- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06356519
Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer
April 4, 2024 updated by: Biyun Wang, MD, Fudan University
Effectiveness and Safety of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer: A Multi-center Real-world Retrospective Study
The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.
Study Overview
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Biyun Wang, Professor
- Phone Number: +8613701748410
- Email: pro_wangbiyun@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
-
Contact:
- Biyun Wang
- Phone Number: 18017312387
- Email: pro_wangbiyun@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients aged over 18 years old with metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
Description
Inclusion Criteria:
- Patients aged over 18 years old.
- Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- Plan to receive or has received Sacituzumab Govitecan monotherapy
- Available medical history.
Exclusion Criteria:
- Incomplete medical history.
- Pregnancy or breast-breeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Sacituzumab Govitecan
Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w
|
Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 6 weeks
|
Progression free survival
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 6 weeks
|
Overall Response Rate
|
6 weeks
|
OS
Time Frame: 6 weeks
|
Overall Survival
|
6 weeks
|
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 6 weeks
|
Safety
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Biyun Wang, Professor, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2024
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
April 4, 2024
First Submitted That Met QC Criteria
April 4, 2024
First Posted (Actual)
April 10, 2024
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 4, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YOUNGBC-29
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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