Lauded Study Finds Surgery May Not Be Necessary for Precancerous Breast Condition

Thomas Jefferson University biostatistician Terry Hyslop designed a trial showing active monitoring to be as effective as surgery for ductal carcinoma in situ.

As mammography technology improves, precancerous ductal carcinoma in situ (DCIS) has been identified earlier. DCIS rarely becomes invasive cancer, because its abnormal cells are encapsulated within the breast’s milk ducts. But surgery is the standard of care.

Researchers have been curious if a less invasive approach — mammography plus physical exams — can be as effective as surgery. But recruiting patients for randomized clinical trials proved difficult.

“People dropped out of European trials; they didn’t agree to be randomized — they had specific ideas about treatment,” said Terry Hyslop, Ph.D., director of cancer health equity at Sidney Kimmel Comprehensive Cancer Center – Jefferson Health. “We wondered, ‘Can we design it so patient preference becomes part of the randomization?’”

Dr. Hyslop is the lead statistician for the COMET (Comparing an Operation to Monitoring, With or Without Endocrine Therapy for Low-Risk DCIS) trial. Her patient-centric design randomized 957 women to active monitoring or surgery groups, with the option to switch groups.

COMET showed that active monitoring is comparable to surgery after two years. Active monitoring could become the standard of care, keeping countless women from undergoing surgery unnecessarily.

Conducted across 100 Alliance for Clinical Trials in Oncology Foundation Trials member sites between June 2017 and January 2023, the trial is ongoing, to gauge effectiveness over time.

JAMA’s editors named COMET among nine studies in its Research of the Year 2025 publication, deeming it “the most impactful, the most newsworthy, and the most novel.” “We were thrilled,” Dr. Hyslop said. “It’s gratifying that it might become the standard, eventually.”

To learn more, visit Research.Jefferson.edu

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