Clinical trial · Interventional
Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
A Phase III, Multicenter, Randomized, Open-Label Study to Assess the Safety, Efficacy and Pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
NCT06449027CI-TRIAL-00096046active not recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
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 Subjects | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprorelin Acetate Microspheres for Injection | Drug | — | UNRESOLVED |
| T Leuprolide Injectable Emulsion | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Leuprolide Injectable Emulsion
- description
- 100 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks.
- interventionNames
- Drug: T Leuprolide Injectable Emulsion
- type
- ACTIVE_COMPARATOR
- label
- Leuprorelin Acetate Microspheres for Injection
- description
- 100 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks.
- interventionNames
- Drug: Leuprorelin Acetate Microspheres for Injection
Primary outcomes (1)
- measure
- Observe the proportion of subjects whose E2 levels remain at postmenopausal levels between 4 and 48 weeks after treatment, to assess the Efficacy of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subject.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal female subjects aged 18 to 55 years old. * Histological or cytological confirmation of HR+，HER2- premenopausal breast cancer. * Subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery. * Life expectancy is not less than 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate function of major organs. Exclusion Criteria: * History of evidence of distant metastatic lesions; * Subjects have the history of new adjuvant or adjuvant endocrine treatment for breast cancer ( Excluding subjects receiving tamoxifen citrate tablets treatment for less than 12 weeks before informing). * Active hepatitis B, hepatitis C or HIV in screening.
References
Publications (0)
Data not yet available
No reference posted for this study.