The purpose of this trial is to evaluate the effect of vitamin D on mammographic density (MD) in premenopausal women at high risk of breast cancer, and secondarily to gain information concerning the ability of vitamin D to modulate the expression of breast tissue markers and serum markers. The study has an optional breast biopsy component built in to obtain healthy breast tissue from study participants to investigate the impact vitamin D may have on breast tissue biomarkers. The study uses a double-blind randomization to compare high-dose cholecalciferol of 20,000 IU weekly for one year versus placebo weekly for one year. The main outcome measure of this trial is change in mammographic breast density between mammograms pre-intervention and one-year post intervention.
Southwest Oncology Group (SWOG) is sponsoring the study. The investigators include: Katherine Crew, MD, MS, and Dawn Hershman, MD, MS, Columbia University, New York, NY; Powel Brown, MD, PhD, MD Anderson Cancer Center, Houston, TX; Gary Goodman, MD, SWOG Chemoprevention Subcommittee and Fred Hutchinson Cancer Research Center, Seattle, WA; Garnet Anderson, PhD, and Danika Lew, MS, SWOG Data Operations and Statistical Center, Seattle, WA; and all participating SWOG members, the Community Clinical Oncology Program (CCOP), and Affiliate Medical Oncologists and Surgeons.
SWOG is one of the five cooperative groups that together comprise the National Cancer Institute’s National Clinical Trials Network. SWOG designs and conducts multidisciplinary clinical trials to improve the practice of medicine in preventing, detecting, and treating cancer, and to enhance the quality of life for cancer survivors. Learn more about SWOG here: http://www.swog.org/Visitors/AboutUs.asp
This study is investigating whether high-dose vitamin D supplements reduce breast density, as seen on mammography. Breast density is associated with breast cancer risk. The researchers wanted to enroll up to 300 volunteers and contacted the Army of Women (AOW) to help with their recruitment efforts. The Call to Action for this study was sent to AOW members on May 15, 2013, and the researchers closed enrollment on Sept. 16, 2014. The AOW provided them with 172 women who were interested in enrolling in the study.