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RECRUITING
NCT06184750
PHASE2

Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial evaluates response-guided low-dose tamoxifen for reducing breast density in women who are at higher than average risk for breast cancer. Increasing breast density is a well established risk factor for breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen has been shown to reduce breast density, even at reduced dosages, and is approved for the prevention of breast cancer.

Official title: Refining Tamoxifen Dose for Premenopausal Breast Cancer Risk Reduction (RENAISSANCE): A Phase II Single Arm Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2024-09-27

Completion Date

2028-09-30

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

PROCEDURE

Mammography

Undergo mammography

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Tamoxifen

Given PO

Locations (11)

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois College of Medicine - Chicago

Chicago, Illinois, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Case Western Reserve University

Cleveland, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

M D Anderson Cancer Center

Houston, Texas, United States