NCT03664895

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

Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Breast Cancer Invasive

Interventions

Type	Name	Description
DRUG	Leuplin or zoladex	OFS(Leuplin or zoladex) add on to TMX

Timeline

• Start date: 2018-09-03
• Primary completion: 2024-12-02
• Completion: 2024-12-31
• First posted: 2018-09-11
• Last updated: 2023-12-04

Locations

1 site across 1 country: South Korea