Titles and Affiliations

Professor and Vice Chair of Research, Department of Surgery
Chief, Breast Surgical Oncology
Interim Director, Duke Breast Oncology Program

Research area

Identifying markers that can detect when pre-invasive cancer progresses to invasive disease.


Widespread access to mammographic screening has resulted in more than a five-fold increase in detection of ductal carcinoma in situ (DCIS)—a premalignant form of breast cancer that may or may not progress to invasive breast cancer. Despite this, there has not been a corresponding reduction in the incidence of invasive or metastatic breast cancer (MBC). Dr. Hwang aims to personalize treatment recommendations for women with DCIS based on the biology of their tumor. Her goal is to identify biomarkers in blood and tissue that could predict a low versus high risk of progression to invasive cancer. Her findings have the potential to spare many women with DCIS from undergoing unnecessary treatments such as surgery and radiation.

Progress Thus Far

Previous BCRF funding enabled the collection of tumor and blood samples from the COMET Trial (Comparison of Operative to Monitoring and Endocrine Therapy), a clinical trial for women with low-risk DCIS that compares active surveillance (AS)—a strategy to monitor early-stage disease—to usual care, which includes surgery, endocrine therapy and possibly radiation. Dr. Hwang has created a biorepository of COMET participant samples that includes over 1,500 mammograms, 581 tissue samples, and 587 blood samples. In the last year, her team has added samples from an additional 174 DCIS patients, for a current total of 853 patients. From analysis of these samples, she has identified certain genetic features of DCIS tumors that may predict the likelihood of progression to invasive breast cancer.  

What's next

Dr. Hwang and her colleagues will continue building the biospecimen repository with a target accrual goal of 1,200 DCIS samples. She is testing the potential clinical utility of two circulating biomarkers as predictors for occult invasive cancer at the time of DCIS diagnosis. They are also developing a method to determine the age of DCIS lesions. Lesion age provides an indicator as to whether it is slow growing (old lesion) or aggressive (young lesion), which is valuable knowledge for patients considering active monitoring versus surgery.  


Dr. Shelley Hwang, MD, MPH is a Professor of Surgical Oncology, Vice Chair of Research and Chief of Breast Surgery for the Duke Department of Surgery and 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 understanding the genetic and stromal determinants of cancer progression. Dr. Hwang is an experienced clinical trialist with an interest in both the biology and treatment early stage breast cancer including DCIS. She is lead investigator (PI) of a national cooperative group study through the ALLIANCE evaluating the role of preoperative systemic hormonal therapy for DCIS. She is also surgical PI of the Duke NCI National Clinical Trials Network, which promotes and oversees recruitment to cooperative group trials. She serves as a member of the National Cancer Institute Breast Cancer Steering Committee and the NCCN Screening Guidelines Committee. Other interests of the Hwang group include the evolutionary role of tumor and environmental heterogeneity in driving DCIS progression and the impact of the breast density, microenvironmental factors, and the stromal immune infiltrate in determining breast cancer phenotype and response to chemotherapy. Her team incorportates computational models of cancer progression, and have developed progression models for invasive breast cancer.

BCRF Investigator Since


Donor Recognition

The Tanger Factory Outlets Award

Areas of Focus