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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Breast Cancer Invasive

Intervention / Treatment
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* Drug: Leuplin or zoladex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: observation arm(TMX, MDR≥5%)<br>keep go on TMX | |
| No Intervention: control arm(TMX, MDR<5%)<br>keep go on TMX | |
| Active Comparator: OFS add arm(TMX + OFS, MDR<5%)<br>OFS add on to TMX | Drug: Leuplin or zoladex<br>* OFS(Leuplin or zoladex) add on to TMX<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MMG density Reduction |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premenopausal women, MMG density, Ovary function suppression