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

NCT06184750 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Breast Atypical Ductal Hyperplasia
  • Breast Atypical Lobular Hyperplasia
  • Breast Carcinoma
  • Breast Ductal Carcinoma In Situ
  • Breast Lobular Carcinoma In Situ
  • Estrogen Receptor-Positive Breast Carcinoma

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Seema A Khan · Northwestern University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2028-03-31
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06184750 on ClinicalTrials.gov