Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
NCT Number: NCT06798506
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.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Shanghai, Shanghai Municipality, 200032, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 6 weeks
Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires
Time frame: 6 weeks
Patient-reported functioning evaluated by QLQ-BR45 questionnaires.
Time frame: 6 weeks
Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE.
Time frame: 6 weeks
Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires.
Time frame: 6 weeks
Progression free survival
Time frame: 6 weeks
Overall Response Rate
Time frame: 6 weeks
Clinical benefit Rates
Time frame: 6 weeks
Overall Survival
Time frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Contact information is provided by the study sponsor or research team.
Fudan University
Other
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 Triple-negative Breast Cancer
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