Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
Who is this study for? Patients with Breast Cancer
What treatments are being studied? Leuplin or Zoladex
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 45
Healthy Volunteers: f
View:
• Premenopausal women, ER+ breast cancer, stage I\
⁃ III, underwent standard treatment including surgery, Planned TMX
• available MMG density check via Volpara
Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Eun-Shin Lee
silvershoe99@gmail.com
82-2-2072-0173
Time Frame
Start Date: 2018-09-03
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 224
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital