Letrozole (also known as Femara) is an FDA-approved drug for breast cancer treatment. It belongs to a class of drugs called aromatase inhibitors which reduce the estrogen levels in the entire body including the breast tissue where high levels of estrogen are associated with high risk of breast cancer. The low estrogen in the body can cause menopausal symptoms which is a well known side-effect of these drugs. In this study, participants already on hormone replacement therapy are given letrozole to reduce breast estrogen without exacerbate their menopausal symptoms.

We have performed a pilot study in which letrozole was administered to 42 high risk postmenopausal women who had been on a stable dose of estrogen or estrogen plus progestin for at least six months. Excess cell growth in the breast ducts was reduced by 2/3 without increasing menopausal symptoms.

Eligibility Criteria

Participants must be postmenopausal between the ages of 30-69
Participants must be on a stable dose of HRT for at least 6 months
Participants must have adequate bone health with a DEXA scan T-score greater than -1.0; or -1.5 to -1.0 if on active osteoporosis treatment
Must have random pariareolar fine needle aspiration (RPFNA) with evidence score of hyperplasia with proliferation rate of 1.5% or higher

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 random pariareolar fine needle aspiration (RPFNA) six months after on-study appointment
Participants will have the option of taking letrozole for an additional six months after follow-up RPFNA

Any participant who chooses this option will have a third RPFNA at the conclusion of their medication 12 months after their on-study visit

Diet & Exercise Trial: For overweight postmenopausal women not on HRT

The Diet & Exercise program is a six month study examining the changes in breast tissue by reducing body weight by ten percent. Eligible participants partake in a calorie and portion control diet consisting of pre-packaged meals, shakes and five servings of fruits and vegetables per day. Participants are also required to log 300 minutes of physical exercise per week as well as attend a behavior counseling session one evening per week.

The cost is approximately $42 per week for the pre-packaged meals and shakes.

We are very pleased to report that after completion of the six-month study the first group lost an average of 24 pounds per person!

Eligibility criteria

Participants must be postmenopausal
Participants must not take any hormone replacement therapy for 12 months prior to on-study visit
Participants must not take any chemopreventatives (i.e. Tamoxifen or Evista) for 12 months prior to on-study visit
Body Mass Index (BMI) has to be greater than 25

Exemestane vs. Placebo (EXCEL Trial): For postmenopausal women not on HRT

Exemestane (also known as Aromasin) is an FDA approved drug for breast cancer treatment which belongs to the class of drugs called aromatase inhibitors. Women in this trial are randomized to five years of Exemestane vs. Placebo.

Eligibility criteria

Participants must be postmenopausal and must not have had prior ductal carcinoma in situ or invasive cancer
Participants must be in general good health without osteoporosis or prior bone fracture
Participants must not be taking hormone replacement therapy

Premenopausal Women:

Acolbefene Trial

The Acolbefene study is a six-month program for premenopausal women utilizing an anti-estrogen similar to tamoxifen, but with fewer side-effects. It can cause hot flashes similar to tamoxifen, but it has fewer uterine side effects and is not known to increase the risk of cataracts or uterine cancer which can occur with tamoxifen.

Eligibility criteria

Participants must be premenopausal
Oral contraceptives as well as other types of contraceptives are allowed
Participants must have an random periareolar fine needle aspiration (RPFNA) showing hyperplasia and a proliferation rate of 2%

Osteopenia (Bone Loss) Trial

The Osteopenia study examines the prevalence of premenopausal bone loss within our clinical population. Eligible participants have the opportunity to receive a free DEXA (bone density) scan, heel ultrasound, lab draw to test hormone/Vitamin D levels and a saliva test to see if genetic variants inhibit the body’s ability to process Vitamin D. The results of the DEXA scan and heel ultrasound will be available at the study visit and participants will be provided with copies for their primary care physician. An average study visit takes 30 minutes to an hour to complete and there are no follow-up visits required.

Eligibility criteria

Participants must be pre- or peri-menopausal
Participants must have had a mammogram in the past year
Participants can not have a personal history of invasive cancer
Participants must have never been on a SERM, AI or Bisphosphonate

Tamoxifen, Reloxifene, Actonel, Boniva, Fosamax or Evista

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