Tamoxifen + Omega-3 for Breast Cancer Risk Reduction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether tamoxifen, with or without omega-3 fatty acids, can lower the risk of breast cancer in postmenopausal women who are overweight or obese. Tamoxifen blocks estrogen in the breast, while omega-3s may help prevent cancer in those carrying extra weight. Participants will be divided into two groups: one will receive tamoxifen alone, and the other will receive tamoxifen combined with omega-3s. The trial seeks postmenopausal women who are overweight or obese and have a higher risk of developing breast cancer, such as those with a family history of the disease or specific genetic markers. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings in breast cancer prevention.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop taking certain medications, such as prescription anticoagulants, daily aspirin (81mg or higher), hormone therapy (except vaginal estrogen), and certain other drugs. If you are on these medications, you may need to discontinue them before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study showed that tamoxifen significantly lowered the risk of invasive breast cancer in women at high risk. Most participants believed the benefits outweighed the risks, though a few disagreed. While tamoxifen is generally safe, it can cause side effects and may not suit everyone.
Research suggests that combining tamoxifen with omega-3 fatty acids is well tolerated. Studies have shown no evidence of harmful effects, making this combination a promising option for reducing breast cancer risk. Omega-3 fatty acids, often found in fish oil, may enhance tamoxifen’s effects by reducing liver-produced fats and possibly blocking cancer growth.
Overall, both treatments appear safe. However, discussing any treatment choice with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining tamoxifen with omega-3 fatty acids for reducing breast cancer risk because it introduces a novel approach to treatment. Typically, tamoxifen is used alone to block estrogen receptors in breast tissue, but adding omega-3s may enhance this effect by reducing inflammation and potentially interfering with cancer cell growth. This combination could offer a dual-action strategy that not only targets estrogen receptors but also leverages the anti-inflammatory and health-boosting properties of omega-3s, making it a promising option for boosting tamoxifen’s effectiveness.
What evidence suggests that this trial's treatments could be effective for reducing breast cancer risk?
Research has shown that tamoxifen, which participants in this trial may receive, can lower the risk of breast cancer, particularly in women with tumors that respond to estrogen. One study found that tamoxifen reduced the risk of invasive breast cancer by 49%. The FDA has approved tamoxifen for preventing breast cancer in women at higher risk. In this trial, one group will receive tamoxifen alone, while another group will receive a combination of tamoxifen and omega-3 fatty acids. Adding omega-3 fatty acids to tamoxifen might enhance its effectiveness in preventing cancer. Some studies suggest that omega-3s could help stop cancer growth, potentially making this combination more effective. Early results indicate that this combination might work well for postmenopausal women who are overweight or obese.45678
Who Is on the Research Team?
Lauren Nye
Principal Investigator
University of Kansas
Are You a Good Fit for This Trial?
This trial is for postmenopausal, overweight or obese women at high risk of developing breast cancer. Participants should not have a history of invasive breast cancer and must be willing to undergo various assessments like mammography and biopsies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive tamoxifen with or without omega-3 fatty acids for 180 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Omega-3 Fatty Acids
- Tamoxifen
Trial Overview
The study is testing if tamoxifen, a drug that blocks estrogen in the breast, can reduce breast cancer risk when taken alone or combined with omega-3 fatty acids, which may prevent cancer by reducing liver fats.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants receive tamoxifen PO QD and omega-3 fatty acids PO BID for 180 days in the absence of unacceptable toxicity. Participants may continue to receive tamoxifen PO QD and omega-3 fatty acids PO BID for up to 60 additional days in the case of scheduling delays. Participants also undergo mammography at screening and undergo RPFNA and collection of blood samples at screening and on study.
Participants receive tamoxifen PO QD for 180 days in the absence of unacceptable toxicity. Participants may continue to receive tamoxifen PO QD for up to 60 additional days in the case of scheduling delays. Participants also undergo mammography at screening and undergo RPFNA and collection of blood samples at screening and on study.
Tamoxifen is already approved in European Union, United States, Canada, Japan for the following indications:
- Breast cancer
- Infertility
- Gynecomastia
- Breast cancer
- Reduction in breast cancer incidence in high-risk women
- McCune-Albright Syndrome
- Breast cancer
- Reduction in breast cancer incidence in high-risk women
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Tamoxifen - StatPearls - NCBI Bookshelf - NIH
This drug is particularly effective for patients with estrogen receptor–positive tumors and is approved by the US Food and Drug Administration ( ...
Low-Dose Tamoxifen Citrate in Reducing Breast Cancer ...
Study Overview. This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors. ...
Tamoxifen for Prevention of Breast Cancer: Report of the ...
Results: Tamoxifen reduced the risk of invasive breast cancer by 49 ... Also self-reported at each visit were data from the Medical Outcomes Study ...
Long-term effects of continuing adjuvant tamoxifen to 10 ...
The risk of recurrence during years 5–14 was 21·4% for women allocated to continue versus 25·1% for controls (absolute recurrence reduction 3·7%); figure 3.
Oral low dose and topical tamoxifen for breast cancer prevention
A trend toward a beneficial effect from low dose tamoxifen in reducing breast cancer events was observed, with greater efficacy being seen in the ER+, PgR+, Ki- ...
NOLVADEX - (Tamoxifen Citrate) - accessdata.fda.gov
For the primary endpoint, the incidence of invasive breast cancer was reduced by 43% among women assigned to NOLVADEX (44 cases - NOLVADEX, 74 ...
Tamoxifen for breast cancer prevention: safety warning
Tamoxifen is not appropriate for breast cancer prevention in women at low risk of the disease (5-year risk less than 1.66%), and discussions about modifiable ...
Tamoxifen: Uses, Side Effects & Risks
The study found that the benefits of tamoxifen outweighed the risks for 74% of their participants, but not for 20% of their participants.
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.