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Evaluation of Efficacy and Safety of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Multicenter Real-World Study
The goal of this real-world study (RWS) is to evaluate the effectiveness of Trop-2 ADC (sacituzumab govitecan) in treating breast cancer patients with brain metastases, and to understand the safety profile of this drug in real clinical practice across multiple centers. The main questions it aims to answer are: Does Trop-2 ADC (sacituzumab govitecan) improve intracranial outcomes in breast cancer patients with brain metastases (e.g., intracranial objective response rate, intracranial progression-free survival)? What types and rates of adverse events do breast cancer patients with brain metastases experience when receiving Trop-2 ADC (sacituzumab govitecan)? This is a multicenter real-world study, which will collect and analyze data from breast cancer patients with brain metastases who have received Trop-2 ADC (sacituzumab govitecan) in routine clinical care (no randomization or placebo control, consistent with real-world clinical scenarios). Participants (breast cancer patients with brain metastases who received Trop-2 ADC) will have their data collected from: Electronic health records (EHRs) across multiple medical centers Regular clinical follow-up visits (e.g., once every 4-8 weeks) for imaging assessments (to evaluate brain metastasis changes) and safety monitoring Medical records documenting treatment responses, disease progression, and any adverse events during treatment and follow-up
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Start Date
August 1, 2024
Primary Completion Date
December 31, 2026
Completion Date
December 31, 2027
Last Updated
November 26, 2025
100
ESTIMATED participants
Sacituzumab Govitecan (SG)
DRUG
Lead Sponsor
Peking University Cancer Hospital & Institute
NCT05673200
NCT04550494
Data Source & Attribution
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