RecruitingPhase 2NCT06184750

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

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


Sponsor

National Cancer Institute (NCI)

Enrollment

200 participants

Start Date

Sep 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This trial (called RENAISSANCE) is trying to find the best low dose of tamoxifen — a hormone-blocking medication — that can reduce breast cancer risk in premenopausal women while causing fewer side effects than the standard full dose. **You may be eligible if...** - You are a premenopausal woman (still having regular periods or on hormonal contraception with at least one ovary) - You are under 50 years of age - You are at increased risk of breast cancer (for example, due to family history, a previous abnormal breast biopsy, or genetic risk factors) - You are not currently pregnant or breastfeeding **You may NOT be eligible if...** - You have already been diagnosed with invasive breast cancer - You have a history of blood clots or stroke - You are currently taking other hormonal treatments that cannot be stopped - You are postmenopausal Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREMammography

Undergo mammography

OTHERQuestionnaire Administration

Ancillary studies

DRUGTamoxifen

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

View Full Details on ClinicalTrials.gov

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NCT06184750


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