• Postmenopausal Evaluation and Risk Reduction with Lasofoxifene (PEARL)
• A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of HRT
  on Mammography Assessments and Breast Density

Susan D Reed, MD, MPH

PEARL is a multicenter international randomize controlled phase III trial investigating the effect of lasofoxifene on new (radiographic) vertebral fractures in 7,500 women with osteoporosis. Lasofoxifene is a selective estrogen receptor modulator (SERM). We will compare two doses of lasofoxifene (0.25 mg/d and 0.5 mg/d) combined wit calcium and Vitamin D to the control group receiving calcium and Vitamin D and evaluate any differences of new radiographic vertebral fractures between the three groups at yearly intervals up to three years.

The main secondary outcome to be evaluated is the incidence of ER+ breast cancers over a 5-year period. Other secondary outcomes to be evaluated include: all clinical fractures, hip fractures, clinical vertebral fractures, all non-vertebral fractures, height, bone mineral density, coronary events, all causes of mortality, health care resource utilization, quality of life, pain and limited activity days, lipid changes, biochemical markers of bone turnover, selected markers of inflammation and coagulation, breast density, and endometrial safety.

Pre-clinical and clinical Phase I and II studies have already demonstrated safety and efficacy of lasofoxifene. The study will be run under the auspices of the USA Food and Drug Administration requirements for Investigational New Drugs (IND).

Funding Source: Group Health Center for Health Studies (flow through from Pfizer, Inc)
Contact: Susan D Reed, MD, MPH, (206) 744-4292
Ends 3/31/09

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A Population-Based Randomized Trial to Assess the Effects of Short-Term Cessation of HRT on Mammography Assessments and Breast Density

Susan D Reed, MD, MPH

Screening mammography is an essential tool for early detection of breast cancer. Early detection increases women's options, including the opportunity for breast conserving therapy, and reduces breast cancer death. Mammography is not a perfect tool, and there is an ongoing need to improve its performance. Some breast cancers are missed or discovered in advance stages. There is a lot of scientific evidence that using hormone replacement therapy increases the density of women's breasts in 17% to 73% of women who use it.

The randomized trial proposed in this application is designed to test whether stopping hormones for 1-2 months before a mammogram can significantly improve the performance of the mammogram. We will enroll 1,500 women who are due for their screening mammogram. We will randomly assign 500 women to each of three groups In one group, women will stop taking their hormones one month before their screening mammogram, the second group women will stop two months before their mammogram, and in the third group women will continue using their hormones.

We will test how their breast density changes and will measure the number of women who receive an uncertain mammographic interpretation. We will also monitor the number of adverse events to see if stopping and starting hormones is associated with untoward events.

Funding Source: Group Health Center for Health Studies
(flow through from Department of Defense)
Contact: Susan D Reed, MD, MPH, (206) 744-4292
Ends 12/31/08

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