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Selective Estrogen Receptor Modulator

Group 2 (tamoxifen, omega-3 fatty acids) for Breast Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in serum adiponectin

Secondary outcome measures

Change in insulin resistance

Change in insulin secretory function

Change in insulin sensitivity

+1 more

Other outcome measures

Adiponectin:leptin ratio

Anterior gradient protein 2 homolog messenger ribonucleic acid

Anterior gradient protein 2 homolog protein

+9 more

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 2

~1730

Tamoxifen

2005

Completed Phase 4

~29860

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,657 Previous Clinical Trials

40,933,601 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Lauren NyePrincipal InvestigatorUniversity of Kansas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research study?

"To be eligible for enrollment in this clinical trial, potential participants must have a diagnosis of breast cancer and fall within the age range of 45 to 65. A total of 66 candidates will be accepted into the study."

Answered by AI

Has the Food and Drug Administration officially authorized Group 1 (tamoxifen) for medical usage?

"Given that this trial is in Phase 2, our team at Power rates the safety of Group 1 (tamoxifen) as a 2. Although there is some existing data supporting its safety, no efficacy data has been obtained yet."

Answered by AI

Are there any ongoing efforts to enroll participants in this current medical study?

"Based on the information available on clinicaltrials.gov, it appears that this particular trial is not currently seeking participants. The initial posting of the study was recorded on June 16th, 2024, and the most recent update occurred on January 4th, 2024. However, there are a substantial number of other studies (specifically 4715) actively enrolling patients at this time."

Answered by AI

Does the inclusion criteria of this medical study allow for participation by individuals aged 75 and above?

"Only individuals between the ages of 45 and 65 are eligible to participate in this clinical trial. It is worth noting that there are a total of 157 trials available for patients under the age of 18, while there are 4574 trials specifically targeting patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06195306.

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