Breast Cancer Subjects Clinical Trial
Official title:
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.
The study is to assess the safety, efficacy and pharmacokinetic Behavior of Leuprolide Injectable Emulsion for Premenopausal Breast Cancer Subjects.
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. ;