Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Sacituzumab Govitecan

• Registration Number: NCT06356519
• Lead Sponsor: Fudan University

Brief Summary

The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-03-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Patients aged over 18 years old.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. Plan to receive or has received Sacituzumab Govitecan monotherapy
4. Available medical history.

Exclusion Criteria

1. Incomplete medical history.
2. Pregnancy or breast-breeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sacituzumab Govitecan	Sacituzumab Govitecan	Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w

Primary Outcome Measures

Name	Time	Method
PFS	6 weeks	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	6 weeks	Overall Survival
ORR	6 weeks	Overall Response Rate
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	6 weeks	Safety

Trial Locations

Locations (1)

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