Prevention Clinical Trials

Studies for Postmenopausal Women

Letrozole Phase II Trial: For Postmenopausal Women on Hormone Replacement Therapy (HRT)
Women at increased risk for breast cancer who need hormone replacement therapy to control menopause symptoms currently have no standard therapy options to reduce their risk. This trial addresses this need by using letrozole (a type of drug used successfully in breast cancer treatment) to reduce breast tissue hormone levels and rate of cell growth without significantly lowering blood estrogen levels. This approach was successful in a six-month pilot trial in which women who took letrozole for six months experienced a reduction in atypical cells and overall cell growth without an increase in hot flashes. In this follow-up study, supported by the National Cancer Institute, women continue on hormone replacement and are randomized to letrozole or placebo the first six months. Then all women receive letrozole the second six months of the study. If you wish to participate, you first need to have a fine-needle aspiration and a DEXA scan, which are both paid for by the study. If atypical or borderline atypical cells are found, you will be eligible to start the study. You would have two more aspirations at six and 12 months. In our hands, the average discomfort level from the fine-needle aspiration is 1 on a 0 to 10 scale.

Eligibility Criteria

• Participants must be postmenopausal between the ages of 30 and 69.
• Participants must be on a stable dose of hormone replacement therapy for at least six months.
• Participants must not have a diagnosis of osteoporosis.
• Participants must be willing to have breast tissue sampled by fine-needle aspiration (RPFNA) to determine if pre-cancerous cells are present and to measure the rate of cell growth.

Exclusion Criteria

• Women who have had prior invasive breast cancer
• Women who are currently taking anti-coagulants (blood thinners)
• Women who have breast implants

Trial Involvement

• Six-month commitment on double-blind placebo-controlled trial where participants will be randomized to take placebo or letrozole
• Have a follow-up fine-needle aspiration (RPFNA) six months after on-study appointment
• Participants will have the option of taking letrozole for an additional six months with another follow-up RPFNA

If you are interested in this trial, please call Jennifer Nydegger, at 913.588.3963, or email her at jnydegger@kumc.edu.

High Dose Omega-3 Fatty Acids Trial: For Postmenopausal Women On or Off HRT
Epicosapentaenoic acid (EPA) and docosahexaenoic acid( DHA) are anti-inflammatory omega 3 fatty acids that can substitute for inflammatory omega 6 fatty acids in cell membranes and profoundly influence cell signaling and behavior. Animal models and epidemiologic studies suggest that ingestion of higher amounts of EPA and DHA relative to omega 6 fatty acids may reduce the risk of breast cancer. The most efficient source of EPA and DHA are marine fish, which in turn get it from micro-algae. American women typically have little EPA and DHA in their diets.

We are conducting a six-month trial of high-dose EPA (1,800 mg) and DHA (1,500mg) per day in the form of four Lovaza capsules to determine the effect on blood and breast tissue markers of risk. This dose is known to be safe, with minimal side effects. To be eligible for trial, women must have evidence of increased risk, such as a family history of breast cancer, prior breast biopsies showing pre-cancerous changes or high mammographic breast density. They must also have evidence of pre-cancerous changes on baseline fine-needle aspiration (RPFNA). Funding for these studies comes from the Breast Cancer Research Foundation and the Kansas Bio-Science Authority.

Eligibility Criteria

• Participants must be postmenopausal between the ages of 25 and 69 with risk factors for breast cancer .
• Participants must be willing to continue the same hormonal milieu present at baseline throughout trial (cannot start or stop any type of hormone replacement therapy with the exception of vaginal estrogens).
• Participants must be willing to have breast tissue sampled by fine-needle aspiration (RPFNA) to determine if pre-cancerous cells are present and rate of cell growth at baseline and at the conclusion of the study. They may not have ingested any fish oil supplements or flaxseed supplements for three weeks prior to the fine needle aspiration.
• Participants must have had a screening mammogram within six months of entering the interventional portion of the study and at the study conclusion.

Exclusion Criteria

• Women who have had prior invasive breast cancer
• Women who are currently taking anticoagulants (blood thinners)
• Women who have breast implants
• Women who regularly take non-steroidal anti-inflammatory drugs (NSAIDS such as ibuprofen)
• Women who have a history of an allergy, including hives, to fish products

Trial Involvement

• Six-month commitment taking four capsules of prescription strength omega-3 fatty acids (1,800 mg EPA and 1,500 mg DHA per day). This is not a randomized, placebo-controlled trial.
• Agree to monthly phone calls from study coordinator and follow-up blood draw, mammogram and fine-needle aspiration.

If you are interested in this trial, please call Jennifer Nydegger, at 913.588.3963, or email her at jnydegger@kumc.edu.

Studies for Premenopausal Women

Flaxseed Lignan: For Premenopausal Women Not on Oral Contraceptives
Lignans are weak estrogens found in nature in edible plants, particularly in oily seeds such as flaxseed. One of the most common plant lignans, secoisolariciresinol diglycoside or SDG for short, is converted by bacteria in our gastrointestinal tract to enterodiol and enterolactone, which in premenopausal women may act as a buffer to the estrogen produced by the body. Animal studies and human epidemiologic studies suggest that higher levels of enterodiol and enterolactone reduce the risk for breast cancer. Most Americans, however, have very low levels of enterodiol and enterolactone in their blood. We are testing whether a single capsule containing 50 mg of the flaxseed extract SDG (amount contained in 25 grams of flaxseed) taken once a day for one year vs. a placebo reduces the rate of breast cell growth and the proportion of premenopausal women who have breast cells that appear atypical. A prior pilot study by our group (published in Cancer Prevention Research 2010) suggests that this amount of SDG caused little in the way of side effects but favorably affected these risk biomarkers for breast cancer. However, until we perform this larger, placebo-controlled trial, we will not be confident that this is true. Funding for this trial comes from the Komen for the Cure Foundation.

Eligibility Criteria

• Participants must be premenopausal between the ages of 21 and 49.
• Participants must have had at least four menstrual cycles in the past year.
• Participants must not be obese.
• Participants must be willing to have an RPFNA at baseline and six months later.
• Participants must have atypia or borderline atypia in their RPFNA and some evidence of cell growth.

Exclusion Criteria

• Consumption of antibiotics, anticoagulants, fish oil or other or supplements containing SDG (flaxseed or sesame seed) during the three weeks prior to baseline RPFNA
• Currently enrolled on an interventional investigational study
• Bilateral breast implants
• Invasive breast cancer or other invasive cancer diagnosis within five years
• Current anticoagulant use

Trial Involvement

• 12-month commitment on double-blind placebo-controlled trial where participants will be randomized to take placebo or prescription strength flaxseed
• Agree to phone calls from study coordinator every three months and follow-up blood draw, mammogram and fine-needle aspiration
• Have a follow-up fine-needle aspiration (RPFNA) six months after on-study appointment

If you are interested in this trial, please call Jessica Box, at 913.588.3622, or email her at jbox@kumc.edu.

High Dose Omega-3 Fatty Acids Trial: For Premenopausal Women On or Off Oral Contraceptives
Epicosapentaenoic acid (EPA) and docosahexaenoic acid( DHA) are anti-inflammatory omega 3 fatty acids that can substitute for inflammatory omega 6 fatty acids in cell membranes and profoundly influence cell signaling and behavior. Animal models and epidemiologic studies suggest that ingestion of higher amounts of EPA and DHA relative to omega 6 fatty acids may reduce the risk of breast cancer. The most efficient source of EPA and DHA are marine fish,which in turn get it from micro-algae. American women typically have little EPA and DHA in their diets. We are conducting a six-month trial of high dose EPA (1,800 mg) and DHA (1,500mg) per day in the form of four Lovaza capsules to determine the effect on blood and breast tissue markers of risk in pre and postmenopausal women. This dose is known to be safe, with minimal side effects. Funding for these studies comes from the Breast Cancer Research Foundation and the Kansas Bio-Science Authority.

Trial Eligibility

• Participants must be premenopausal and between the ages of 25 and 54 and must have had a menstrual period within the past 12 months. Women who are not menstruating regularly due to use of certain types of contraceptives may be entered with restrictions.
• Participants must be willing to continue the same hormonal milieu present at baseline throughout trial. If not using an oral, vaginal or topical contraceptive, participants must be willing to actively use barrier methods of contraception to prevent pregnancy.
• Six months or more must have elapsed from completion of a prevention intervention trial (with exception of a weight reduction trial).
• Participants over 40 must have had a screening mammogram within six months of entering the interventional portion of the study.
• Participants must be willing to have breast tissue sampled by fine-needle aspiration (RPFNA) to determine if pre-cancerous cells are present and the rate of cell growth at baseline and at the conclusion of the study.

Exclusion Criteria

• Women who have had prior invasive breast cancer diagnosed or treated within the past five years
• Women who are currently taking anticoagulants
• Women who have breast implants
• Women who have taken omega 3 fatty acid supplements within three weeks prior to their baseline RPFNA
• Women who regularly take NSAIDS (i.e Advil or Aleve)
• Women who have a history of an allergy, including hives, to fish products
• Women who are obese

Trial Involvement

• Six-month commitment to taking four capsules of prescription strength omega-3 fatty acids (1,800 mg EPA and 1,500 mg DHA per day). This is not a randomized, placebo-controlled trial.
• Agree to monthly phone calls from study coordinator and follow-up blood draw, mammogram and fine-needle aspiration.

If you are interested in this trial, please call Jessica Box, at 913.588.3622, or email her at jbox@kumc.edu.