Overview
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
Description
Enroll : Sep03,2018~(Planned N= 224)
- 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)
- Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30)
- MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
- MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX
- Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
- 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
Eligibility
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