Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

238

Participants

Timeline

Start Date

October 21, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2028

Conditions
Premenopausal Breast CancerHormone Receptor-positive Breast Cancer
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.

Trial Locations (1)

03080

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

Seoul National University Hospital

OTHER