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Clinical Trial 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


Clinical Trial Description

Enroll : Sep03,2018~(Planned N= 224) 1. Inclusion criteria - Premenopausal - ER+ - Planned tamoxifen(TMX) - No planned ovary function suppression(OFS) - Regardless of ChemoTx - Mammography(MMG) density check via Volpara*(=Baseline MMG density, BaMD) (*Volpara= software to check MMG density) 2. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30) 3. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr 4. MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX 5. Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS 6. Calculation of patients' number In previous study(<Kim et al. Breast Can Res 2012>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy. Expected - MDR in "TMX only" cohort -> 6 ± 7% - MDR in "OFS add on to TMX" -> 10 ± 7% - after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate => 1:1 randomization Number = 112(56:56) Total number = 224 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03664895
Study type Interventional
Source Seoul National University Hospital
Contact Eun-Shin Lee
Phone 82-2-2072-0173
Email silvershoe99@gmail.com
Status Recruiting
Phase Phase 3
Start date September 3, 2018
Completion date December 31, 2024

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