Under the direction of a Duke Cancer Institute investigator, the first large U.S. study aimed at resolving an ongoing debate about the best way to treat an early sign of breast cancer will launch later this year.
The study, entitled COMET (Comparison of Operative to Medical Endocrine Therapy) for low-risk ductal carcinoma in situ, received funding through a $13.4 million, five-year award from the Patient-Centered Outcomes Research Institute (PCORI), an independent, nonprofit organization authorized by Congress in 2010 to support research that enlightens health care decisions.
Principal investigator E. Shelley Hwang, M.D., chief of breast surgery at the Duke Cancer Institute and vice chair of research in the Duke University Department of Surgery, will lead the study through the cooperative group, The Alliance for Clinical Trials in Oncology. The research will focus on ductal carcinoma in situ, or DCIS, which is a small cluster of abnormal cells in the breast ducts that has not spread to surrounding tissue.
In recent years, physicians and researchers have questioned whether those treatments are necessary in all cases, given that DCIS lesions do not grow rapidly or spread in the majority of women with the diagnosis. Treatment can result in side effects, including long-term pain and altered body image, along with significant financial costs to both patients and the health care system. Actively monitoring many of these patients has been recommended as an alternative if research demonstrates it is safe and effective.
"This will be a definitive clinical trial that will help set the course for future DCIS treatment," said Hwang, who has been a leading voice in the national debate calling for a more informed approach to treating DCIS. "It is based on what we are discovering about the tremendous variety we see even in one disease such as DCIS, and how we must design our future treatments to more precisely reflect those differences."
Hwang will work with co-principal investigators Alastair M. Thompson, M.D., from The University of Texas MD Anderson Cancer Center and Ann H. Partridge, M.D., from Dana-Farber Cancer Institute, partnering with The Alliance for Clinical Trials in Oncology.
The study will enroll 900 patients diagnosed with low-risk DCIS from 100 cancer centers throughout the U.S., with enrollment slated to begin later this year. The trial will take four years to accrue all patients, with follow-up and analysis to continue for at least five years.
Women with a DCIS diagnosis who participate in the study will be randomized to receive one of two treatment approaches: The current standard of care consisting of surgery and radiation therapy, or careful monitoring with mammograms and physical exams every six months.
"Anyone whose DCIS progresses would be immediately treated with standard therapy," Hwang said. "When detected early in this way, the outlook for long-term survival and even a cure is excellent."
Hwang said the study would 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 deters its growth.
The study is also designed to collaborate closely with a similar trial that was initiated last year in Europe, providing the ability to combine findings that will then strengthen the statistical conclusions globally.
"This study will provide so many answers to questions that are critical to resolve," Hwang said. "One of the key features is the assessment of patient-reported outcomes with each approach, as we believe how patients view their disease and their care must be central to any advances in cancer treatment." The funding award for the DCIS study has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.