Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
- Registration Number
- NCT03209518
- Lead Sponsor
- Takeda
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 312
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Leuprorelin acetate 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Had One or More Adverse Events Up to Week 24
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Had One or More Adverse Reactions Up to Week 24 Adverse drug reaction refers to adverse events related to the administered drug.
Trial Locations
- Locations (1)
Takeda selected site
🇯🇵Tokyo, Japan