Women's Health Initiative Benign Breast Disease Study

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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 University.

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.