E-Newsletter - March 2016

alliance researcher approved for $13M funding Award for patient-centered research

An Alliance researcher has been approved for a multi-year funding award from the Patient-Centered Outcomes Research Institute (PCORI) to fund comparative effectiveness research that will study active surveillance versus traditional treatment options, such as surgery and radiation, for patients diagnosed with ductal carcinoma in situ (DCIS). Shelley Hwang, MD, MPH, a surgical oncologist from Duke University Medical Center is a member of the Alliance American College of Surgeons Clinical Research Program’s Cancer Care Delivery Research Committee. She also is a Professor of Surgery in the Department of Surgery/Division of Advanced Oncologic and GI Surgery at Duke University.

The PCORI award will fund “Comparison of Operative versus Medical Endocrine Therapy for Low Risk DCIS: The COMET Trial”  ($13,399,702 over five years). The proposal was sponsored by the Alliance for Clinical Trials in Oncology Foundation.

The primary objective of the study is to assess whether the invasive cancer rate in the affected breast is the same for women undergoing standard care compared to surveillance. Secondary objectives will be to compare mastectomy rate, survival endpoints, and quality-of-life endpoints between standard care and surveillance groups.

Dr. Hwang and her team have designed a large pragmatic randomized trial comparing operative to medical endocrine therapy for low-risk DCIS (COMET trial). The study will compare patients with low-risk DCIS who are randomized to receive either standard care or surveillance. Patients randomized to the standard care group will choose between currently recommended treatment options including surgery and radiation; those in the surveillance group will be monitored closely, with surgery or radiation only upon progression of disease. Patients in both groups will be free to decide whether to choose endocrine therapy. Study participants will be recruited at 100 participating study sites during the 48-month recruitment period. The study team will recruit 446 patients to each study arm. The goal of the study is to gather evidence to help future patients consider the range of treatment choices for DCIS, including standard therapies as well as surveillance. The study team will seek to determine whether there are some groups of patients with DCIS who do not benefit from standard treatment and who could thus be managed with surveillance.

The study was selected for PCORI funding through a highly competitive review process in which patients, clinicians, and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage patients and other stakeholders, and their methodological rigor among other criteria. The award to Dr. Hwang has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. Click here to learn more about the study.

PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org or http://www.pcori.org/funding/opportunities.

Photo credit: Shawn Rocco, Duke Medicine


For other articles in the March issue of the Alliance E-News newsletter, see below.