Breast and Ovarian Cancer Risk and Prevention
Research Studies
WISE: Women with Increased Serum Estradiol
Why is this study being done?
The WISE trial asks whether letrozole, a medication that lowers estrogen levels, can help reduce the chance of developing breast cancer in women at increased breast cancer risk. Women who have higher levels of the female hormone estrogen after menopause are at increased risk of developing breast cancer. Letrozole is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of women with breast cancer. Letrozole works by lowering estrogen levels and has been shown to be better than tamoxifen at preventing a second breast cancer in the opposite breast. The study also asks if estrogen levels can be used like cholesterol levels, to identify women at higher risk, and as a treatment target.
Who is eligible?
Women who:
- are postmenopausal and 35 years of age or over who are generally healthy and have at least one breast that has not been treated for breast cancer or DCIS;
- are not taking an aromatase inhibitor (i.e. Armidex, Exemestane, etc.);
- if applicable, have finished all adjuvant therapy (treatment starting after diagnosis), AND have been off tamoxifen for at least 60 days;
- have not had other cancer except skin cancer or superficial cervical cancer within the past five years;
- have an elevated level of the female hormone estradiol (a form of estrogen). This will be measured in a free screening blood test.
Who is not eligible?
Women who:
- are participating in any other cancer prevention study or osteoporosis prevention study involving medication;
- have a history of osteoporosis or bone loss;
- have known lipid problems or heart disease that is uncontrolled;
- cannot take letrozole for any reason.
How long is the study?
One year.
What is involved?
- If you are eligible and choose to participate, first you will need to sign an informed consent, fill out a brief questionnaire and have blood drawn to see if your estrogen level is high enough to make you eligible for the study. This can be done through your local doctor or at Dana-Farber.
- If you are eligible, you will need to come to Dana-Farber for enrollment in the study and three follow-up visits over the course of one year.
At each visit you will have:
- Physical exam and breast exam;
- Blood drawn;
- Urine collection;
- A questionnaire to complete;
- At three and nine months after enrollment, we will call you to check-in.
At the beginning and end of the study you will have a:
- Mammogram
- Bone mineral density scan
Women will also take one pill per day during the year on the study. Participants will take either Letrozole or a placebo (inactive) pill that looks exactly like Letrozole. The chance a woman will get Letrozole is two out of three; two-thirds of women on the study will take Letrozole, and one-third will take a placebo. Neither participants nor the study doctors will know which medication they are taking during the study. The treatment will be randomly assigned by the pharmacist at Dana-Farber and will be revealed at the end of the study. If for medical reasons during the study it becomes important that a woman and her doctor know what she is taking, this information will be made known to the study team and participant. Women who wish to continue taking Letrozole for a total of five years (the amount of time it is being given on other prevention studies) will be given Letrozole for free at the end of the study.
How can I get more information about the WISE trial?
Hannah Green, MPH
hannah_green@dfci.harvard.edu
