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ACTIVE NOT RECRUITING
NCT04997941
PHASE2

Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

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

DRUG

Tamoxifen Oral Product

Experimental arm will have tamoxifen 40mg and active comparator arm will have tamoxifen 20mg for 14 days.

DIAGNOSTIC_TEST

Assessment of Ki-67

Paired biopsies (before and after tamoxifen therapy) will be required for the assessment of Ki-67.

PROCEDURE

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