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Selective Estrogen Receptor Modulator

Tamoxifen + Omega-3 for Breast Cancer Risk Reduction

Phase 2

Waitlist Available

Led By Lauren Nye

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Postmenopausal female as defined by specific criteria

Age 45 - 65

Must not have

Type I or type II diabetes mellitus requiring current pharmacologic treatment

Planned initiation of a structured weight loss intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether taking tamoxifen, a drug that blocks the effects of estrogen, can reduce the risk of breast cancer in postmenopausal women who are overweight or obese and at higher

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Tamoxifen may cause hot flashes, vaginal symptoms, leg cramps, blood clots and cataracts. Omega-3s are generally well-tolerated but can lead to fishy aftertaste, upset stomach or bleeding risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a postmenopausal woman.

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I am between 45 and 65 years old.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am planning to start a structured weight loss program.

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I am currently using hormone therapy.

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

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

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I am currently taking prescribed medications.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in serum adiponectin

Secondary study objectives

Change in insulin resistance

Change in insulin secretory function

Change in insulin sensitivity

+1 more

Other study objectives

Adiponectin:leptin ratio

Anterior gradient protein 2 homolog messenger ribonucleic acid

Anterior gradient protein 2 homolog protein

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mammography

2015

N/A

~1450

Biospecimen Collection

2004

Completed Phase 3

~2030