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Higher Dose Preoperative taMOxifen in Premenopausal bREast Cancer Patients

NCT04997941 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2024-04-23

No results posted yet for this 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

Conditions

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.

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hyeong-Gon Moon · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-21
Primary Completion
2024-12-31
Completion
2028-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997941 on ClinicalTrials.gov