Tamoxifen + Omega-3 for Breast Cancer Risk Reduction

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Anticoagulants, Aspirin, Hormone therapy, others

Disqualifiers: Diabetes, Breastfeeding, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 26 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether tamoxifen, with or without omega-3 fatty acids, can lower the risk of breast cancer in postmenopausal women who are overweight or obese. Tamoxifen blocks estrogen in the breast, while omega-3s may help prevent cancer in those carrying extra weight. Participants will be divided into two groups: one will receive tamoxifen alone, and the other will receive tamoxifen combined with omega-3s. The trial seeks postmenopausal women who are overweight or obese and have a higher risk of developing breast cancer, such as those with a family history of the disease or specific genetic markers. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to important findings in breast cancer prevention.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking certain medications, such as prescription anticoagulants, daily aspirin (81mg or higher), hormone therapy (except vaginal estrogen), and certain other drugs. If you are on these medications, you may need to discontinue them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study showed that tamoxifen significantly lowered the risk of invasive breast cancer in women at high risk. Most participants believed the benefits outweighed the risks, though a few disagreed. While tamoxifen is generally safe, it can cause side effects and may not suit everyone.

Research suggests that combining tamoxifen with omega-3 fatty acids is well tolerated. Studies have shown no evidence of harmful effects, making this combination a promising option for reducing breast cancer risk. Omega-3 fatty acids, often found in fish oil, may enhance tamoxifen’s effects by reducing liver-produced fats and possibly blocking cancer growth.

Overall, both treatments appear safe. However, discussing any treatment choice with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining tamoxifen with omega-3 fatty acids for reducing breast cancer risk because it introduces a novel approach to treatment. Typically, tamoxifen is used alone to block estrogen receptors in breast tissue, but adding omega-3s may enhance this effect by reducing inflammation and potentially interfering with cancer cell growth. This combination could offer a dual-action strategy that not only targets estrogen receptors but also leverages the anti-inflammatory and health-boosting properties of omega-3s, making it a promising option for boosting tamoxifen’s effectiveness.

What evidence suggests that this trial's treatments could be effective for reducing breast cancer risk?

Research has shown that tamoxifen, which participants in this trial may receive, can lower the risk of breast cancer, particularly in women with tumors that respond to estrogen. One study found that tamoxifen reduced the risk of invasive breast cancer by 49%. The FDA has approved tamoxifen for preventing breast cancer in women at higher risk. In this trial, one group will receive tamoxifen alone, while another group will receive a combination of tamoxifen and omega-3 fatty acids. Adding omega-3 fatty acids to tamoxifen might enhance its effectiveness in preventing cancer. Some studies suggest that omega-3s could help stop cancer growth, potentially making this combination more effective. Early results indicate that this combination might work well for postmenopausal women who are overweight or obese. ^{4 5 6 7 8}

Who Is on the Research Team?

Lauren Nye

Principal Investigator

University of Kansas

Are You a Good Fit for This Trial?

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

Obese (BMI >= 30 kg/m^2) OR overweight (BMI 25 to < 30 kg/m^2) with specific elements of metabolic syndrome

Willing to undergo specific medical tests and procedures

Certain laboratory values within defined ranges

Exclusion Criteria

Breastfeeding or nursing within past 12 months

I have not had cancer or specific medical conditions recently.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive tamoxifen with or without omega-3 fatty acids for 180 days

26 weeks

Regular visits for monitoring and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

3-5 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Omega-3 Fatty Acids
• Tamoxifen

Trial Overview 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.

How Is the Trial Designed?

Group I: Group 2 (tamoxifen, omega-3 fatty acids) Experimental Treatment 6 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 Treatment 5 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 for the following indications:

Approved in European Union as Nolvadex for:

• Breast cancer
• Infertility
• Gynecomastia

Approved in United States as Tamoxifen citrate for:

• Breast cancer
• Reduction in breast cancer incidence in high-risk women
• McCune-Albright Syndrome

Approved in Canada as Tamoxifen for:

• Breast cancer
• Reduction in breast cancer incidence in high-risk women

Approved in Japan as Tamoxifen for:

• Breast cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK532905/

Tamoxifen - StatPearls - NCBI Bookshelf - NIH This drug is particularly effective for patients with estrogen receptor–positive tumors and is approved by the US Food and Drug Administration ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01196936

Low-Dose Tamoxifen Citrate in Reducing Breast Cancer ... Study Overview. This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors. ...

3. academic.oup.com academic.oup.com/jnci/article/90/18/1371/897928

Tamoxifen for Prevention of Breast Cancer: Report of the ... Results: Tamoxifen reduced the risk of invasive breast cancer by 49 ... Also self-reported at each visit were data from the Medical Outcomes Study ...

4. thelancet.com thelancet.com/journals/lanonc/article/PIIS0140-6736(12)61963-1/fulltext

Long-term effects of continuing adjuvant tamoxifen to 10 ... The risk of recurrence during years 5–14 was 21·4% for women allocated to continue versus 25·1% for controls (absolute recurrence reduction 3·7%); figure 3.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4053098/

Oral low dose and topical tamoxifen for breast cancer prevention A trend toward a beneficial effect from low dose tamoxifen in reducing breast cancer events was observed, with greater efficacy being seen in the ER+, PgR+, Ki- ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2005/17970s053lbl.pdf

NOLVADEX - (Tamoxifen Citrate) - accessdata.fda.gov For the primary endpoint, the incidence of invasive breast cancer was reduced by 43% among women assigned to NOLVADEX (44 cases - NOLVADEX, 74 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC117858/

Tamoxifen for breast cancer prevention: safety warning Tamoxifen is not appropriate for breast cancer prevention in women at low risk of the disease (5-year risk less than 1.66%), and discussions about modifiable ...

8. my.clevelandclinic.org my.clevelandclinic.org/health/treatments/9785-tamoxifen

Tamoxifen: Uses, Side Effects & Risks The study found that the benefits of tamoxifen outweighed the risks for 74% of their participants, but not for 20% of their participants.