AS130 - Randomized controlled trial of fat reduction, calcium/Vitamin D supplementation, hormone replacement therapy, and risk of proliferative forms of benign breast disease

[This page is intended to provide a study summary, the sections of which are below. Please complete these sections, as applicable. The headings below are suggested headings. You can remove inapplicable sections, or add new ones relevant to your study]

Investigator Names and Contact Information

Dr. Thomas Rohan

Objectives

(1) To test the hypothesis that:

(a) adoption of a low-fat dietary pattern is associated with reduced risk of proliferative forms of benign breast disease.

(2) To explore the hypotheses that:

(a) use of hormone replacement therapy is associated with increased risk of proliferative forms of benign breast disease.

(b) supplementation with calcium/vitamin D is associated with reduced risk of proliferative forms of benign breast disease.

Overview

Our focus will be on women participating in the Women's Health Initiative (WHI) clinical trial (all components). Women in the trial are contacted 6-monthly to determine whether they have had any surgical procedures, including breast biopsies (this information is reported on the Medical History Update Form- i.e., Form 33 (Appendix 1)). We propose to use this information to obtain histological sections for those subjects who have had biopsies, and to subject the slides to a standardized histological review. Event rates (occurrence of proliferative forms of benign breast disease) will then be compared in the respective intervention and control arms using standard statistical methods.