Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Who Had One or More Adverse Events
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Leuprorelin acetate (Drug)
Outcomes
Primary Outcomes
Percentage of Participants Who Had One or More Adverse Events
Time Frame: Up to Week 24
Secondary Outcomes
- Percentage of Participants Who Had One or More Adverse Reactions(Up to Week 24)