Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer

Not yet recruiting

• Conditions: TNBC - Triple-Negative Breast Cancer

• Registration Number: NCT06798506
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-02-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

1. Patients aged over 18 years old.
2. 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.
3. 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.
4. Patients who have received at least 1 prior regimen in the metastatic setting.
5. Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
6. Available medical history.
7. All patients can provide an informed consent before enrolment and data collection.

Exclusion Criteria

1. If participating in any controlled clinical trial, the subject cannot take part in this study.
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
3. Pregnancy and lactation.
4. Severe hepatic impairment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-reported HRQOL	6 weeks	Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires

Secondary Outcome Measures

Name	Time	Method
Patient-reported functioning	6 weeks	Patient-reported functioning evaluated by QLQ-BR45 questionnaires.
PFS	6 weeks	Progression free survival
Patient-reported symptoms	6 weeks	Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE.
Patient-reported tolerability	6 weeks	Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires.
CBR	6 weeks	Clinical benefit Rates
OS	6 weeks	Overall Survival
ORR	6 weeks	Overall Response Rate
Safety	6 weeks	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China