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

November 30, 2023 updated by: Seoul National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

224

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Wonshik Han, MD PhD
          • Phone Number: 82-2-2072-1958
          • Email: hanw@snu.ac.kr
        • Contact:
        • Principal Investigator:
          • Eun-Shin Lee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MMG density Reduction
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease free survival
Time Frame: 5 years
5 years

Other Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2018

Primary Completion (Estimated)

December 2, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 7, 2018

First Submitted That Met QC Criteria

September 7, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DELFINO trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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