Tamoxifen + Omega-3 for Breast Cancer Risk Reduction

Palo Alto (17 mi)

Overseen byLauren Nye

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Approved in 5 jurisdictions

Trial Summary

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.

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

I am a postmenopausal woman.

I am between 45 and 65 years old.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I am currently taking medication for type I or II diabetes.

I am planning to start a structured weight loss program.

I am currently using hormone therapy.

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

I do not have any severe illnesses or psychiatric conditions that are not under control.

I am currently taking prescribed medications.

I have been taking more than 1 gram of omega-3 supplements daily for the last 6 months.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Group I: Group 2 (tamoxifen, omega-3 fatty acids)Experimental Treatment6 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 Treatment5 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, Australia for the following indications:

🇪🇺 Approved in European Union as Nolvadex for: