Spots Global Cancer Trial Database for Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)

Study Description

Brief 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

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

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