drugset / Trial / NCT03658213

To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.

NCT03658213

Phase 3 Withdrawn AstraZeneca
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

EvaluationDrugModalityDoseRoute
Subject Goserelin Other / unclassified 3.6 mg Subcutaneous
Subject Goserelin Other / unclassified 10.8 mg Subcutaneous

Indications