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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab Govitecan cohort | |||
| Chemotherapy of the physician's choice cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported HRQOL | Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported functioning | Patient-reported functioning evaluated by QLQ-BR45 questionnaires. | 6 weeks |
| Patient-reported symptoms | Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biyun Wang, Professor | Contact | +86 13701748410 | pro_wangbiyun@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 6 weeks |
| Patient-reported tolerability | Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires. | 6 weeks |
| PFS | Progression free survival | 6 weeks |
| ORR | Overall Response Rate | 6 weeks |
| CBR | Clinical benefit Rates | 6 weeks |
| OS | Overall Survival | 6 weeks |
| Safety | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |