Study seeks best way to manage breast ‘pre-cancer’

Is the best way to treat an early precursor to breast cancer no treatment at all? That’s what MD Anderson researchers and allied institutions will try to determine in a clinical trial of women with ductal carcinoma in situ, or DCIS, a small cluster of abnormal cells in the milk ducts that hasn’t spread into any normal surrounding breast tissue. DCIS isn’t life-threatening, but having DCIS can increase the risk of developing an invasive breast cancer later on.

The study is funded with 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.

Often referred to as “stage 0” breast cancer, DCIS is diagnosed with mammography or other screening methods in more than 60,000 U.S. women each year. It’s generally treated similarly to other more advanced breast cancers, with surgery and radiation.

Recently, physicians and researchers have begun to question if these treatments are necessary in all cases, given that DCIS does not spread in the majority of patients, and surgery and radiation are costly and can cause side effects such as pain and altered body image. Actively monitoring many of these patients has been recommended as an alternative if research demonstrates it’s safe and effective.

The study’s goal is to determine whether some women with DCIS could be effectively managed with surveillance alone.

“Our study is designed to answer: does every woman need an operation for a condition that’s nonfatal; what are the patient concerns, outcomes and issues that arise from DCIS, and finally, how do women make their decisions for treatment?” explains Alastair Thompson, M.D., professor of Breast Surgical Oncology and the study’s co-principal investigator.

Thompson will work with investigators from the Duke Cancer Institute in North Carolina and Dana-Farber Cancer Institute in Boston, in partnership with the Alliance for Clinical Trials in Oncology, a national clinical trials network sponsored by the National Cancer Institute that consists of about 10,000 cancer specialists at hospitals, medical centers, and community clinics across the United States and Canada.

The study will enroll 900 patients diagnosed with low-risk DCIS from 100 cancer centers throughout the country, with enrollment slated to begin later this year. The enrollment period lasts two years, with follow-up and analysis of patients to continue for at least five years.

Participants will be randomized to receive one of two treatment approaches: either surgery with or without radiation, or careful monitoring with mammograms and physical exams every six months. Both groups may also opt for endocrine therapy, which blocks hormones that feed the growth of some breast tumors.

The study will provide data about the best candidates for active surveillance, and will create a “bank” of medical images and cell samples to provide further knowledge about how DCIS behaves at the molecular level. This will help scientists learn what drives and inhibits the growth of DCIS.

The award funding this study has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.

For more information, visit MD Anderson’s website.