NCT03664895

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

6.3 years

First QC Date

September 7, 2018

Last Update Submit

November 30, 2023

Conditions

Breast Cancer Invasive

Keywords

premenopausal women, MMG density, Ovary function suppression

Outcome Measures

Primary Outcomes (1)

  • MMG density Reduction

    5 years

Secondary Outcomes (1)

  • Disease free survival

    5 years

Other Outcomes (1)

  • overall survival

    5 years

Study Arms (3)

observation arm(TMX, MDR≥5%)

NO INTERVENTION

keep go on TMX

control arm(TMX, MDR<5%)

NO INTERVENTION

keep go on TMX

OFS add arm(TMX + OFS, MDR<5%)

ACTIVE COMPARATOR

OFS add on to TMX

Drug: Leuplin or zoladex

Interventions

Leuplin or zoladexDRUG

OFS(Leuplin or zoladex) add on to TMX

OFS add arm(TMX + OFS, MDR<5%)

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal women, ER+ breast cancer, stage I\~III, underwent standard treatment including surgery, Planned TMX
  • available MMG density check via Volpara

You may not qualify if:

  • Bilateral breast cancer
  • Prior endocrine therapy
  • Postmenopausal status
  • unavailable MMG density check via volpara before and after TMX

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Interventions

LeuprolideGoserelin

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Wonshik Han

    Seoul National University College of Medicine/Seoul National University Hospital

    STUDY CHAIR

Central Study Contacts

Eun-Shin Lee

CONTACT

82-2-2072-0173silvershoe99@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 11, 2018

Study Start

September 3, 2018

Primary Completion

December 2, 2024

Study Completion

December 31, 2024

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations

KR(1)