Exclusion criteria: no history of traceable or missing clinical data.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The First Hospital of Jilin University
Changchun, ChinaOpen The First Hospital of Jilin University in Google Maps