Breast Cancer Subjects
Conditions
Brief summary
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
Detailed description
This is a multicenter, randomized, open-Label , non-inferiority phase III study . All premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio. Furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study. The efficacy of maintaining serum E2 levels ≤30 pg/mL at 4-48 weeks post-treatment will be assessed in both groups.
Interventions
DRUGT Leuprolide Injectable Emulsion
Arm 1 subjects were injected Leuprolide Injectable Emulsion 42mg every 24 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.
DRUGLeuprorelin Acetate Microspheres for Injection
Arm 2 subjects were injected Leuprorelin Acetate Microspheres for Injection 11.25mg every 12 weeks for 48 weeks, and taked Tamoxifen Citrate Tablets 10mg bid for 48 weeks.
Sponsors
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Observe the concentration of LH, FSH, E2 after treatment. | 48 weeks |
| Pharmacokinetic Parameter(AUC) | 48 weeks |
| Pharmacokinetic Parameter(Cmax) | 48 weeks |
Countries
China
Outcome results
None listed