drugset / Trial / NCT03658213
To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will recruit 168 patients in approximately 20 study centres in China. The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.
Timeline
- Start
- 2020-03-31
- Primary completion
- 2021-11-04
- Completion
- 2021-11-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goserelin | Other / unclassified | 3.6 mg | Subcutaneous |
| Subject | Goserelin | Other / unclassified | 10.8 mg | Subcutaneous |