OncoMatch/Clinical Trials/NCT06184750
Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial
Is NCT06184750 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Tamoxifen for breast atypical ductal hyperplasia.
Treatment: Tamoxifen — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (estrogen receptor positive)
A history of unilateral estrogen receptor (ER) positive ductal carcinoma in situ (DCIS)
Excluded: BRCA1 pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Excluded: BRCA2 pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Excluded: CDH1 pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Excluded: PALB2 pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Excluded: PTEN pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Excluded: STK11 pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Excluded: TP53 pathogenic mutation
Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: selective estrogen receptor modulator
Exception: Use was less than 6 months duration in the past 5 years and not used in the 1 year prior to enrollment OR use was no greater than 2 months duration in the past 1 year and not used in the 6 months prior to enrollment
History of selective estrogen receptor modulator (SERM) use within the past 5 years unless: Use was less than 6 months duration in the past 5 years and not used in the 1 year prior to enrollment OR Use was no greater than 2 months duration in the past 1 year and not used in the 6 months prior to enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Arizona Cancer Center - Prevention Research Clinic · Tucson, Arizona
- Northwestern University · Chicago, Illinois
- University of Illinois College of Medicine - Chicago · Chicago, Illinois
- University of Kansas Cancer Center · Kansas City, Kansas
- Brigham and Women's Hospital · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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