The HRBP focuses research efforts on the prevention, screening and early detection of breast cancer among women with an increased risk for developing breast cancer. For more information about the HRBP’s research studies please contact Fonda Kingsley at 802-656-8502 or Fonda.Kingsley@uvm.edu
Prevention Studies
*Forthcoming* Vitamin D and Breast Cancer Biomarkers: This study is being developed by Dr. Marie Wood at UVM/FAHC as a multi-site, randomized, placebo-controlled, clinical trial investigating the role of 2,000 IU/day of vitamin D on breast cancer biomarkers such as mammographic breast density and serum markers of breast cancer risk. Several lines of evidence indicate vitamin D is associated with breast cancer risk: high levels of sunlight exposure are associated with lower rates of breast cancer; vitamin D has anti-cancer properties; and women with higher vitamin D levels appear to have lower breast cancer risk (especially among premenopausal women). This study will investigate whether vitamin D use alters mammographic breast density, an independent risk factor of breast cancer, in a group of premenopausal women. This study is projected to open to enrollment at UVM/FAHC in the Fall of 2010. Dana Farber Cancer Institute in Boston and Ohio State University in Columbus will also enroll participants in this study. Participants of this study will be randomized to take either a vitamin D tablet or a placebo tablet daily for one year. The target accrual goal for this study is 250 participants.
This study is funded by the National Cancer Institute and will be centrally coordinated by the Cancer and Leukemia Group B.
Clinical and Molecular Markers of Breast Cancer Risk: This study opened in 8/2003 as an effort to create a resource of data on women who have a moderate to increased risk for breast cancer with the purpose of better defining risk factors of breast cancer development in this specific population of women. Women who are at increased risk for breast cancer and participate in this study contribute to a clinical database and blood/serum bank and are contacted for future related studies. Clinical information regarding diet, physical activity, health behaviors, medical, social and family history, cancer specific distress and height and weight are collected. A blood sample is collected and stored for future analysis of molecular markers related to breast cancer. Currently, this study has about 475 women enrolled and is ongoing.
Serum Biomarkers Associated with Breast Density in a High Risk Population: This study is an adjunct to the HRBP’s Clinical and Molecular Markers of Breast Cancer Risk (CMM) study. This study will further investigate the association between mammographic breast density and markers of breast cancer risk, including vitamin D and components of the insulin-like growth factor axis. Research suggests vitamin D may play a role in the development of breast cancer; several studies have reported an association between high levels of sunlight exposure (solar ultraviolet B radiation converts a form of cholesterol stored in the skin into vitamin D) with low breast cancer rates. Other studies show that women with high levels of vitamin D have a reduced risk of breast cancer. Studies have also found that low vitamin D levels are associated with increased breast density, a risk factor for breast cancer.
A subset of 80-100 women who previously enrolled in the CMM study are eligible to participate in this study by completing questionnaires on diet, physical activity, health behaviors, medical, social and family history, having their height and weight measured and providing a blood sample. Currently, about 57 women have taken part in this study.
This study is funded by an award from the Vermont Cancer Center and the Lake Champlain Cancer Research Organization.
Statins and Breast Cancer Biomarkers: This is a multi-site, randomized, placebo-controlled, clinical trial investigating the role of statin (Lipitor) use on mammographic breast density and other breast cancer biomarkers. Statin use has been associated with a reduced risk of breast cancer. This study will investigate whether statin use alters mammographic breast density, an independent risk factor of breast cancer. This study opened at UVM in 1/2005 and is also enrolling participants at clinics in California, Massachusetts, Delaware, North Carolina, and Nevada. Participants of this study are randomized to take either Lipitor or a placebo daily for one year. To date, 59 participants have enrolled in this study with a target accrual goal of 100 participants.
This study is funded by the Breast Cancer Research Foundation and the Cancer and Leukemia Group B.
MAP.3- A Phase III Randomized Study of Exemestane versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer: This is multi-site study throughout Canada, the United Sates, Spain, France and Brazil conducted by the National Cancer Institute of Canada Clinical Trials Group. This study opened in 7/2004 and is a randomized, placebo-controlled clinical trial evaluating the effects of exemestane on breast cancer development in postmenopausal women. Exemestane is an aromatase inhibitor known to inhibit estrogen production and is currently approved by the FDA to treat later stage breast cancer in postmenopausal women. Women who take part in this study will be randomized to take either exemestane or a placebo for 5 years and will be followed for an additional 2 years. The rate of breast cancer occurrence will be monitored. This study has enrolled 22 women locally and over 5,000 internationally. Additional information about this study can be found on the ExCel research study website. This study closed to accrual in the Spring of 2010. Participant follow-up is ongoing.
MAP.3B- The Influence of Five Years of Exemestane on Bone Mineral Density in Postmenopausal Women at Increased Risk of Developing Breast Cancer: This study opened in the Summer of 2008 as a companion study to MAP.3. Women who consent to take part in the MAP.3 study will be eligible to enroll in this study, which will evaluate the effects of exemestane use on bone mineral density and bone biomarkers. This study will enroll 480 women throughout North America; 8 women have enrolled here at FAHC.
MAP.2- A Randomized Study of The Effect of Exemestane vs Placebo on Breast Density in Postmenopausal Women at Increased Risk for Development of Breast Cancer: This is a multi-site study throughout Canada and the United States being conducted by National Cancer Institute of Canada Clinical Trials Group. This study is a randomized, placebo-controlled clinical trial evaluating the effects of exemestane, a drug known to inhibit estrogen production, on breast density after one year of use. This study enrolled 9 patients locally and closed to accrual in 5/2004.
Screening and Detection Studies
Collection and Analysis of Breast Cells by Random Periareolar Fine Needle Aspirate (RPFNA) in Women with Breast Cancer: A Feasibility Study: This study is intended to evaluate the differences in cancerous and non-cancerous breast tissue using RPFNA. The goal is to identify markers that will aid in the evaluation of women at increased risk for breast cancer. About 42 women enrolled in this study and it is now closed to accrual. Investigators are conducting data analysis.
Evaluating the Reproducibility of Random Periareolar Fine Needle Aspiration in a Multi-Institutional Cancer and Leukemia Group B (CALGB) Cohort: This study was a multi-site study coordinated through Duke University and funded by the CALGB to investigate the methods and reproducibility of RPFNA in breast tissue retrieval. The findings from this study were published in the scientific journal Cancer, Epidemiology, Biomarkers and Prevention in May of 2009.
Screening Breast MRI in Women at Increased Risk for Breast Cancer: A Validation Study: This study is evaluating the use of screening breast MRI in women with an increased risk for breast cancer to understand how often it leads to the use of other screening methods and biopsy as well as to evaluate psychological distress related to having a breast MRI. This study is currently closed to accrual. Follow-up is ongoing.
