Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Eligibility
Primary outcome measure(s)
- Changes in Ki-67 level — After 14-day of tamoxifen treatment
Change in Ki67 (percentage of positive tumor cells tested by immunohistochemistry \[IHC\] - digital Image Analysis ) after a 14-day treatment period compared to baseline.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
More Seoul National University Hospital trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04997941 on ClinicalTrials.gov ↗ ← All trials in South Korea