NCT07551050 Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
| NCT ID | NCT07551050 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | TNBC - Triple-Negative Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2029-04-15 |
Trial Parameters
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Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 75 years. 2. 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. 3. 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. 4. ECOG-PS ≤2 5. 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. 6. At least one evaluable lesion by CT or MRI according to RECIST 1.1. 7. Will
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