Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: TNBC - Triple-Negative Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Patient-reported HRQOL [Time frame: 6 weeks]
Secondary outcome measures (8)
- Patient-reported functioning [Time frame: 6 weeks]
- Patient-reported symptoms [Time frame: 6 weeks]
- Patient-reported tolerability [Time frame: 6 weeks]
- PFS [Time frame: 6 weeks]
- ORR [Time frame: 6 weeks]
- CBR [Time frame: 6 weeks]
- OS [Time frame: 6 weeks]
- Safety [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- Patients aged over 18 years old.
- 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. ER-negative and PgR-negative status was defined as≤1% staining in the nuclei by IHC. 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.
- Patients who have received at least 1 prior regimen in the metastatic setting.
- Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
- Available medical history.
- All patients can provide an informed consent before enrolment and data collection.
Exclusion criteria
- If participating in any controlled clinical trial, the subject cannot take part in this study.
- HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
- Pregnancy and lactation.
- Severe hepatic impairment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT06798506 · YOUNGBC-32