Study Hopes to Resolve Questions About Management of Pre-Cancers of the Breast

Later this year, the first large US study seeking to find the best way to treat an early sign of breast cancer will be launched under the direction of E. Shelley Hwang, MD, chief of breast surgery at the Duke Cancer Institute. She will lead the study, Comparison of Operative to Medical Endocrine Therapy (COMET), through the cooperative Alliance for Clinical Trials in Oncology. COMET will study ductal carcinoma in situ (DCIS), which is a small cluster of abnormal cells in the breast ducts that has not spread to surrounding tissue.

DCIS is currently diagnosed annually in about 60,000 women in the United States and is treated similarly to more advanced breast cancers with surgery and radiation therapy. Physicians and researchers have questioned whether those treatments are necessary in all cases given that DCIS lesions do not grow rapidly or spread in most women with the diagnosis. Treatment can cause side effects and lead to significant personal and societal costs. The study will show if actively monitoring many of these patients is a potentially alternative treatment.

Dr. Hwang, who has been a leading voice in the national debate calling for a more informed approach to DCIS treatment, expects the trial to help set the course for future DCIS treatment. She will work with Alastair M. Thompson, MD, from the University of Texas MD Anderson Cancer Center, and Ann H. Partridge, MD, from Dana-Farber Cancer Institute. The study will enroll 900 patients diagnosed with low-risk DCIS from 100 cancer centers through the United States. It will take 4 years to accrue all patients; follow-up and analysis will continue for at least 5 years. The study will provide data about the best candidates for active surveillance and create a repository of imaging and cell samples to advance knowledge into the molecular biology of DCIS and what fuels or slows its growth.

Women with DCIS who participate in the study will be randomized to receive one of two treatment approaches: the current standard-of-care of surgery and radiation therapy or careful monitoring with mammograms and physical exams every 6 months. Any patient whose DCIS progresses would be immediately treated with standard therapy.

The study was funded through a $13.4 million, 5-year award from the Patient-Centered Outcomes Research Institute, an independent, nonprofit organization authorized by Congress to support research enlightening health care decisions.