- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04541420
Eribulin in mTNBC Patients
February 2, 2021 updated by: Biyun Wang, MD, Fudan University
An Observational, Retrospective Study of Eribulin in Advanced Breast Cancer
To evaluate the efficacy and safety of Eribulin in patients with advanced breast cancer.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
208
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
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with breast cancer (according to International Classification of Diseases-10, ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.
Description
Inclusion Criteria:
- Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- Eribulin treatment of advanced breast cancer for at least one cycle, between Dec 2019 and Aug 2020.
- 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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
---|
Eribulin
Eribulin 1.4mg/m2 d1,8 iv 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
|
Adverse events
Time Frame: 6 weeks
|
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
|
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)
December 15, 2019
Primary Completion (Actual)
December 15, 2020
Study Completion (Actual)
December 20, 2020
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
September 2, 2020
First Posted (Actual)
September 9, 2020
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
February 2, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YOUNGBC-12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Shared information is not allowed by study cencer.
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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