Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer (NCT07551050) | Clinical Trial Compass
RecruitingNot Applicable
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
China300 participantsStarted 2026-05-15
Plain-language summary
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
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Patients aged 18 to 75 years.
✓. Patients have been diagnosed with metastatic HER2 negative breast cancer. HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio \<2.0 if IHC 2+ or IHC not performed.
✓. The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
✓. ECOG-PS ≤2
✓. For patients with triple-negative breast cancer (TNBC): at least 1 line of systemic therapy in the metastatic setting; for patients with HR+/HER2- breast cancer: prior treatment with endocrine therapy and CDK4/6 inhibitors, and at least 1 line of systemic therapy in the metastatic setting.
✓. At least one evaluable lesion by CT or MRI according to RECIST 1.1.
✓. Willing to accept the treatment by the investigator based on the patient's preference, physical condition, prior treatment history, and financial circumstances.
✓. Willing to use contraceptive measures during the study period.
Exclusion criteria
✕. Insufficient bone marrow, hepatic, or renal function, defined as:
✕. History of other malignancies or hematologic malignancies.
What they're measuring
1
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
✕. Systemic anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, etc.) within 2 weeks prior to study drug administration.
✕. Treatment with an investigational product within 4 weeks before the first treatment.
✕. Presence of any toxicity from prior therapy (excluding alopecia) ≥ Grade 2 according to CTCAE version 5.0, prior to study drug administration.
✕. Systemic inflammatory diseases, including but not limited to systemic lupus erythematosus, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or active vasculitis.
✕. Severe psychiatric or neurological disorders, including but not limited to schizophrenia, depression, mania, Alzheimer's disease, myasthenia gravis, seizure disorders, or known conditions that may provoke seizures.