OncoMatch

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 (Sep 2026). This Phase 2 trial studies Tamoxifen for breast atypical ductal hyperplasia.

Phase 2RecruitingNational Cancer Institute (NCI)NCT06184750Data as of Sep 2026

Treatment: TamoxifenThis 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 qualify

Extracted eligibility criteria

Treatments studied

Endocrine / hormonal

Tamoxifen

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 expression

history of unilateral estrogen receptor (ER) positive ductal carcinoma in situ (DCIS)

Excluded: BRCA1 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 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 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 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 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 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 mutation

Women with known gene mutations associated with an increased risk for breast cancer such as BRCA1/2, CDH1, PALB2, PTEN, STK11, or P53

Disease stage

Excluded: Stage INVASIVE BREAST CANCER, PRIOR INVASIVE CANCER ≥ T1 (OTHER THAN NON-MELANOMA SKIN CANCER), UNLESS CURATIVELY TREATED, AND ALL TREATMENT WAS COMPLETED > 5 YEARS PRIOR TO ENROLLMENT

History of invasive breast cancer; Prior invasive cancer ≥ T1 (other than non-melanoma skin cancer), unless curatively treated, and all treatment was completed > 5 years prior to enrollment

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Demographics

Ages ≤ 55
Female only

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 →

Frequently asked questions

Is NCT06184750 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require ESR1?

Yes, ESR1 expression is a required biomarker for enrollment.

Are patients with BRCA1 alterations eligible?

No. BRCA1 mutation is an exclusion criterion.

Are patients with BRCA2 alterations eligible?

No. BRCA2 mutation is an exclusion criterion.

Is there an age limit?

Yes. Patients must be 55 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify