Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
October 9, 2019 updated by: Takeda
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.
This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.
The survey will enroll approximately 300 patients.
- Leuprorelin
This multi-center survey will be conducted in Japan.
Study Type
Observational
Enrollment (Actual)
312
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
-
-
-
Tokyo, Japan
- Takeda Selected Site
-
-
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
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The survey population will consist of participants with a diagnosis of premenopausal breast cancer and received dose of Leuprorelin for Injection Kit 22.5 mg in the routine medical care.
Description
Inclusion Criteria:
- Participants with premenopausal breast cancer will be included.
Exclusion Criteria:
- Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
- Pregnant or potentially pregnant participants and breastfeeding participants
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 |
|---|---|
|
Leuprorelin acetate
Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks.
Refer to the Precautions section of the package insert.
Participants received Leuprorelin as part of routine medical care.
|
Leuplin PRO for Injection Kit 22.5 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Participants Who Had One or More Adverse Events
Time Frame: Up to Week 24
|
Up to Week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants Who Had One or More Adverse Reactions
Time Frame: Up to Week 24
|
Adverse drug reaction refers to adverse events related to the administered drug.
|
Up to Week 24
|
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)
March 18, 2016
Primary Completion (ACTUAL)
October 10, 2018
Study Completion (ACTUAL)
October 10, 2018
Study Registration Dates
First Submitted
July 4, 2017
First Submitted That Met QC Criteria
July 4, 2017
First Posted (ACTUAL)
July 6, 2017
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 9, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Leuprorelin-5003
- JapicCTI-163203 (REGISTRY: JapicCTI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com
for details).
To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias.
Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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.