Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
2 other identifiers
observational
312
1 country
1
Brief Summary
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 18, 2016
CompletedFirst Submitted
Initial submission to the registry
July 4, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2018
CompletedResults Posted
Study results publicly available
November 1, 2019
CompletedNovember 1, 2019
October 1, 2019
2.6 years
July 4, 2017
October 9, 2019
October 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Had One or More Adverse Events
Up to Week 24
Secondary Outcomes (1)
Percentage of Participants Who Had One or More Adverse Reactions
Up to Week 24
Study Arms (1)
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.
Interventions
Leuplin PRO for Injection Kit 22.5 mg
Eligibility Criteria
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.
You may qualify if:
- \- Participants with premenopausal breast cancer will be included.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda selected site
Tokyo, Japan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2017
First Posted
July 6, 2017
Study Start
March 18, 2016
Primary Completion
October 10, 2018
Study Completion
October 10, 2018
Last Updated
November 1, 2019
Results First Posted
November 1, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
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.