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

NCT03664895 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2023-12-04

No results posted yet for this study

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

Conditions

  • Breast Cancer Invasive

Interventions

DRUG

Leuplin or zoladex

OFS(Leuplin or zoladex) add on to TMX

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Wonshik Han · Seoul National University College of Medicine/Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2024-12-02
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664895 on ClinicalTrials.gov