KEEPS Mammographic Density And Breast Health Ancillary Study
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Combined estrogen and progestin therapy has been shown to increase mammographic density and
incidence of breast cancer in randomized trials. The investigators propose to examine the
effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast
density, rates of abnormal mammogram, and circulating estrogens in the ongoing,
already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical
trial with a primary goal of examining the effects of low-dose transdermal versus oral
estrogen combined with cyclic micronized progesterone on progression of subclinical
atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short
duration and small size. By determining the effects of low-dose hormone therapy on the
breast, the proposed ancillary study will add important information about the estimated
balance of risks and benefits associated with low-dose HT and will help guide future research
trials.
Phase:
N/A
Details
Lead Sponsor:
Brigham and Women's Hospital
Collaborators:
Albert Einstein College of Medicine Albert Einstein College of Medicine of Yeshiva University Columbia University Kronos Longevity Research Institute Mayo Clinic National Cancer Institute (NCI) University of California, San Francisco University of Utah University of Washington Yale University