Title: Fat Reduction, HRT USE and Benign Breast Disease Risk
Principal Investigators: Jean Wactawski-Wende, PhD, and
Maurizio Trevisan, MD, MS
Funding Agency: Albert Einstein School of Medicine
Period: 08/01/01 - 07/31/06
Abstract: The Women's Health Initiative (WHI) Fat
Reduction, HRT Use and Benign Breast Disease Risk Study (Benign
Breast Disease or BBD) is an ancillary study to the Women's Health
Initiative Clinical Trials. These trials include three separate
randomized clinical trials: Hormone Therapy vs. Placebo, Diet
Modification vs. Usual Diet and Calcium/Vitamin D supplementation
vs. Placebo). The WHI BBD study is supported by an NIH grant to Dr.
Rohan at Albert Einstein School of Medicine. The Buffalo WHI center
is participating as a subcontract with Albert Einstein
There is some evidence that diets high in fat and low in fruits, vegetables and grains, may be associated with increased risk of benign breast disease. Similarly, some, but not all studies suggest that the use of hormone replacement therapy might be associated with a small increase in risk of benign breast disease. In relation to Calcium/Vitamin D, there is reason to suspect that supplementation might be associated with a decrease in risk, although this has never been examined directly in women. This study provides the best, currently available opportunity to understand the roles of diet, Calcium/Vitamin D supplementation and hormone therapy in development of benign breast disease. Ultimately, we hope to identify factors that may be used to modify the risk of a woman developing benign breast disease.
Women who were currently participating in any of the Women's
Health Initiative Clinical Trials and reported having a breast
biopsy during the WHI study are invited to participate in the BBD
study. The study began as a pilot study in August of 1999. The
pilot concluded in June of 2000. Since August 2001, subjects who
are identified as having undergone a breast biopsy are enrolled
after providing consent.