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ACTIVE NOT RECRUITING

NCT02926911

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

Sponsor: Alliance Foundation Trials, LLC.

View on ClinicalTrials.gov

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 of life outcomes compared to surgery.

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

Key Details

Gender

FEMALE

Age Range

40 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

997

Start Date

2017-02-22

Completion Date

2030-07

Last Updated

2026-01-27

Healthy Volunteers

Conditions

DCIS Ductal Carcinoma in Situ

Interventions

OTHER

Surgery

Surgery +/- radiation choice for endocrine therapy

OTHER

Active Monitoring

Choice for endocrine therapy

Inclusion Criteria: * 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 * 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: * 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 * 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)

Locations (141)

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