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

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Goserelin

Criteria

Inclusion Criteria:

• Premenopausal women, ER+ breast cancer, stage I~III, underwent standard treatment including surgery, Planned TMX

• available MMG density check via Volpara

Exclusion Criteria:

• Bilateral breast cancer

• Prior endocrine therapy

• Postmenopausal status

• unavailable MMG density check via volpara before and after TMX