drugset / Trial / NCT03664895

Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)

NCT03664895

Phase 3 Unknown 224 enrolled Seoul National University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women * Premise - MMG density as a surrogate marker of hormone therapy * Assumption - "Add on OFS to TMX" would have further decrease of density * 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation

Timeline

Start
2018-09-03
Primary completion
2024-12-02
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Goserelin Other / unclassified
Comparator Leuprolide Other / unclassified