• E Shelley Hwang, Terry Hyslop, Thomas Lynch, Marc D Ryser, Anna Weiss, Anna Wolf, Kelsey Norris, Meredith Witten, Lars Grimm, Stuart Schnitt, Sunil Badve, Rachel Factor, Elizabeth Frank, Deborah Collyar, Desiree Basila, Donna Pinto, Mark A Watson, Robert West, Louise Davies, Jenny L Donovan, Ayako Shimada, Yutong Li, Yan Li, Antonia V Bennett, Shoshana Rosenberg, Jeffrey Marks, Eric Winer, Marc Boisvert, Armando Giuliano, Kelsey E Larson, Kathleen Yost, Priscilla F McAuliffe, Amy Krie, Nina Tamirisa, Lisa A Carey, Alastair M Thompson, Ann H Partridge, and COMET Study Investigators.
• Department of Surgery, Duke University, Durham, North Carolina.
• JAMA. 2024 Dec 12.

ImportanceActive monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown.ObjectiveTo compare rates of invasive cancer in patients with low-risk DCIS receiving active monitoring vs guideline-concordant care.Design, Setting, And ParticipantsProspective, randomized noninferiority trial enrolling 995 women aged 40 years or older with a new diagnosis of hormone receptor-positive grade 1 or grade 2 DCIS without invasive cancer at 100 US Alliance Cancer Cooperative Group clinical trial sites from 2017 to 2023.InterventionsParticipants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical examination; n = 484) or guideline-concordant care (surgery with or without radiation therapy; n = 473).Main Outcomes And MeasuresThe primary outcome was 2-year cumulative risk of ipsilateral invasive cancer diagnosis, according to planned intention-to-treat and per-protocol analyses, with a noninferiority bound of 0.05%.ResultsThe median age of the 957 participants analyzed was 63.6 (95% CI, 55.5-70.5) years in the guideline-concordant care group and 63.7 (95% CI, 60.0-71.6) years in the active monitoring group. Overall, 15.7% of participants were Black and 75.0% were White. In this prespecified primary analysis, median follow-up was 36.9 months; 346 patients had surgery for DCIS, 264 in the guideline-concordant care group and 82 in the active monitoring group. Forty-six women were diagnosed with invasive cancer, 19 in the active monitoring group and 27 in the guideline-concordant care group. The 2-year Kaplan-Meier cumulative rate of ipsilateral invasive cancer was 4.2% in the active monitoring group vs 5.9% in the guideline-concordant care group, a difference of -1.7% (upper limit of the 95% CI, 0.95%), indicating that active monitoring is not inferior to guideline-concordant care. Invasive tumor characteristics did not differ significantly between groups.Conclusions And RelevanceWomen with low-risk DCIS randomized to active monitoring did not have a higher rate of invasive cancer in the same breast at 2 years compared with those randomized to guideline-concordant care.Trial RegistrationClinicalTrials.gov Identifier: NCT02926911.

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