Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction (NCT06195306) | Clinical Trial Compass
RecruitingPhase 2
Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction
United States66 participantsStarted 2025-07-28
Plain-language summary
This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.
Who can participate
Age range45 Years – 74 Years
SexFEMALE
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Inclusion Criteria:
* Age 45 - 74
* Postmenopausal female
* Postmenopausal is defined as either
* Prior removal of the ovaries, or if ovaries intact amenorrhea for \>= 12 months and not on any form of contraception, or
* Amenorrhea for greater than 2 months with serum follicle-stimulating hormone (FSH) in postmenopausal range (\>= 25 IU/L). Women with ovaries and a prior hysterectomy or endometrial ablation \< age 55 must have a FSH \>= 25 IU/L. Women may be on vaginal low dose estrogen preparations for vaginal dryness. Women over age 50 with a levonorgestrel intrauterine device in place for 2 or more years and not planning removal in the next 6 month are also eligible if FSH \>= 25 IU/L
* Note: FSH will be done at time of screening
* Women with intact ovaries and uterus \< age 55 must have a negative pregnancy test prior to randomization
* Overweight or obese (body mass index \[BMI\] \>= 25 kg/m\^2)
* Note: BMI must be calculated within 28 days of randomization
* Willing to undergo a fasting blood draw and non-fasting RPFNA with fixed and frozen aliquots sent to University of Kansas Medical Center (KUMC)
* At increased risk of breast cancer per at least one of the following:
* Personal medical history
* History of atypical hyperplasia or lobular carcinoma in situ (LCIS) found on breast biopsy
* History of unilateral ductal carcinoma in situ treated with unilateral mastectomy, lumpectomy, or local excision with or without radiation and this …
What they're measuring
1
Change in serum adiponectin
Timeframe: From baseline up to end of treatment (6 months)