The aim of this trial is to explore the real-world patient-reported health-related quality of life (HRQOL), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for Chinese mTNBC patients. Evaluation of HRQOL and functioning using the EORTC QLQ-C30 and QLQ-BR45 questionnaires, including change from baseline and time to deterioration in each scale or item. Treatment-related symptoms and tolerability were assessed using the Patient-Reported Outcomes of the PRO-CTCAE and PGI-TT questionnaires.
Study Type
OBSERVATIONAL
Enrollment
300
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Patient-reported HRQOL
Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires
Time frame: 6 weeks
Patient-reported functioning
Patient-reported functioning evaluated by QLQ-BR45 questionnaires.
Time frame: 6 weeks
Patient-reported symptoms
Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE.
Time frame: 6 weeks
Patient-reported tolerability
Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires.
Time frame: 6 weeks
PFS
Progression free survival
Time frame: 6 weeks
ORR
Overall Response Rate
Time frame: 6 weeks
CBR
Clinical benefit Rates
Time frame: 6 weeks
OS
Overall Survival
Time frame: 6 weeks
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 6 weeks
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