Is the best treatment for some women diagnosed with a potential precursor to breast cancer no treatment at all? That is what investigators at Dana-Farber Cancer Institute and allied institutions will try to determine with a $13.3 million funding award from the Patient-Centered Outcomes Research Institute (PCORI).
Approximately 60,000 women in the United States are diagnosed annually with ductal carcinoma in situ (DCIS), a pre-invasive condition, which lacks the potential to spread and cause illness unless it undergoes progression to invasive cancer. DCIS is conventionally treated with surgery, either a mastectomy or lumpectomy, often in combination with radiation. Side effects of these therapies can include long-term pain, worry, altered body image, or rarely, secondary cancers.
With the funding award from PCORI, researchers will launch a clinical trial to gather evidence and help patients consider the range of treatment choices for DCIS, including standard therapies as well as surveillance. The goal of the study will be to determine whether some groups of patients with DCIS who do not benefit from standard treatment, could be effectively managed with surveillance alone.
“The majority of women diagnosed with DCIS will not develop invasive cancer, meaning that many women are currently being treated with minimal to no potential benefits,” said Ann Partridge, MD, MPH, a senior physician in the Susan F. Smith Center for Women’s Cancers at Dana-Farber and study co-principal investigator. “Our study will evaluate disease and quality of life outcomes among women with newly diagnosed, low-risk DCIS who undergo active surveillance (i.e., careful follow-up for changes in the breast), compared to women who undergo standard treatment.”
Patients participating in the trial will be randomly assigned to either a standard care group, who will choose between currently recommended treatment options including surgery and radiation, or a surveillance group that will be monitored closely, with surgery or radiation only upon progression of disease. Patients in both the standard care group and active surveillance groups can choose to receive endocrine therapy, which blocks hormones that fuel the growth of some breast tumors. Study participants will be recruited at 100 participating study sites during the 48-month recruitment period.
Investigators will 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 rates, survival periods, and quality-of-life between standard care and surveillance groups.
Dana-Farber and its partners in the trial, Duke Medical Center and MD Anderson Cancer Center, were selected through a highly competitive review process in which patients, caregivers, and other stakeholders joined scientists to evaluate the proposals. Their award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract. Shelley Hwang, MD, of Duke is the study’s principal investigator and Dr. Alastair M. Thompson, MD of MD Anderson Cancer Center will serve with Partridge as co-principal investigators.
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.