Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS
NCT ID: NCT02926911
Last Updated: 2026-01-27
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
997 participants
INTERVENTIONAL
2017-02-22
2030-07-31
Brief Summary
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Detailed Description
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The overarching hypothesis of the study is that management of low-risk DCIS using an active monitoring (AM) approach does not yield inferior cancer or quality of life outcomes compared to surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Surgery
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)
Surgery
Surgery +/- radiation choice for endocrine therapy
Active Monitoring
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Active Monitoring
Choice for endocrine therapy
Interventions
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Surgery
Surgery +/- radiation choice for endocrine therapy
Active Monitoring
Choice for endocrine therapy
Eligibility Criteria
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Inclusion Criteria
* A patient who has had a lumpectomy or partial mastectomy with margins positive for DCIS (i.e. \<2mm/ink on tumor) as part of their treatment for a current DCIS diagnosis is also eligible (post-excision bilateral mammogram required at enrollment to establish a new baseline)
* No previous DCIS or invasive breast cancer in ipsilateral breast 5 years prior to current DCIS diagnosis
* 40 years of age or older at time of DCIS diagnosis
* ECOG performance status 0 or 1
* No contraindication for surgery
* Baseline imaging (must include dimensions):
* Unilateral DCIS: contralateral normal mammogram ≤ 6 months of registration and ipsilateral breast imaging ≤ 120 days of registration (must include ipsilateral mammogram; can also include ultrasound or breast MRI)
* Bilateral DCIS: bilateral breast imaging ≤ 120 days of registration (must include bilateral mammogram; can also include ultrasound or breast MRI)
* DCIS s/p lumpectomy: post excision mammogram on side of excision ≤ 60 days of registration
* Pathologic criteria:
* Any grade I DCIS (irrespective of necrosis/comedonecrosis)
* Any grade II DCIS (irrespective of necrosis/comedonecrosis)
* Absence of invasion or microinvasion
* Diagnosis of DCIS confirmed on core needle biopsy, vacuum-assisted or surgery ≤ 120 days of registration
* ER(+) and/or PR(+) by IHC (≥ 10% staining or Allred score ≥ 4) unless atypia verging on DCIS in which case biomarker criterion does not apply
* HER2 0, 1+, or 2+ by IHC if HER2 testing is performed
* Histology slides reviewed and agreement between two clinical pathologists (not required to be at same institution) that pathology fulfills COMET eligibility criteria. In cases of disagreement between the two pathology reviews about whether or not a case fulfills the eligibility criteria, a third pathology review will be required.
* At least two sites of biopsy for those cases where individual mammographic extent of calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling pathology eligibility criteria (ER/PR testing required for second biopsy)
* Amenable to follow up examinations
* Ability to read, understand and evaluate study materials and willingness to sign a written informed consent document
* Reads and speaks Spanish or English
Exclusion Criteria
* Grade III DCIS
* Concurrent diagnosis of invasive or microinvasive breast cancer in either breast
* Documented mass on examination or mass/hypoechoic area on imaging at site of DCIS prior to biopsy yielding diagnosis of DCIS, with exception of: subsequent lumpectomy or partial mastectomy (with positive DCIS margins i.e. \<2mm/ink on tumor) followed by a post-surgery MMG; fibroadenoma at a distinct/separate site from site of DCIS; or diagnosis of mass/hypoechoic area as a cyst or a papilloma. In cases of uncertainty about whether the mass was present on physical examination prior to biopsy, the following criteria should be applied: if mammogram noting abnormal findings is diagnostic MMG = symptomatic/if mammogram noting abnormal findings is screening MMG = asymptomatic. If a patient has a mass on imaging that is biopsied (worked-up) and does not show invasive breast cancer, they are eligible. If a patient has a mass on initial MMG that is not seen on subsequent MMG, they are eligible (if initial mass occurred due to additional work-up).
* Any color/bloody nipple discharge (ipsilateral breast)
* Mammographic finding of BIRADS 4 or greater within 6 months prior to registration at site of breast other than that of known DCIS, without pathologic assessment
* Use of investigational cancer agents within 6 weeks prior to diagnosis of DCIS
* Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
* Pregnancy. If a woman has been confirmed as pregnant, she will not be eligible to take part in the trial. If she suspects there is a chance that she may be pregnant, a pregnancy test should be undertaken, although a pregnancy test for all women of child-bearing potential is not mandatory. In addition, if a woman becomes pregnant once registered to the trial, she can continue to be followed (endocrine therapy is not a mandatory requirement of the study)
* Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene use in the 6 months prior to registration
* Current use of exogenous hormones (i.e. oral progesterone)
40 Years
99 Years
FEMALE
No
Sponsors
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Duke University
OTHER
Dana-Farber Cancer Institute
OTHER
New York University
OTHER
Washington University School of Medicine
OTHER
Patient-Centered Outcomes Research Institute
OTHER
M.D. Anderson Cancer Center
OTHER
Rising Tide Foundation
OTHER
Breast Cancer Research Foundation
OTHER
Alliance Foundation Trials, LLC.
OTHER
Responsible Party
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Principal Investigators
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Shelley Hwang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Duke University
Ann Partridge, MD, MPH
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Alastair Thompson, MD
Role: STUDY_CHAIR
Baylor College of Medicine
Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
Mayo Clinic
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Kaiser Permanente Medical Center
Vallejo, California, United States
Colorado Cancer Research Program
Denver, Colorado, United States
Saint Joseph Hospital- Cancer Centers of Colorado
Lafayette, Colorado, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Memorial Healthcare System
Hollywood, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
Kootenai Health
Post Falls, Idaho, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Ingalls Memorial Hospital
Harvey, Illinois, United States
Illinois Cancer Care
Peoria, Illinois, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Medical Oncology and Hematology Associates - Des Moines
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
St. Elizabeth Healthcare Edgewood
Edgewood, Kentucky, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Eastern Maine Medical Center Cancer Care
Brewer, Maine, United States
Maine Center for Cancer Medicine-Scarborough
Scarborough, Maine, United States
New England Cancer Specialists
Scarborough, Maine, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
Beaumont NCORP
Royal Oak, Michigan, United States
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Metro MN Community Oncology Research Consortium (MMCORC)
Saint Louis Park, Minnesota, United States
Washington University - Siteman Cancer Center
St Louis, Missouri, United States
Community Hospital of Anaconda
Anaconda, Montana, United States
Billings Clinic
Billings, Montana, United States
Bozeman Health
Bozeman, Montana, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Center
Missoula, Montana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New Hampshire Oncology Hematology PA
Hooksett, New Hampshire, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Atlantic Health System / Morristown Medical Center
Morristown, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
New York-Presbyterian Weill Cornell Medical Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Novant Health Breast Surgery - Greensboro
Greensboro, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Carolina East Medical Center
New Bern, North Carolina, United States
Rex Cancer Center
Raleigh, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Strecker Cancer Center - Belpre
Belpre, Ohio, United States
Dayton Physicians-Miami Valley Hospital South
Centerville, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Mount Carmel East Hospital
Columbus, Ohio, United States
Columbus Oncology & Hematology INC
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
MidOhio Oncology Hematology, Mark H. Zangmeister Center
Columbus, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Dayton Physicians-Miami Valley Hospital North
Dayton, Ohio, United States
Grady Hospital
Delaware, Ohio, United States
OhioHealth Grady - Delaware Health Center
Delaware, Ohio, United States
Armes Family Cancer Center
Findlay, Ohio, United States
Dayton Physicians-Atrium
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
OhioHealth Mansfield Hospital
Mansfield, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
OhioHealth Marion General Hospital
Marion, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
St. Ann's Hospital
Westerville, Ohio, United States
St. Elizabeth Youngstown Hospital
Youngstown, Ohio, United States
Genesis Health Care System
Zanesville, Ohio, United States
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, United States
Saint Charles Health System
Bend, Oregon, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States
WellSpan Health York Cancer Center
York, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Georgetown Hospital System
Georgetown, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Baptist Cancer Care
Memphis, Tennessee, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Doctors Hospital of Laredo
Laredo, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
The University of Vermont Medical Center
Burlington, Vermont, United States
West Virginia University Medicine
Morgantown, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
ThedaCare Regional Cancer Center -Appleton
Appleton, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Burlington, Wisconsin, United States
Aurora Health Center - Fond du Lac
Fond du Lac, Wisconsin, United States
Aurora Health Care, Germantown Health Center
Germantown, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Grafton, Wisconsin, United States
Saint Vincent Hospital
Green Bay, Wisconsin, United States
BayCare Aurora LLC, Aurora Cancer Care
Green Bay, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Kenosha, Wisconsin, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Aurora Bay Area Medical Group - Cancer Care Clinic
Marinette, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Marinette, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Milwaukee, Wisconsin, United States
Vince Lombardi Cancer Clinic of Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Milwaukee, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Oshkosh, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Racine, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Sheboygan, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Summit, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Two Rivers, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
Wauwatosa, Wisconsin, United States
Aurora Health Care, Aurora Cancer Care
West Allis, Wisconsin, United States
Countries
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References
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Ernster VL, Ballard-Barbash R, Barlow WE, Zheng Y, Weaver DL, Cutter G, Yankaskas BC, Rosenberg R, Carney PA, Kerlikowske K, Taplin SH, Urban N, Geller BM. Detection of ductal carcinoma in situ in women undergoing screening mammography. J Natl Cancer Inst. 2002 Oct 16;94(20):1546-54. doi: 10.1093/jnci/94.20.1546.
Erbas B, Provenzano E, Armes J, Gertig D. The natural history of ductal carcinoma in situ of the breast: a review. Breast Cancer Res Treat. 2006 May;97(2):135-44. doi: 10.1007/s10549-005-9101-z. Epub 2005 Dec 1.
Ozanne EM, Shieh Y, Barnes J, Bouzan C, Hwang ES, Esserman LJ. Characterizing the impact of 25 years of DCIS treatment. Breast Cancer Res Treat. 2011 Aug;129(1):165-73. doi: 10.1007/s10549-011-1430-5. Epub 2011 Mar 9.
Nystrom L, Rutqvist LE, Wall S, Lindgren A, Lindqvist M, Ryden S, Andersson I, Bjurstam N, Fagerberg G, Frisell J, et al. Breast cancer screening with mammography: overview of Swedish randomised trials. Lancet. 1993 Apr 17;341(8851):973-8. doi: 10.1016/0140-6736(93)91067-v.
Partridge AH, Hyslop T, Rosenberg SM, Bennett AV, Drier S, Jonsson M, Shimada A, Li Y, Li Y, Lynch T, Frank E, Collyar D, Basila D, Pinto D, Weiss A, Wolf A, Norris K, Witten M, Boisvert M, Giuliano A, Larson KE, Yost K, McAuliffe PF, Krie A, Tamirisa N, Darai S, Carey L, Thompson A, Hwang ES; COMET Study Consortium. Patient-Reported Outcomes for Low-Risk Ductal Carcinoma In Situ: A Secondary Analysis of the COMET Randomized Clinical Trial. JAMA Oncol. 2025 Mar 1;11(3):300-309. doi: 10.1001/jamaoncol.2024.6556.
Hwang ES, Hyslop T, Lynch T, Ryser MD, Weiss A, Wolf A, Norris K, Witten M, Grimm L, Schnitt S, Badve S, Factor R, Frank E, Collyar D, Basila D, Pinto D, Watson MA, West R, Davies L, Donovan JL, Shimada A, Li Y, Li Y, Bennett AV, Rosenberg S, Marks J, Winer E, Boisvert M, Giuliano A, Larson KE, Yost K, McAuliffe PF, Krie A, Tamirisa N, Carey LA, Thompson AM, Partridge AH; COMET Study Investigators. Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial. JAMA. 2025 Mar 18;333(11):972-980. doi: 10.1001/jama.2024.26698.
Ozanne EM, Maves K, Tramontano AC, Lynch T, Thompson A, Partridge A, Frank E, Collyar D, Basila D, Pinto D, Hyslop T, Ryser MD, Rosenberg S, Hwang ES, Punglia RS. Impact of an online decision support tool for ductal carcinoma in situ (DCIS) using a pre-post design (AFT-25). Breast Cancer Res. 2024 Sep 17;26(1):134. doi: 10.1186/s13058-024-01891-w.
Hwang ES, Hyslop T, Lynch T, Frank E, Pinto D, Basila D, Collyar D, Bennett A, Kaplan C, Rosenberg S, Thompson A, Weiss A, Partridge A. The COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial: a phase III randomised controlled clinical trial for low-risk ductal carcinoma in situ (DCIS). BMJ Open. 2019 Mar 12;9(3):e026797. doi: 10.1136/bmjopen-2018-026797.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AFT-25
Identifier Type: -
Identifier Source: org_study_id
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