Acolbifene vs. Low Dose Tamoxifen for Preventing Breast Cancer in Premenopausal Women at High Risk

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05941520

Provider View

This study is comparing two medications, acolbifene and low dose tamoxifen, to see which is better at preventing breast cancer in premenopausal women who are at high risk. The study will look at how these drugs affect breast cancer risk markers in mammograms, breast tissue, and blood samples.

Patient Parameters

Program Overview

This clinical trial is testing whether acolbifene or low dose tamoxifen is more effective in preventing breast cancer in premenopausal women who are at high risk. Women at increased risk often undergo regular breast imaging and may consider preventive surgery. Acolbifene and tamoxifen work by blocking estrogen, which can promote breast cancer growth. The study will measure the effects of these drugs on breast cancer risk markers in mammograms, breast tissue, and blood samples.

Description

The main goal of this study is to see if there is a difference in the change of a specific gene related to breast cancer risk in women taking either acolbifene or low dose tamoxifen for six months. Researchers will also look at how these drugs affect other markers of breast cancer risk, such as mammogram density and quality of life related to menopause symptoms.

Participants will be divided into two groups. One group will take acolbifene daily for six months, while the other group will take tamoxifen daily for the same period. Both groups will have regular mammograms and blood tests, and samples of breast tissue will be collected for analysis.

After completing the treatment, participants will be monitored for any changes in their breast cancer risk markers and overall health. The study aims to provide insights into the effectiveness of these medications in reducing breast cancer risk in high-risk premenopausal women.

Eligibility Criteria

Inclusion Criteria

  • Women aged 35 or older who are premenopausal.
  • Regular menstrual cycles or using a contraceptive device that affects periods.
  • Not planning to become pregnant for at least 12 months.
  • Willing to use effective birth control during the study and for a period after.
  • At high risk for breast cancer due to personal or family history, genetic factors, or other risk assessments.
  • Have at least one breast that has not been treated with radiation or surgery.
  • Good overall health and able to participate in study activities.
  • Willing to sign informed consent and follow study procedures.

Exclusion Criteria

  • Women with breast implants.
  • Pregnant or breastfeeding women.
  • History of invasive breast cancer or other significant cancers in the past five years.
  • Certain genetic mutations that increase cancer risk.
  • Diabetes requiring medication.
  • History of blood clots or stroke.
  • Chronic liver disease or current use of blood thinners.
  • Unable to stop using aspirin or certain hormonal contraceptives before procedures.
  • Previous long-term use of acolbifene or tamoxifen.
  • Allergies to study medications or similar drugs.
  • Uncontrolled health conditions that could interfere with the study.

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