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

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ClinicalTrials.gov Identifier: NCT03664895
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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
Breast Cancer Invasive 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)
  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  (Clinical Trial)
Estimated 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 : September 3, 2018
Estimated Primary Completion Date : September 2, 2023
Estimated Study Completion Date : October 2, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. MMG density Reduction [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]

Other Outcome Measures:
  1. overall survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664895


Contacts
Contact: Eun-Shin Lee 82-2-2072-0173 silvershoe99@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Wonshik Han, MD PhD    82-2-2072-1958    hanw@snu.ac.kr   
Contact: Eun-Shin Lee, MD       silvershoe99@gmail.com   
Principal Investigator: Eun-Shin Lee, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Wonshik Han Seoul National University College of Medicine/Seoul National University Hospital

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03664895     History of Changes
Other Study ID Numbers: DELFINO trial
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Goserelin
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs