Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
NCT ID: NCT03664895
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
224 participants
INTERVENTIONAL
2018-09-03
2024-12-31
Brief Summary
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* 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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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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observation arm(TMX, MDR≥5%)
keep go on TMX
No interventions assigned to this group
control arm(TMX, MDR<5%)
keep go on TMX
No interventions assigned to this group
OFS add arm(TMX + OFS, MDR<5%)
OFS add on to TMX
Leuplin or zoladex
OFS(Leuplin or zoladex) add on to TMX
Interventions
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Leuplin or zoladex
OFS(Leuplin or zoladex) add on to TMX
Eligibility Criteria
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Inclusion Criteria
* available MMG density check via Volpara
Exclusion Criteria
* Prior endocrine therapy
* Postmenopausal status
* unavailable MMG density check via volpara before and after TMX
20 Years
45 Years
FEMALE
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Wonshik Han
Role: STUDY_CHAIR
Seoul National University College of Medicine/Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Wonshik Han, MD PhD
Role: primary
Eun-Shin Lee, MD
Role: backup
Other Identifiers
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DELFINO trial
Identifier Type: -
Identifier Source: org_study_id