N/A
Completed N=651
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"
Source: ClinicalTrials.gov NCT02154139 ↗Enrolled (actual)
651
Serious AEs
3.1%
Results posted
Feb 2016
Primary outcomePrimary: Number of Participants Reporting One or More Adverse Drug Reactions — 128 participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting One or More Adverse Drug Reactions |
128 | — |
| PRIMARY Number of Participants Reporting One or More Serious Adverse Drug Reactions |
1 | — |
| SECONDARY Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response) |
10.34; 12.00; 15.00 | — |
| SECONDARY Percentage of Participants With Progression Free Survival |
49.68 | — |
| SECONDARY Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy |
95.37 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02154139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.