Carolina Breast Cancer Study enrolls record 3,000 participants
Nov. 25, 2013
Researchers leading the Carolina Breast Cancer Study (CBCS) have enrolled the 3,000th participant for the study’s third phase, making it the largest-ever population-based study of breast cancer in North Carolina and one of the largest in the world. This milestone completes enrollment and initiates the five- year follow-up.
CBCS is conducted by the UNC Lineberger Comprehensive Cancer Center, UNC Gillings School of Global Public Health and UNC School of Medicine faculty with funding from the University Cancer Research Fund, the National Cancer Institute, UNC Breast SPORE and Susan G. Komen for the Cure®.
Launched in 1993, the study aims to improve understanding of breast cancer, including why the disease’s fatality rate is higher in African-American women. Phase III will focus specifically on how treatment decisions, access to care, and financial or geographic barriers make an impact upon breast cancer outcomes and whether these outcomes are predictable or altered by genetic breast cancer subtypes.
This recent enrollment milestone puts the total number of CBCS participants at more than 7,300.
The latest study phase was named after the late Jeanne Hopkins Lucas. The first African-American woman to become a North Carolina state senator, Lucas died of breast cancer in 2007.
Participants were identified from a list of newly diagnosed breast cancer patients provided by the North Carolina Central Cancer Registry (NCCCR), which identifies and registers all new cancer diagnoses in the state. Participants were then selected through a scientifically sound, randomized process, and physicians were notified of the study’s intent to contact their patient.
“We are so grateful for the tremendous interest and cooperation from the women approached for the study and our network of physicians and health care providers across the state to connect us with their patients,” said Andy Olshan, PhD, professor and chair of epidemiology at the Gillings School and the study’s principal investigator.
Olshan also is associate director of population sciences at UNC Lineberger.
Study participants were interviewed in their homes by trained nurses regarding breast cancer risk factors, quality of life and medical history. A DNA blood or mouth-rinse sample also was taken to help determine genetic factors that might change women’s risk of getting breast cancer or change their response to therapy. Tumor samples also were obtained to understand molecular changes in the individual tumors.
Researchers also obtained permission to access participants’ medical records relating to breast cancer diagnosis and treatment, and to follow participants for at least five years. All data will be held in strict confidence.
This landmark study, initiated 20 years ago by UNC Lineberger in the Breast Cancer SPORE grant, has changed the world’s thinking about breast cancer and associated risk factors.
“Dividing the diagnosis of breast cancer into at least four subtypes allowed the first phases of CBCS to determine that younger African-American women were more likely to have an aggressive breast cancer subtype,” said Shelton Earp, MD, director of UNC Lineberger. “The findings also showed that outcomes and even risk factors such as childbearing, weight and alcohol differed by subtype. CBCS III will delve more deeply into the molecular genetics of subtypes in younger and older women and will follow women and their treatment. The findings will vastly improve our understanding of what works and what does not in community settings.”
Olshan said the data would help explain how genetic factors in an individual’s tumor would interact with treatment and access to health care.
“We can ask questions as to what influences survival, complications and quality of life,” Olshan said. “Specific modifiable factors such as breastfeeding and physical activity that could lower a women’s risk of breast cancer are also being investigated.”
The study also aims to further investigate subtypes of breast cancer that may be associated with different risk factor and prognosis profiles, continuing discoveries made in earlier phases of the study.
“CBCS participants are the real heroes; they will be contributing to changing our understanding of breast cancer therapy for their sisters and daughters,” said Mary Beth Bell, MPH, current study manager. Bell said the research team held four symposia this fall – in Wilmington, Greenville, Concord and Chapel Hill – to celebrate the 3000th participant and to let enrollees learn more about the study.
Data from earlier CBCS research were key to a 2006 finding by a UNC Lineberger team that included the late Robert Millikan, PhD, DVM, formerly a distinguished professor of epidemiology at the Gillings School; Charles Perou, PhD, professor of genetics and pathology; and Lisa Carey, MD, physician-in chief of the N.C. Cancer Hospital and chief of the Division of Hematology and Oncology in the Department of Medicine.
They found that premenopausal African-American breast cancer patients have the highest prevalence of a subtype of breast cancer called “basal-like” cancer.