Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction
https://www.facingourrisk.org/research-clinical-trials/study/395 /low-dose-tamoxifen-with-or-without-omega-3-fatty-acids-for-breast-cancer-risk-reduction
Clinicaltrials.gov identifier:
NCT06195306 (https://clinicaltrials.gov/show/NCT06195306)
Prevention
Phase 2 study for postmenopausal women who are overweight at increased risk for breast cancer
Study Contact Information:
Contact:
Lauren Nye by phone at 913-588-7791 or email at [email protected]
About the Study
This phase II study looks at whether low-dose tamoxifen works differently when it is taken with high-dose omega-3 fatty acids (a type of fish-oil supplement) in postmenopausal women who are overweight or obese and at increased risk for breast cancer or who have a genetic mutation in the following genes: ATM, BARD1, CDH1, CHEK2, NF1, PALB2, PTEN, RAD51C, RAD51D or STK11.
Tamoxifen is a selective estrogen receptor modulator. It blocks the effects of estrogen in breast tissue and is FDA-approved to help lower breast cancer risk in some women at increased risk. Omega-3 fatty acids may affect how the body processes fats and may have different effects in people who are overweight or obese.
Researchers will compare low-dose tamoxifen alone versus low-dose tamoxifen plus omega-3 fatty acids over about 6 months. The study focuses on changes in blood and breast-tissue markers that are linked with metabolism and estrogen response, to better understand how these approaches may affect breast cancer risk biology in this group.
What the Study Involves
Participants will be randomized into two groups:
- Group 1:
- Low-dose tamoxifen by mouth once daily for 180 days
- Mammography
- Blood Sample Collection
- Breast biopsy (Periareolar Fine Needle Aspiration)
- Regular follow-up visits to monitor safety and adherence
- Group 2:
- Low-dose tamoxifen plus omega-3 fatty acids by mouth once daily for 180 days
- Mammography
- Blood Sample Collection
- Breast biopsy (Periareolar Fine Needle Aspiration)
- Regular follow-up visits to monitor safety and adherence
Participation will last about 6 months.
This Study is Open To:
Women who are between the ages of 45-74 and meet the following criteria:
- Gone through Menopause
- Overweight or obese (BMI ≥ 25)
- At increased risk of Breast Cancer due to at least one of the following risk factors:
- History of abnormal breast tissue (atypical hyperplasia, lobular carcinoma in situ, ductal carcinoma in situ)
- Dense breast tissue
- Genetic mutation in the following genes: ATM, BARD1, CDH1, CHEK2, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11
- Family history of breast cancer that includes any of the following:
- Breast cancer before age of 50
- Two of more first or second-degree relatives with breast cancer
- Bilateral Breast cancer
- Ovarian Cancer
- Healthy enough to take study medications without any other complications from other medications/conditions
This Study is Not Open To:
People who have:
- Had previous breast or uterine cancer
- Previous invasive cancer that is still active
- Currently breastfeeding
- Diabetes type I or II
- Genetic mutation in following genes:
- BRCA1
- TP53
- Previous history of stroke or chronic liver disease
- Currently on medications that may interfere with study medications such as the following:
- Blood thinners
- Aspirin
- Hormone therapy
- Immunosuppressive drugs/medications that inhibit or reduce the strength of the body’s immune system
- Metformin
- Allergic to Tamoxifen or Omega-3 Fatty Acids
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.