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
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
Bone marrow: White blood cell count < 3.0 × 10⁹/L, or absolute neutrophil count < 1.5 × 10⁹/L, or platelet count < 75 × 10⁹/L, or hemoglobin < 8.0 g/dL.
Hepatic function: Total bilirubin > 1.5 × upper limit of normal (ULN), or ALT/AST > 3.0 × ULN (or > 5.0 × ULN in the presence of liver metastases).
Renal function: Serum creatinine > 1.5 × ULN, or creatinine clearance < 50 mL/min.
History of other malignancies or hematologic malignancies.
TNBC
Cohort
Retrospective
Not listed
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
Mean change from baseline in the EORTC QLQ-C30 GHS/QOL score.
Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.
Mean change from baseline in the EORTC QLQ-BR45 score, and time to deterioration.
Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.
Proportion of patients with clinically meaningful improvement or deterioration from baseline in the EORTC QLQ-C30 GHS/QOL score.
Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.
Number and percentage of patients with different severity levels on the PRO-CTCAE at baseline and during follow-up.
PFS
Progression free survival
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