Actively Recruiting
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
Led by Fudan University · Updated on 2026-04-24
300
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A real-world, multicenter, prospective study to evaluate the patient-reported outcome in Chinese patients who received sacituzumab govitecan or chemotherapy of the physician's choice for metastatic breast cancer progressing on first-line treatment
CONDITIONS
Official Title
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years
- Diagnosed with metastatic HER2-negative breast cancer confirmed by local testing
- Confirmed metastatic disease by clinical, imaging, histological, or cytological methods
- ECOG performance status of 0 to 2
- For TNBC: at least 1 line of systemic therapy in metastatic setting; for HR+/HER2-: prior endocrine therapy, CDK4/6 inhibitors, and at least 1 metastatic systemic therapy
- At least one measurable lesion by CT or MRI per RECIST 1.1
- Willing to accept treatment based on preference, condition, treatment history, and finances
- Willing to use contraceptive methods during the study
- Able and willing to complete electronic questionnaires on a device
- Able to provide informed consent before enrollment and data collection
You will not qualify if you...
- Insufficient bone marrow function: low white blood cells, neutrophils, platelets, or hemoglobin below specified thresholds
- Impaired liver function: high bilirubin or liver enzymes above specified limits
- Impaired kidney function: high creatinine or low creatinine clearance
- History of other cancers or blood cancers
- Allergy to study treatment drugs
- Received systemic anti-tumor therapy within 2 weeks before study drug
- Participated in investigational treatment within 4 weeks before first treatment
- Ongoing toxicity from prior therapy at grade 2 or higher (except hair loss)
- Presence of systemic inflammatory diseases like lupus, arthritis types, Crohn's disease, ulcerative colitis, or active vasculitis
- Severe psychiatric or neurological disorders such as schizophrenia, depression, mania, Alzheimer's, myasthenia gravis, seizure disorders, or seizure-prone conditions
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
B
Biyun Wang Professor
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
2
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