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Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients
Sponsor: Seoul National University Hospital
Summary
MORE-T trial is designed to investigate the effect of Tamoxifen 40mg (vs. Tamoxifen 20mg) for 2wks in presurgical setting. The greater reduction in Ki-67 might be observed in Tamoxifen 40mg arm compared to the Tamoxifen 20mg arm. Open Label, Phase 2, Randomized with 1:1 allocation
Official title: Higher Dose taMOxifen in Premenopausal bREast Cancer Patients: a preoperaTive Window Trial (MORE-T Trial)
Key Details
Gender
FEMALE
Age Range
20 Years - 48 Years
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2021-10-21
Completion Date
2028-12-31
Last Updated
2024-04-23
Healthy Volunteers
Yes
Interventions
Tamoxifen Oral Product
Experimental arm will have tamoxifen 40mg and active comparator arm will have tamoxifen 20mg for 14 days.
Assessment of Ki-67
Paired biopsies (before and after tamoxifen therapy) will be required for the assessment of Ki-67.
Surgery
The surgery date should be fixed before randomization. The surgery is to be performed within 1 day after the last dose of study treatment.
Locations (1)
Seoul National University Hospital
Seoul, South Korea