Actively Recruiting
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
200
Participants Needed
11
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women defined by age under 50 with regular menstruation or hormonal contraception use with at least one intact ovary, or not postmenopausal by hormone levels
- Women with history of unilateral estrogen receptor positive ductal carcinoma in situ with completed local therapy at least 1 month prior
- Women with recent or prior lobular carcinoma in situ or any epithelial atypia including flat epithelial, atypical ductal hyperplasia, or atypical lobular hyperplasia
- Women eligible for preventive medication based on 5-year risk >= 1.7% or 10-year risk >= 3.4% using validated models
- Women eligible for tamoxifen by ASCO guidelines with increased breast cancer risk
- Women with history of mantle radiotherapy
- Women with moderate penetrance germline pathogenic variants
- Aged 18 to 55 years
- ECOG performance status 0, 1, or 2 (Karnofsky >= 60%)
- HIV-infected women on effective antiretroviral therapy with undetectable viral load in prior 6 months
- Women with chronic hepatitis B infection with undetectable viral load, on suppressive therapy if needed
- Women with treated and cured hepatitis C infection or undetectable viral load if currently on treatment
- Women with herpes simplex virus infection on suppressive antiviral therapy
- Hormonal contraceptive users maintaining the same oral contraceptive during study
- Women of child-bearing potential agreeing to use adequate contraception during study
- Ability to understand and sign informed consent
- Breast Imaging Reporting and Data System (BIRAD) 1 or 2, or BIRAD 0 with follow-up imaging confirming BIRAD 1 or 2
- Women who are factor V Leiden carriers without history of blood clots if approved by physician
You will not qualify if you...
- BIRADS breast density category A on most recent mammogram
- Use of selective estrogen receptor modulators within past 5 years except short or limited recent use under specified conditions
- History of invasive breast cancer
- Prior bilateral mastectomy or breast augmentation including implants; prior excisional biopsy, mastopexy, or mammoplasty allowed if over 1 year ago
- Women with breast size too large for single mammographic screening view
- Current use of strong CYP3A4 inducers or CYP2D6 inhibitors unless able to switch medications
- Current use of Warfarin
- Planning pregnancy within next two years
- History of thromboembolism, pulmonary embolism, thrombotic stroke, arterial thrombosis of extremity, or deep vein thrombosis; superficial thrombophlebitis allowed
- History of uterine cancer or atypical uterine hyperplasia with uterus intact
- Receiving other investigational agents
- History of allergic reactions to compounds similar to tamoxifen
- Uncontrolled illness or psychiatric/social situations limiting compliance
- Pregnant or breastfeeding women
- Women with known mutations in BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53 genes
- Current use of sex hormones unless part of contraception pills
- Prior invasive cancer unless curatively treated and completed over 5 years ago
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of Arizona Cancer Center - Prevention Research Clinic
Tucson, Arizona, United States, 85719
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Illinois College of Medicine - Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
4
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
7
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Actively Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
11
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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