Clinical trial · Observational
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
Leuplin SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprorelin acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- leuprorelin acetate
- description
- Subcutaneous administration of leuprorelin acetate once every 12 weeks
- interventionNames
- Drug: Leuprorelin acetate
Primary outcomes (2)
- measure
- Number of Participants Reporting One or More Adverse Drug Reactions
- timeFrame
- Baseline up to 96 weeks
- description
- Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
- measure
- Number of Participants Reporting One or More Serious Adverse Drug Reactions
- timeFrame
- Baseline up to 96 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Premenopausal breast cancer patients (patients with advanced or recurrent breast cancer and patients who received adjuvant therapy). Exclusion Criteria: * Patients with a history of treatment with Leuplin SR 11.25 mg for Injection
References
Publications (0)
Data not yet available