July 1, 2002
Dana-Farber/Harvard Cancer Center Seeks Candidates for Three Breast
Cancer Prevention Clinical Trials
Women with Increased Serum Estradiol (WISE)
Questions and Answers
What is the study of Women with Increased Serum Estradiol (WISE)?
The WISE Trial is a clinical trial (research study conducted with volunteers) designed to evaluate the effects of a medication named letrozole (Femara®) in post-menopausal women at increased risk for breast cancer. Just as elevated cholesterol levels identify individuals at risk for heart disease, elevated estrogen levels identify women at risk for breast cancer. In the WISE Trial, levels of naturally occurring estrogen in the body will determine breast cancer risk.
What is letrozole?
Letrozole is a medication taken orally as a pill. It has been FDA approved and is currently used in the treatment of breast cancer. Letrozole decreases the level of circulating estrogen in the blood. In previous studies, letrozole has been well tolerated in both healthy volunteers and breast cancer patients, and no life-threatening side effects have been reported. It is hoped that in the future, women with elevated estrogen levels will be able to take a medication like letrozole to decrease these estrogen levels, and therefore decrease their risk for developing breast cancer.
How do I know if my estrogen levels are elevated?
A blood test is the only way to determine if your estrogen levels are elevated. If you are interested in possible participation in the WISE Trial, we will collect a blood sample to determine your estrogen level and your eligibility status for the trial.
Who is eligible to participate in the WISE Trial?
Women at increased risk for developing breast cancer, as defined by their levels of estrogen, who have gone through menopause and are at least 35 years old, can participate in the WISE Trial.
Why can't premenopausal women participate in the WISE Trial?
Letrozole is not effective in premenopausal women because this medication does not block estrogen formation in the ovary, where most estrogen is made before menopause.
How does letrozole work?
Letrozole suppresses the production of estrogen in all peripheral (fat) tissues throughout the body.
What effects will be monitored in the WISE Trial?
This trial is a first step in a new approach to breast cancer prevention. It will assess the feasibility of giving letrozole to high-risk, post-menopausal women and monitor the medication's effect. The effects that will be monitored throughout the trial include breast health, bone density changes, lipid levels and breast density on mammograms. The WISE Trial, however, is too small and too brief to evaluate breast cancer prevention. If the trial results are significant, we would hope to develop a larger trial that could address breast cancer prevention. During the one-year trial, you will be carefully monitored by physicians and medical professionals.
What other factors effect eligibility for the study?
Some exclusions from study participation include a history of prior breast cancer, severe osteoporosis, and the use of hormone replacement therapy (estrogen or an estrogen/progesterone combination). Women who have been or are currently using hormone replacement therapy (HRT) may participate in the trial if they discontinue HRT at least three months prior to participation. Each participant and her health condition will be evaluated on an individual basis to ensure that participation in the study is appropriate for her.
What are the common side effects of letrozole?
Some side effects (reported in up to 21 percent of women with breast cancer taking letrozole) include musculoskeletal pain, hot flashes, nausea, vomiting, headache and fatigue. Other side effects (reported in less that 9 percent of women) are chest pain, constipation, diarrhea, abdominal pain, and coughing.
Does letrozole have any serious side effects?
Rare but serious side effects (reported in less than 5 percent of women) that may occur as a result of taking letrozole include (1) weakening of bones resulting in fractures and (2) high cholesterol.
Will everyone receive letrozole?
No. Participants in the WISE Trial will be assigned randomly to receive letrozole or placebo (2:1 ratio). Neither the physician nor the participant will know which she is receiving. All of the women in the study will take one pill every day for one year: 2/3 will take letrozole and 1/3 will take placebo. The dose of letrozole will be the current standard of 2.5 mg/day.
How will participants' safety be monitored?
Participants will be seen by a WISE Trial physician and/or project manager every three months. Medical exams, mammograms, bone densitometry, blood tests and other measures will be administered to ensure each participant's health and safety.
What will I need to do while I am in the study?
Participants are required to have breast exams, mammograms, bone density scans, urine tests, and blood tests. These exams are necessary in order to be enrolled in the trial and to continue participation throughout the trial. The medical exams are at no cost to you; all study-related medical tests and procedures will be paid by the WISE Trial.
What is a bone density scan?
The dual-energy X-ray absorptiometry scan is a non-invasive, low dose X-ray bone density test that will be done at baseline (within 30 days of enrollment) and at 12 months. Bone density of the spine, total body bone density and body composition of fat and lean tissue will be measured. Scanning will take approximately one minute, and the whole procedure takes 5-10 minutes.
How can I find out more about the WISE Trial?
You can receive more information on the WISE Trial by calling Patricia Peters, project manager for WISE, at the Dana Farber Cancer Institute at (617) 632-5399 or (800) 828-6622 ext. 2.
