Could monitoring replace surgery for some breast lesions?

NCT ID NCT02926911

Disease control Sponsor: Alliance Foundation Trials, LLC. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares active monitoring (regular checkups without immediate treatment) to surgery for people with low-risk ductal carcinoma in situ (DCIS), a very early form of breast cancer. About 1,000 participants are being followed for two years to see if monitoring is as good as surgery at preventing invasive cancer and maintaining quality of life. The goal is to find out if some patients can safely avoid surgery.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

997 people

The number who actually took part.

Started

Feb 2017

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Carcinoma, Ductal ductal breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DCIS Ductal carcinoma in situ

Contacts and locations

Locations

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States
Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States
Armes Family Cancer Center

Findlay, Ohio, 45840, United States
Atlantic Health System / Morristown Medical Center

Morristown, New Jersey, 07960, United States
Aurora Bay Area Medical Group - Cancer Care Clinic

Marinette, Wisconsin, 54143, United States
Aurora Health Care, Aurora Cancer Care

Burlington, Wisconsin, 53105, United States
Aurora Health Care, Aurora Cancer Care

Grafton, Wisconsin, 53024, United States
Aurora Health Care, Aurora Cancer Care

Kenosha, Wisconsin, 49408, United States
Aurora Health Care, Aurora Cancer Care

Marinette, Wisconsin, 54143, United States
Aurora Health Care, Aurora Cancer Care

Milwaukee, Wisconsin, 53209, United States
Aurora Health Care, Aurora Cancer Care

Milwaukee, Wisconsin, 53233, United States
Aurora Health Care, Aurora Cancer Care

Oshkosh, Wisconsin, 54904, United States
Aurora Health Care, Aurora Cancer Care

Racine, Wisconsin, 53406, United States
Aurora Health Care, Aurora Cancer Care

Sheboygan, Wisconsin, 53081, United States
Aurora Health Care, Aurora Cancer Care

Summit, Wisconsin, 53066, United States
Aurora Health Care, Aurora Cancer Care

Two Rivers, Wisconsin, 54241, United States
Aurora Health Care, Aurora Cancer Care

Wauwatosa, Wisconsin, 53226, United States
Aurora Health Care, Aurora Cancer Care

West Allis, Wisconsin, 53227, United States
Aurora Health Care, Germantown Health Center

Germantown, Wisconsin, 53022, United States
Aurora Health Center - Fond du Lac

Fond du Lac, Wisconsin, 54937, United States
Baptist Cancer Care

Memphis, Tennessee, 38120, United States
BayCare Aurora LLC, Aurora Cancer Care

Green Bay, Wisconsin, 54311, United States
Baylor University Medical Center

Dallas, Texas, 75246, United States
Beaumont NCORP

Royal Oak, Michigan, 48073, United States
Benefis Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Billings Clinic

Billings, Montana, 59101, United States
Bozeman Health

Bozeman, Montana, 59715, United States
Cancer Centers of Southwest Oklahoma

Lawton, Oklahoma, 73505, United States
Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, 49503, United States
Cape Fear Valley Health System

Fayetteville, North Carolina, 28304, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carolina East Medical Center

New Bern, North Carolina, 28561, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
City of Hope

Duarte, California, 91010, United States
Colorado Cancer Research Program

Denver, Colorado, 80222, United States
Columbus Oncology & Hematology INC

Columbus, Ohio, 43214, United States
Community Hospital of Anaconda

Anaconda, Montana, 59711, United States
Community Medical Center

Missoula, Montana, 59804, United States
Cone Health Cancer Center

Greensboro, North Carolina, 27403, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dayton Physicians-Atrium

Franklin, Ohio, 45005, United States
Dayton Physicians-Miami Valley Hospital North

Dayton, Ohio, 45415, United States
Dayton Physicians-Miami Valley Hospital South

Centerville, Ohio, 45459, United States
Doctors Hospital

Columbus, Ohio, 43228, United States
Doctors Hospital of Laredo

Laredo, Texas, 78045, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
East Carolina University

Greenville, North Carolina, 27834, United States
Eastern Maine Medical Center Cancer Care

Brewer, Maine, 04412, United States
Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States
Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Genesis Health Care System

Zanesville, Ohio, 43701, United States
Georgetown Hospital System

Georgetown, South Carolina, 29440, United States
Grady Hospital

Delaware, Ohio, 43015, United States
Grant Medical Center

Columbus, Ohio, 43215, United States
Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States
Guthrie Medical Group PC-Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States
Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States
Henry Ford Hospital

Detroit, Michigan, 48202, United States
Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States
Illinois Cancer Care

Peoria, Illinois, 61615, United States
Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States
Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States
John H Stroger Jr Hospital of Cook County

Chicago, Illinois, 60612, United States
Kaiser Permanente Medical Center

Vallejo, California, 94589, United States
Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States
Kettering Medical Center

Kettering, Ohio, 45429, United States
Kootenai Health

Post Falls, Idaho, 83854, United States
Levine Cancer Institute

Charlotte, North Carolina, 28204, United States
Licking Memorial Hospital

Newark, Ohio, 43055, United States
MD Anderson Cancer Center

Houston, Texas, 60586, United States
Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States
Maine Center for Cancer Medicine-Scarborough

Scarborough, Maine, 04074, United States
Marietta Memorial Hospital

Marietta, Ohio, 45750, United States
Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809, United States
Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, 55455, United States
Mayo Clinic

Phoenix, Arizona, 85054, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Mayo Clinic Florida

Jacksonville, Florida, 32224, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical Oncology and Hematology Associates - Des Moines

Des Moines, Iowa, 50314, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Healthcare System

Hollywood, Florida, 33021, United States
Metro MN Community Oncology Research Consortium (MMCORC)

Saint Louis Park, Minnesota, 55416, United States
MidOhio Oncology Hematology, Mark H. Zangmeister Center

Columbus, Ohio, 43219, United States
Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park

The Bronx, New York, 10461, United States
Mount Carmel East Hospital

Columbus, Ohio, 43213, United States
Mount Carmel West Hospital

Columbus, Ohio, 43223, United States
Mount Sinai Hospital

New York, New York, 60608, United States
New England Cancer Specialists

Scarborough, Maine, 04074, United States
New Hampshire Oncology Hematology PA

Hooksett, New Hampshire, 03106, United States
New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87106, United States
New York-Presbyterian Weill Cornell Medical Center

New York, New York, 10065, United States
NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States
Novant Health Breast Surgery - Greensboro

Greensboro, North Carolina, 27403, United States
Novant Health Presbyterian Medical Center

Charlotte, North Carolina, 28204, United States
OSF Saint Anthony Medical Center

Rockford, Illinois, 61108, United States
Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43202, United States
Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States
OhioHealth Grady - Delaware Health Center

Delaware, Ohio, 43015, United States
OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903, United States
OhioHealth Marion General Hospital

Marion, Ohio, 43302, United States
Overlake Hospital Medical Center

Bellevue, Washington, 98004, United States
Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States
Rex Cancer Center

Raleigh, North Carolina, 27607, United States
Rhode Island Hospital

Providence, Rhode Island, 02906, United States
Riverside Methodist Hospital

Columbus, Ohio, 43214, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Saint Charles Health System

Bend, Oregon, 97701, United States
Saint Joseph Hospital- Cancer Centers of Colorado

Lafayette, Colorado, 80026, United States
Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48197, United States
Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States
Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States
Sharp Memorial Hospital

San Diego, California, 92123, United States
Smilow Cancer Hospital at Yale-New Haven

New Haven, Connecticut, 06510, United States
Southeastern Medical Oncology Center

Goldsboro, North Carolina, 27534, United States
St. Ann's Hospital

Westerville, Ohio, 43081, United States
St. Elizabeth Healthcare Edgewood

Edgewood, Kentucky, 41017, United States
St. Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Strecker Cancer Center - Belpre

Belpre, Ohio, 45714, United States
The University of Vermont Medical Center

Burlington, Vermont, 05401, United States
The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652, United States
ThedaCare Regional Cancer Center -Appleton

Appleton, Wisconsin, 54911, United States
UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75235, United States
University of Chicago Medical Center

Chicago, Illinois, 60637, United States
University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States
University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States
University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Maryland - Greenebaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States
University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States
University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States
Vince Lombardi Cancer Clinic of Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States
Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States
Washington University - Siteman Cancer Center

St Louis, Missouri, 63110, United States
Wayne Hospital

Greenville, Ohio, 45331, United States
WellSpan Health York Cancer Center

York, Pennsylvania, 17403, United States
West Virginia University Medicine

Morgantown, Virginia, 26506, United States

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