AzTrials
AzTrials

DCISCOMETNCT02926911

Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS

A study testing Surgery and Active Monitoring in people with DCIS and Ductal Carcinoma in Situ, run by Alliance Foundation Trials, LLC. at 141 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality… Read more about this study

Who is it for?
Ages 40 to 99 years, women only
Conditions the study is for
DCIS, Ductal Carcinoma in Situ
What is being tested?
Surgery and Active Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
997 participants
Where
141 sitesUnited States
Study dates
22 Feb 2017to Jul 2030
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of unilateral, bilateral, unifocal, multifocal, or multicentric DCIS without invasive breast cancer (date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS) OR: atypia verging on DCIS OR: DCIS + LCIS (mix and/or separate locations in the same breast)
  • 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
Show all 22Show fewer
  • 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

Who cannot join

  • Male DCIS
  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

141 sites in 1 country.

141 sites in 1 country

United States141 sites

  • New Mexico Cancer Care Alliance

    Albuquerque, New Mexico, 87106

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48197

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • ThedaCare Regional Cancer Center -Appleton

    Appleton, Wisconsin, 54911

  • University of Maryland - Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Strecker Cancer Center - Belpre

    Belpre, Ohio, 45714

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Billings Clinic

    Billings, Montana, 59101

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Health

    Bozeman, Montana, 59715

  • Eastern Maine Medical Center Cancer Care

    Brewer, Maine, 04412

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Aurora Health Care, Aurora Cancer Care

    Burlington, Wisconsin, 53105

  • Dayton Physicians-Miami Valley Hospital South

    Centerville, Ohio, 45459

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43202

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus Oncology & Hematology INC

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • MidOhio Oncology Hematology, Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel West Hospital

    Columbus, Ohio, 43223

  • Doctors Hospital

    Columbus, Ohio, 43228

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75235

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Dayton Physicians-Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Grady Hospital

    Delaware, Ohio, 43015

  • OhioHealth Grady - Delaware Health Center

    Delaware, Ohio, 43015

  • Colorado Cancer Research Program

    Denver, Colorado, 80222

  • Medical Oncology and Hematology Associates - Des Moines

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • St. Elizabeth Healthcare Edgewood

    Edgewood, Kentucky, 41017

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Cape Fear Valley Health System

    Fayetteville, North Carolina, 28304

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Aurora Health Center - Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Dayton Physicians-Atrium

    Franklin, Ohio, 45005

  • Georgetown Hospital System

    Georgetown, South Carolina, 29440

  • Aurora Health Care, Germantown Health Center

    Germantown, Wisconsin, 53022

  • Southeastern Medical Oncology Center

    Goldsboro, North Carolina, 27534

  • Aurora Health Care, Aurora Cancer Care

    Grafton, Wisconsin, 53024

  • Cancer Research Consortium of West Michigan

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • BayCare Aurora LLC, Aurora Cancer Care

    Green Bay, Wisconsin, 54311

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Novant Health Breast Surgery - Greensboro

    Greensboro, North Carolina, 27403

  • East Carolina University

    Greenville, North Carolina, 27834

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • New Hampshire Oncology Hematology PA

    Hooksett, New Hampshire, 03106

  • MD Anderson Cancer Center

    Houston, Texas, 60586

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Aurora Health Care, Aurora Cancer Care

    Kenosha, Wisconsin, 49408

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Saint Joseph Hospital- Cancer Centers of Colorado

    Lafayette, Colorado, 80026

  • Doctors Hospital of Laredo

    Laredo, Texas, 78045

  • Cancer Centers of Southwest Oklahoma

    Lawton, Oklahoma, 73505

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Aurora Bay Area Medical Group - Cancer Care Clinic

    Marinette, Wisconsin, 54143

  • Aurora Health Care, Aurora Cancer Care

    Marinette, Wisconsin, 54143

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Baptist Cancer Care

    Memphis, Tennessee, 38120

  • Aurora Health Care, Aurora Cancer Care

    Milwaukee, Wisconsin, 53209

  • Vince Lombardi Cancer Clinic of Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Aurora Health Care, Aurora Cancer Care

    Milwaukee, Wisconsin, 53233

  • Masonic Cancer Center, University of Minnesota

    Minneapolis, Minnesota, 55455

  • Community Medical Center

    Missoula, Montana, 59804

  • West Virginia University Medicine

    Morgantown, Virginia, 26506

  • Atlantic Health System / Morristown Medical Center

    Morristown, New Jersey, 07960

  • Jersey Shore University Medical Center

    Neptune City, New Jersey, 07753

  • Carolina East Medical Center

    New Bern, North Carolina, 28561

  • Smilow Cancer Hospital at Yale-New Haven

    New Haven, Connecticut, 06510

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • New York-Presbyterian Weill Cornell Medical Center

    New York, New York, 10065

  • Mount Sinai Hospital

    New York, New York, 60608

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Sentara Norfolk General Hospital

    Norfolk, Virginia, 23507

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Aurora Health Care, Aurora Cancer Care

    Oshkosh, Wisconsin, 54904

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • Illinois Cancer Care

    Peoria, Illinois, 61615

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Kootenai Health

    Post Falls, Idaho, 83854

  • Rhode Island Hospital

    Providence, Rhode Island, 02906

  • Aurora Health Care, Aurora Cancer Care

    Racine, Wisconsin, 53406

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Beaumont NCORP

    Royal Oak, Michigan, 48073

  • Metro MN Community Oncology Research Consortium (MMCORC)

    Saint Louis Park, Minnesota, 55416

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Maine Center for Cancer Medicine-Scarborough

    Scarborough, Maine, 04074

  • New England Cancer Specialists

    Scarborough, Maine, 04074

  • Aurora Health Care, Aurora Cancer Care

    Sheboygan, Wisconsin, 53081

  • Washington University - Siteman Cancer Center

    St Louis, Missouri, 63110

  • Aurora Health Care, Aurora Cancer Care

    Summit, Wisconsin, 53066

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park

    The Bronx, New York, 10461

  • Aurora Health Care, Aurora Cancer Care

    Two Rivers, Wisconsin, 54241

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Aurora Health Care, Aurora Cancer Care

    Wauwatosa, Wisconsin, 53226

  • Aurora Health Care, Aurora Cancer Care

    West Allis, Wisconsin, 53227

  • St. Ann's Hospital

    Westerville, Ohio, 43081

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • WellSpan Health York Cancer Center

    York, Pennsylvania, 17403

  • St. Elizabeth Youngstown Hospital

    Youngstown, Ohio, 44501

  • Genesis Health Care System

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

This study looks at the risks and benefits of active monitoring (AM) compared to surgery in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.

Read the detailed description

Overdiagnosis and overtreatment resulting from mammographic screening have been estimated to be as high as 1 in 4 patients diagnosed with breast cancer although the absence of standard definitions for measuring overdiagnosis has led to much uncertainty around this estimate. The national health care expenditure resulting from false positive mammograms and breast cancer overdiagnosis has been estimated to approach $4 billion annually. There is general consensus that much of this burden derives from the treatment of DCIS; for those estimated 40,000 women per year whose DCIS may never have progressed even without treatment, medical intervention can only harm. In those women who undergo surgical management of DCIS, there is risk of developing persistent pain at the surgical site, with estimates ranging from 25-68%. Importantly, persistent pain after lumpectomy may be as prevalent as that after total mastectomy. Persistent postsurgical pain is rated by patients as the most troubling symptom, leading to disability and psychological distress, and is often resistant to management. Although prospective population-based data have demonstrated significant patient and surgical focus on pain with remarkably high levels of chronic pain 4 and 9 months after breast surgery, much of these data have been collected in women with invasive cancer, with little data directly relevant to patients with DCIS.

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.

Being tested
Surgery, Active Monitoring
Keywords
Ductal Carcinoma
Medical subject headings
Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryOther

    Surgery +/- radiation choice for endocrine therapy

  • Active MonitoringOther

    Choice for endocrine therapy

Study groups in NCT02926911
Study groupRoleWhat they receive
SurgeryActive comparatorDCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)
Receives: Other: Surgery
Active MonitoringExperimentalDCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Receives: Other: Active Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of New Diagnoses of Ipsilateral Invasive Cancer in Surgery and AM Arms at 2 Years of Follow up

    To compare the number of patients that develop ipsilateral invasive cancer that received surgery to the number of patients that were placed on active monitoring after 2 years of follow-up

    Measured: At 2 years follow-up

Secondary outcomes (13)

  1. Quality of Life (QOL)

    Measured by Short Form (SF)-36

    Measured: Baseline, 6 months, 1 year, and once a year (years 2 through 5)

  2. Psychological Outcomes

    Measured by five dimensions questionnaire (EQ-5D)

    Measured: Baseline, 6 months, 1 year, and once a year (years 2 through 5)

  3. Generalized Anxiety

    Measured by the State Trait Anxiety Inventory (STAI) scale

    Measured: Baseline, 6 months, 1 year, and once a year (years 2 through 5)

  4. Generalized Depression

    Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10

    Measured: Baseline, 6 months, 1 year, and once a year (years 2 through 5)

  5. Coping

    Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).

    Measured: Baseline

  6. Intolerance of Uncertainty

    Assessment of feelings of uncertainty using the Intolerance of Uncertainty Scale (Short-form), which has been used in studies of active monitoring in the prostate cancer setting.

    Measured: Baseline and at 2 years

  7. Mastectomy Rate

    To compare the impact of surgery vs. AM on the number of mastectomies performed in patients with DCIS

    Measured: 2, 5, and 7 year follow-up

  8. Breast Conservation Rate

    To compare the impact of surgery vs. AM on the number of breast conservation surgeries performed in patients with DCIS

    Measured: 2, 5, and 7 year follow-up

  9. Contralateral Invasive Cancer Rate

    To compare the impact of surgery vs. AM on the rate of development of contralateral invasive cancer in patients with DCIS

    Measured: 2, 5, and 7 year follow-up

  10. Overall Survival Rate

    To compare the impact of surgery vs. AM on the overall survival rate in patients with DCIS

    Measured: 2, 5, and 7 year follow-up

  11. Breast Cancer Specific Survival Rate

    To compare the impact of surgery vs. AM on the breast cancer specific survival rate in patients with DCIS

    Measured: 2, 5, and 7 year follow-up

  12. Ipsilateral Invasive Cancer Rate in Surgery Arm at 5 and 7 Year Follow-up

    To determine the number of DCIS patients in the surgery arm that develop ipsilateral invasive cancer

    Measured: 5 and 7 year follow-up

  13. Ipsilateral Invasive Cancer Rate in AM Arm

    To determine the number of DCIS patients in the AM arm that develop ipsilateral invasive cancer

    Measured: 5 and 7 year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2016 (estimated)
  2. Study start22 Feb 2017
  3. Primary completion27 Jun 2024
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
997 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02926911
Sponsor's protocol ID
AFT-25
Acronym
COMET
Status last verified
May 2026
First submitted
19 Sep 2016
Last updated
12 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Patient medical information both, associated with biologic specimens or not, is confidential and may only be disclosed to third parties as permitted by the Informed Consent Form (ICF) (or separate authorization for use and disclosure of personal health information) which has been signed by the patient, unless permitted or required by law. Data derived from biologic specimen analysis on individual patients will in generally not be provided to study investigators unless a request for research use is granted. The overall results of any research conducted using biologic specimens will be available in accordance with the effective Alliance Foundation Trial (AFT) policy on study data publication.

Publications

  • 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.

    PubMed 12381707

  • 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.

    PubMed 16319971

  • 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.

    PubMed 21390494

  • 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.

    PubMed 8096941

  • 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.

    PubMed 39665588

  • 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.

    PubMed 39665585

  • 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.

    PubMed 39289750

  • 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.

    PubMed 30862637

Questions about this trial

What is this clinical trial studying?

A study testing Surgery and Active Monitoring in people with DCIS and Ductal Carcinoma in Situ, run by Alliance Foundation Trials, LLC. at 141 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of New Diagnoses of Ipsilateral Invasive Cancer in Surgery and AM Arms at 2 Years of Follow up (time frame: At 2 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02926911, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in