Finding the Best Tamoxifen Dose for Reducing Breast Cancer Risk in Premenopausal Women: RENAISSANCE Trial

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06184750

Provider View

This study is testing different doses of tamoxifen to see if it can reduce breast density, a risk factor for breast cancer, in premenopausal women at higher risk. Tamoxifen blocks estrogen in the breast and may help lower breast cancer risk.

Patient Parameters

Program Overview

This trial is exploring if low-dose tamoxifen can reduce breast density in women at higher risk for breast cancer. Breast density is a known risk factor for breast cancer. Tamoxifen, a drug that blocks estrogen in the breast, has been shown to reduce breast density even at lower doses and is approved for breast cancer prevention.

Description

The main goal of this study is to see if increasing the dose of tamoxifen from 5 mg to 10 mg per day can help more premenopausal women reduce their breast density by more than 10% on a mammogram.

Other goals include:

  • Checking if blood levels of tamoxifen and its breakdown products relate to changes in breast density.
  • Monitoring changes in certain blood markers related to tamoxifen at different doses.
  • Seeing if starting breast density affects how well tamoxifen works.
  • Evaluating how different doses of tamoxifen affect symptoms reported by participants.
  • Assessing how different doses affect participants' adherence to the treatment.

The study will also explore:

  • Changes in breast tissue markers in response to tamoxifen.
  • Genetic factors that might influence breast cancer risk and tamoxifen metabolism.
  • Changes in breast cancer risk estimates over 18 months using an AI tool.

Participants will start with 5 mg of tamoxifen daily for 6 months. If their breast density reduces by 10% or more, they will continue with the same dose for another 12 months. If not, the dose will be increased to 10 mg daily for 6 months. If breast density still doesn't reduce by 10% after 6 months on 10 mg, participants can choose to continue with 10 mg or increase to 20 mg daily for another 6 months. Participants will have mammograms and blood tests during the study and may have optional biopsies. Follow-up will occur 4 weeks after completing the study treatment.

Eligibility Criteria

Inclusion Criteria

  • Premenopausal women under 50 with regular periods or using hormonal contraception with at least one ovary.
  • Women not postmenopausal based on hormone levels.
  • Women with a history of certain breast conditions or at higher risk for breast cancer based on specific criteria.
  • Women aged 18 to 55.
  • Good overall health with a performance status of 0 to 2.
  • HIV-positive women on effective treatment with undetectable viral load.
  • Women with controlled hepatitis B or C, or herpes simplex virus.
  • Women using hormonal contraceptives must maintain the same type during the trial.
  • Women of childbearing potential must use effective contraception during the study.
  • Ability to understand and sign informed consent.

Exclusion Criteria

  • Very low breast density on recent mammogram.
  • Use of similar drugs to tamoxifen in the past 5 years for more than 1 year.
  • History of invasive breast cancer.
  • Previous major breast surgery.
  • Large breast size that cannot be imaged in one mammogram view.
  • Use of certain medications unless willing to switch.
  • Planning pregnancy in the next two years.
  • History of blood clots, except superficial ones.
  • History of uterine cancer or certain uterine conditions.
  • Participation in other investigational studies.
  • Allergies to tamoxifen or similar drugs.
  • Uncontrolled illnesses or psychiatric conditions affecting study compliance.
  • Pregnant or breastfeeding women.

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