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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03664895
Collaborator
(none)
224
Enrollment
1
Location
3
Arms
60.9
Anticipated Duration (Months)
3.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Leuplin or zoladex
 Phase 3

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)

  1. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH <30)

  2. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr

  3. MDR ≥5% -> Keep go on TMX MDR <5% -> 1:1 randomization -> Keep go on TMX vs OFS add on to TMX

  4. Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS

  5. 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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 3, 2018
Anticipated Primary Completion Date :
Sep 2, 2023
Anticipated Study Completion Date :
Oct 2, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: observation arm(TMX, MDR≥5%)

keep go on TMX
No Intervention: control arm(TMX, MDR<5%)

keep go on TMX
Active Comparator: OFS add arm(TMX + OFS, MDR<5%)

OFS add on to TMX

Drug: Leuplin or zoladex
OFS(Leuplin or zoladex) add on to TMX

Outcome Measures

Primary Outcome Measures

  1. MMG density Reduction [5 years]

Secondary Outcome Measures

  1. Disease free survival [5 years]

Other Outcome Measures

  1. overall survival [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 110-744

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

  • Study Chair: Wonshik Han, Seoul National University College of Medicine/Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT03664895
Other Study ID Numbers:
  • DELFINO trial
First Posted:
Sep 11, 2018
Last Update Posted:
Sep 11, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seoul National University Hospital
premenopausal women, MMG density, Ovary function suppression
Additional relevant MeSH terms:
Breast Neoplasms
Goserelin

Study Results

No Results Posted as of Sep 11, 2018