Tamoxifen + Omega-3 for Breast Cancer Risk Reduction

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Anticoagulants, Aspirin, Hormone therapy, others

Disqualifiers: Diabetes, Breastfeeding, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 26 weeks

66 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug combination of Tamoxifen and Omega-3 for reducing breast cancer risk?

Research suggests that combining Tamoxifen with Omega-3 fatty acids may enhance the drug's ability to prevent breast cancer by working together to block cancer growth pathways. This combination might also allow for lower doses of Tamoxifen, potentially reducing side effects. ^{1 2 3 4 5}

Is the combination of Tamoxifen and Omega-3 fatty acids safe for humans?

Research suggests that the combination of Tamoxifen and Omega-3 fatty acids is well tolerated and shows no evidence of toxicity in studies, indicating it is generally safe for humans. ^{1 2 3 4 6}

How is the drug Tamoxifen combined with Omega-3 unique for breast cancer prevention?

The combination of Tamoxifen with Omega-3 fatty acids is unique because it potentially enhances the antitumor effects of Tamoxifen by targeting multiple pathways, allowing for lower doses of Tamoxifen, which may reduce side effects. This combination may offer a more effective and safer approach to breast cancer prevention compared to Tamoxifen alone. ^{1 3 4 5 6}

What is the purpose of this trial?

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.

Research Team

Lauren Nye

Principal Investigator

University of Kansas

Eligibility Criteria

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

Obese (BMI >= 30 kg/m^2) OR overweight (BMI 25 to < 30 kg/m^2) with specific elements of metabolic syndrome

Willing to undergo specific medical tests and procedures

Certain laboratory values within defined ranges

Exclusion Criteria

Breastfeeding or nursing within past 12 months

I have not had cancer or specific medical conditions recently.

I am currently taking prescription drugs that suppress my immune system.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive tamoxifen with or without omega-3 fatty acids for 180 days

26 weeks

Regular visits for monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-5 weeks

1 visit (in-person)

Treatment Details

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.

Participant Groups

Group I: Group 2 (tamoxifen, omega-3 fatty acids) Experimental Treatment 6 Interventions

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.

Group II: Group 1 (tamoxifen) Experimental Treatment 5 Interventions

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:

Approved in European Union as Nolvadex for:

• Breast cancer
• Infertility
• Gynecomastia

Approved in United States as Tamoxifen citrate for:

• Breast cancer
• Reduction in breast cancer incidence in high-risk women
• McCune-Albright Syndrome

Approved in Canada as Tamoxifen for:

• Breast cancer
• Reduction in breast cancer incidence in high-risk women

Approved in Japan as Tamoxifen for:

• Breast cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Combination of Antiestrogens and Omega-3 Fatty Acids for Breast Cancer Prevention. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

In vitro effects on MCF-7 breast cancer cells of signal transduction inhibitor/tamoxifen/eicosapentaenoic acid combinations and their simultaneous delivery across skin. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The impact of fish oil on the chemopreventive efficacy of tamoxifen against development of N-methyl-N-nitrosourea-induced rat mammary carcinogenesis. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Influence of omega-3 fatty acids on Tamoxifen-induced suppression of rat mammary carcinogenesis. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Omega-3 free fatty acids inhibit tamoxifen-induced cell apoptosis. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Influence of Obesity on Breast Density Reduction by Omega-3 Fatty Acids: Evidence from a Randomized Clinical Trial. [2018]