Actively Recruiting
Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study
Led by Peking University Cancer Hospital & Institute · Updated on 2025-11-26
100
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of Trop-2 ADC in Breast Cancer Patients With Brain Metastases: A Real-World Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of signing the consent form, any gender
- Able to understand the study purpose, risks, and benefits and provide informed consent, or have a legal guardian provide consent if unable
- Have complete medical records including breast cancer diagnosis, brain metastasis diagnosis, treatment with sacituzumab govitecan, and follow-up data
- Diagnosed with breast cancer confirmed by histopathological or cytopathological examination
- Diagnosed with breast cancer brain metastasis confirmed by physician diagnosis with MRI/CT and clinical signs, postoperative pathology, or biopsy
- No restrictions on number, size, meningeal metastasis, or symptoms of brain metastases
- Previous treatment with sacituzumab govitecan documented with medication records, regardless of treatment line, dosage, or cycles
- No restriction on the start time of sacituzumab govitecan treatment; patients currently receiving, completed, or discontinued treatment are eligible
- Stable vital signs without uncontrolled severe infections, recent uncontrolled epileptic seizures, or major organ failure
- Ability to cooperate with study follow-up and provide information on survival, disease progression, treatment, and adverse reactions
You will not qualify if you...
- Other primary malignant tumors active within the past 5 years (excluding breast cancer)
- Unable to cooperate with informed consent or follow-up due to mental illness or cognitive impairment without qualified guardian
- Currently participating in other interventional clinical trials that may affect this study
- Any condition judged by the researcher to affect study quality or patient safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
G
Guohong Song, Doctor of Medicine (M.D.)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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