Durham, North Carolina
Mary and Deryl Hart Distinguished Professor and Vice Chair of Research
Chief of Breast Surgery
Department of Surgery
Investigating new treatments for patients with low-risk ductal carcinoma in situ.
Ductal carcinoma in situ (DCIS) is a non-malignant condition where a mass of abnormal cells is found inside the milk ducts of the breast. It is diagnosed in over 60,000 women each year in the United States. Without treatment, many DCIS cases will never progress to invasive cancer, but almost all women who are diagnosed are treated with surgery and/or radiation. Many doctors and researchers believe that it might be possible to monitor DCIS rather than operate right away, but they are unable to do so without better evidence. The Comparing an Operation to Monitoring, with or without Endocrine Therapy study (COMET, NCT02926911) study is designed to answer this question. Women with low-risk DCIS are randomized into two groups: those who undergo surgery and those who undergo active monitoring (AM) with regular follow-up exams and mammograms. Since 2017, the COMET study has enrolled almost 1,000 women.
The goals of the current year are to continue monitoring outcomes of study participants and verifying collection of specimens (blood and tissue) as well as imaging at regular intervals. Dr. Hwang and her team anticipate the COMET study will demonstrate that outcomes for women with low-risk DCIS who undergo AM are similar to those who undergo surgery. Furthermore, they are hopeful that analysis of blood and tissue samples and imaging will allow them to differentiate DCIS that progresses to invasive cancer from DCIS that does not. Together, these efforts may change the way that low-risk DCIS is treated.
Dr. Shelley Hwang, MD, MPH is the Mary and Deryl Hart Distinguished Professor of Surgical Oncology and Radiology, Vice Chair of Research and Chief of Breast Surgery for the Duke Department of Surgery. She also serves as Co-Lead for the Women’s Cancer Program at the Duke University Comprehensive Cancer Center. Her research focus includes breast cancer prevention, identifying less invasive treatments for early-stage breast cancers including ductal carcinoma in situ (DCIS), and addressing and mitigating health care disparities in breast cancer.
Dr. Hwang is an experienced clinical trialist with an interest in both the biology and treatment of early-stage breast cancer. She has led large, multidisciplinary clinical teams of breast cancer providers, advocates, and researchers, and currently leads a clinical group of nine full time breast surgeons successfully engaged and committed to clinical research who provide a strong clinical patient base and engaged collaboration for translational projects. She is a nationally recognized figure in pre-invasive disease and leads or participates in several collaborative efforts on this topic including the Cancer Research UK “Precision” study and the randomized trial of DCIS active surveillance known as COMET. She is the surgical Principal Investigator of the Duke National Cancer Institute (NCI) National Clinical Trials Network, which promotes and oversees recruitment to cooperative group trials. She also serves as a member of the NCI Breast Cancer Steering Committee and the National Comprehensive Cancer Network Screening Guidelines Committee.
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