Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

Conditions

• Breast Atypical Hyperplasia
• Breast Carcinoma
• Breast Ductal Carcinoma In Situ
• Breast Lobular Carcinoma In Situ

Eligibility Criteria

Sex

FEMALE

Age

45 Years - 74 Years

Healthy Volunteers

Accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of blood samples
• Mammography — PROCEDURE
  Undergo mammography
• Omega-3-Acid Ethyl Esters — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies
• Random Periareolar Fine-Needle Aspiration — PROCEDURE
  Undergo RPFNA
• Tamoxifen — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Jul 28, 2025

Status verified

May 2026

Primary completion

Jan 1, 2027

Completion

Jan 1, 2028

Study Design

Enrollment

66 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1 (tamoxifen)
  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.
• Experimental: Group 2 (tamoxifen, omega-3 fatty acids)
  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.

Primary Outcome Measure

Change in serum adiponectin [ Time Frame: From baseline up to end of treatment (6 months) ]

Locations (3)

Find similar trials in Kansas City, KS

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