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

Breast Cancer Invasive Clinical Trial

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

Status Recruiting

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 ;

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Neoplasms

• 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