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NCT06356519 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
Effectiveness and Safety of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer: A Multi-center Real-world Retrospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06356519
Other study ID # YOUNGBC-29
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 1, 2024
Est. completion date April 1, 2025

Study information
Verified date April 2024
Source Fudan University
Contact Biyun Wang, Professor
Phone +8613701748410
Email pro_wangbiyun@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date April 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Sacituzumab Govitecan
Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w

Locations
Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary PFS Progression free survival 6 weeks
Secondary ORR Overall Response Rate 6 weeks
Secondary OS Overall Survival 6 weeks
Secondary Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Safety 6 weeks
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