Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction
Prevention
Phase 2 study for postmenopausal women who are overweight at increased risk for breast cancer
Clinicaltrials.gov identifier:NCT06195306
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: , , , , , , , , or .
Tamoxifen is a selective receptor modulator. It blocks the effects of 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 response, to better understand how these approaches may affect breast cancer risk biology in this group.
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: , , , , , , , , ,
- 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
- 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:
- 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
What the Study Involves
Participants will be into two groups:
- Group 1:
- Low-dose tamoxifen by mouth once daily for 180 days
- 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
- Blood Sample Collection
- Breast biopsy (Periareolar Fine Needle Aspiration)
- Regular follow-up visits to monitor safety and adherence
Participation will last about 6 months.
Study Contact Information:
Contact:
Lauren Nye by phone at 913-588-7791 or email at [email protected]
Locations:
Kansas
City: Kansas City RECRUITING
Facility: University of Kansas Cancer Center
Contact Info:
[email protected]
913-588-7791
Lauren Nye
Michigan
City: Ann Arbor RECRUITING
Facility: University of Michigan Rogel Cancer Center
Contact Info:
[email protected]
734-647-8925
Scott M. Schuetze
Prevention
Phase 2 study for postmenopausal women who are overweight at increased risk for breast cancer
Clinicaltrials.gov identifier:NCT06195306
Study Contact Information:
Contact:
Lauren Nye by phone at 913-588-7791 or email at [email protected]