Phase 2 Study of Low Dose Tamoxifen +/- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer

Summary

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.

Description

Eligibility

Age range

45–74 years

Sex

Female

Healthy volunteers

Yes

Interventions

• Procedure
  Biospecimen Collection

  Undergo collection of blood samples

• Procedure
  Mammography

  Undergo mammography

• Drug
  Omega-3-Acid Ethyl Esters

  Given PO

• Other
  Questionnaire Administration

  Ancillary studies

• Procedure
  Random Periareolar Fine-Needle Aspiration

  Undergo RPFNA

• Drug
  Tamoxifen

  Given PO

Locations (3)