The COMET Study is the nation’s first prospective, randomized clinical trial aimed at resolving an ongoing debate about the best way to manage “low-risk” DCIS (Ductal Carcinoma In Situ), also known as “stage zero” breast cancer.

“This is a trial whose time has come. Many of us have felt for two decades that this study needed to be done, but we needed to get doctors and patients to the right point emotionally where it could go forward.” – Otis Brawley, chief medical officer of the American Cancer Society. Waiting and watching with ‘Stage 0’ breast cancer put to nationwide test

Some members of the COMET team

The COMET team hopes the study will show that active surveillance is equally as safe and effective as surgery for women with low-risk DCIS.

“The same kind of active surveillance approach is taken in prostate, thyroid, and other slow-growing, non-invasive cancer types.” – Ann Partridge, COMET co-principal investigator, MD, MPH, Medical Oncologist, Dana-Farber Cancer Institute

“Our study is designed to answer: Does every woman need an operation for a condition that’s non-fatal? What are the patient concerns, outcomes, and issues that arise from having DCIS? And finally how do women make their decisions for treatment?” – Alastair M. Thompson, COMET co-principal investigator , MD, Professor, Breast Surgical Oncology, University of Texas MD Anderson

“Without evidence from the COMET Study, physicians and patients will never learn if Active Surveillance is a reasonable and safe option. Given that low-risk DCIS is not life-threatening, we believe this study will help women make confident, informed treatment decisions that align with their personal preferences.” –  COMET Patient Leadership Team (PLT): Desiree Basila, Donna Pinto, Deborah Collyar, Liz Frank

“It is important to recognize that lack of surgery does not mean no care – ‘active surveillance’ is now an accepted management strategy for some cases of low grade prostate cancer. Our treatments come with real long term side effects and toxicity. The COMET study is a step in the right direction to help determine which patients may safely avoid aggressive treatment.” – Deanna J. Attai, M.D., Assistant Clinical Professor of Surgery at the David Geffen School of Medicine at UCLA and COMET Stakeholder Advisory Board member.

In this video, Dr. Shelley Hwang and patient advocate Donna Pinto discuss physician and patient perspectives about DCIS and why the COMET Study is important:

What is COMET?

The COMET Study was awarded $13.4 million in funding 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.

COMET stands for Comparison of Operative to Monitoring and Endocrine Therapy for low-risk ductal carcinoma in situ (DCIS).

The study is currently enrolling patients newly diagnosed with low-risk DCIS at 100 cancer centers throughout the U.S. Nine hundred women will be randomized to receive one of two treatment approaches:

1. Current standard of care (surgery, radiation and/or endocrine therapy)
2. Careful monitoring (Active Surveillance) with mammograms every 6 months and physical exams every 12 months. Endocrine therapy is optional.

Why is the COMET Study urgently needed?

• There is a growing concern that low-risk DCIS is being over-treated.
• Retrospective trials indicate that 70-80% of DCIS cases may be low-risk and may never develop to invasive cancer or a future DCIS if left untreated and carefully monitored.
• Current uncertainty and disagreement in the medical community about DCIS contributes to patient confusion, fear, and anxiety.
• Results of this study may help more physicians feel confident in offering patients active surveillance as a safe treatment choice for low-risk DCIS.
• Patients may experience a better quality of life knowing that they are being monitored carefully while avoiding potentially unnecessary physical, emotional and financial burdens.

What is “low-risk” DCIS?

DCIS that may have the lowest chance of becoming invasive cancer is called low-risk DCIS. Low-risk DCIS is generally thought to be DCIS that is grade I or grade II, sensitive to hormones, and does not cause symptoms.

There is growing evidence suggesting that low-risk DCIS grows so slowly that it would never cause health problems during a woman’s lifetime. For this type of DCIS, surgery and radiation may have very little or no benefit. – Read more about Risk and Making Decisions.

“This study will provide so many answers to questions about DCIS that are critical to resolve.” — Principal Investigator E. Shelley Hwang, M.D., Chief of Breast Surgery, Duke Cancer Institute

Who is a candidate for COMET?

• Women 40 years or older with low-risk DCIS (low-intermediate grade)
• No personal history of breast cancer or prior treatment of DCIS
• For more information on eligibility, contact Tom Lynch, COMET Project Manager: thomas.lynch2@duke.edu , or visit DCISoptions.org

Where is COMET being offered?

• Partnering with The Alliance for Clinical Trials in Oncology, COMET aims to recruit 900 women at 100 medical centers nationwide
• Locations are listed here — scroll down to    Show 99 Study Locations
• For more information, contact Tom Lynch, thomas.lynch2@duke.edu

“This study is very exciting, the next big frontier in breast cancer treatment with no surgery. We’re trying to change our care and perception of care with less aggressive treatment.” — Dr. Wen Liang,  Seeking less aggressive breast cancer treatment, Anne Arundel Medical Center takes part in clinical trial

Are their similar studies in other countries?

• Yes —LORIS (UK) and LORD (Netherlands)
• PRECISION is an international initiative which will combine data from three trials

“The COMET Study is long over due for women like me (diagnosed with low-risk DCIS). This trial will help thousands of women for years to come make difficult treatment decisions based in research and reassurance rather than uncertainty, fear and concerns of potential over-treatment.” — Donna Pinto, DCIS 411