RecruitingNCT07251868

Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study

Evaluation of Efficacy and Safety of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Multicenter Real-World Study


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

100 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This real-world study collects data from breast cancer patients with brain metastases who have been treated with sacituzumab govitecan (SG), a type of antibody-drug therapy, to understand how well it works and what side effects it causes in this specific group of patients. **You may be eligible if...** - You are 18 or older - You have confirmed breast cancer with brain metastases - You have received sacituzumab govitecan at some point (past or ongoing treatment) - Your medical records are available and traceable - You or your legal guardian can consent and cooperate with follow-up **You may NOT be eligible if...** - You have another active primary cancer (other than breast cancer) diagnosed within the past 5 years - You cannot participate due to mental illness or cognitive impairment without a qualified guardian - You are currently enrolled in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan (SG)

Sacituzumab Govitecan


Locations(1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

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NCT07251868


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