Real-world Study of UTD1 in Chinese Advanced Breast Cancer
February 23, 2024 updated by: Biyun Wang, MD, Fudan University
An Observational, Real-world Study Study of UTD1 in Chinese Advanced Breast Cancer
To evaluate the efficacy and safety of UTD1 in patients with advanced breast cancer.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
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 Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage
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 UTD1 monotherapy or UTD1 based therapy
- Available medical history.
Exclusion Criteria:
1.Incomplete medical history.
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 |
|---|
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UTD1
UTD1 monotherapy or UTD1 based therapy
|
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 |
|---|---|---|
|
Adverse events
Time Frame: 6 weeks
|
Number of participants with treatment-related adverse events as assessed by CTCAE v 5.0
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 1, 2022
Primary Completion (Actual)
February 1, 2024
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
May 18, 2022
First Submitted That Met QC Criteria
May 18, 2022
First Posted (Actual)
May 23, 2022
Study Record Updates
Last Update Posted (Actual)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 23, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YOUNGBC-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.