Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:40 - 99
Updated:2/13/2019
Start Date:February 22, 2017
End Date:July 2023
Contact:Thomas Lynch, PhD
Email:thomas.lynch2@duke.edu
Phone:(443) 286-4595

Use our guide to learn which trials are right for you!

Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

This study looks at the risks and benefits of active surveillance (AS) compared to guideline
concordant care (GCC) 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 AS approach does not yield inferior cancer or quality of life outcomes
compared to GCC.

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
surveillance (AS) approach does not yield inferior cancer or quality of life outcomes
compared to guideline concordant care (GCC).

Inclusion Criteria:

- New diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date
of the first pathology report that diagnosed the patient with DCIS

- Unilateral, bilateral, unifocal, or multifocal DCIS

- ADH/borderline DCIS

- A patient who has had a lumpectomy with positive margins as part of their treatment
for a current DCIS diagnosis is eligible (post-excision mammogram required at
enrollment to establish a new baseline)

- No previous history of breast cancer (DCIS or invasive cancer) in either breast 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:

- 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)

- Pathologic criteria:

- Any grade I DCIS (irrespective of necrosis/comedonecrosis)

- Any grade II DCIS (irrespective of necrosis/comedonecrosis)

- Absence of invasion or microinvasion

- Diagnosis confirmed on core needle, vacuum-assisted or surgery ≤ 120 days of
registration

- ER(+) and/or PR(+) by IHC (≥ 10% staining or Allred score ≥ 4)

- 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 mammographic extent of
calcifications exceeds 4 cm, with second biopsy benign or both sites fulfilling
pathology eligibility criteria

- 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 imaging at site of DCIS prior to biopsy yielding
diagnosis of DCIS, with exception of fibroadenoma at a distinct/separate site from
site of DCIS (or diagnosis of mass as a cyst). 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

- Bloody nipple discharge (ipsilateral breast)

- Mammographic finding of BIRADS 4 or greater within 6 months of registration at site
other than that of known DCIS, without pathologic assessment

- Use of investigational cancer agents within 6 weeks prior to diagnosis

- 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; however, a pregnancy test for all women of
child-bearing potential is not mandatory

- Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene in last 6
months
We found this trial at
117
sites
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Armando Giuliano, MD
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Anaconda, Montana 59711
?
mi
from
Anaconda, MT
Click here to add this to my saved trials
Anchorage, Alaska 99508
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Annapolis, Maryland 21401
Principal Investigator: Wen Liang, MD
Phone: 443-481-5749
?
mi
from
Annapolis, MD
Click here to add this to my saved trials
22 South Greene Street
Baltimore, Maryland 21201
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Washington 98004
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
?
mi
from
Belpre, OH
Click here to add this to my saved trials
Bend, Oregon 97701
?
mi
from
Bend, OR
Click here to add this to my saved trials
801 North 29th Street
Billings, Montana 59107
406-238-2500
Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
?
mi
from
Billings, MT
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Mehra Golshan, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials
915 Highland Boulevard
Bozeman, Montana 59715
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
?
mi
from
Brewer, ME
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Burlington, Vermont 05405
?
mi
from
Burlington, VT
Click here to add this to my saved trials
248 McHenry Street
Burlington, Wisconsin 53105
?
mi
from
Burlington, WI
Click here to add this to my saved trials
1600 Medical Parkway
Carson City, Nevada 89703
Principal Investigator: Dina Tack, MD
?
mi
from
Carson City, NV
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43213
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43214
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3100 Plaza Properties Boulevard
Columbus, Ohio 43219
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Columbus, Ohio 43222
?
mi
from
Columbus, OH
Click here to add this to my saved trials
3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
561 West Central Avenue
Delaware, Ohio 43015
?
mi
from
Delaware, OH
Click here to add this to my saved trials
561 West Central Avenue
Delaware, Ohio 43015
?
mi
from
Delaware, OH
Click here to add this to my saved trials
Denver, Colorado 80224
Principal Investigator: Keren Sturtz, MD
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Oluwadamilola Fayanju, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
?
mi
from
Durham, NC
Click here to add this to my saved trials
Edgewood, Kentucky 41017
Principal Investigator: J.Mike Guenther, MD
?
mi
from
Edgewood, KY
Click here to add this to my saved trials
350 Engle St
Englewood, New Jersey 07631
(201) 894-3000
Englewood Hospital and Medical Center Englewood Hospital was incorporated in 1888 as a non-profit, non-sectarian...
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
?
mi
from
Evanston, IL
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
?
mi
from
Fayetteville, NC
Click here to add this to my saved trials
Fond Du Lac, Wisconsin 54937
?
mi
from
Fond Du Lac, WI
Click here to add this to my saved trials
Georgetown, South Carolina 29440
?
mi
from
Georgetown, SC
Click here to add this to my saved trials
Germantown, Wisconsin 53022
?
mi
from
Germantown, WI
Click here to add this to my saved trials
Goldsboro, North Carolina 27534
Principal Investigator: James Atkins, MD
?
mi
from
Goldsboro, NC
Click here to add this to my saved trials
215 West Washington Street
Grafton, Wisconsin 53024
?
mi
from
Grafton, WI
Click here to add this to my saved trials
Grand Rapids, Michigan 49503
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Great Falls, Montana 59405
?
mi
from
Great Falls, MT
Click here to add this to my saved trials
2845 Greenbrier Road
Green Bay, Wisconsin 54311
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
?
mi
from
Green Bay, WI
Click here to add this to my saved trials
501 N. Elam Avenue
Greensboro, North Carolina 27403
336-832-1100
Principal Investigator: Vinay Gudena, MD
Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Jan Wong, MD
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
?
mi
from
Greenville, NC
Click here to add this to my saved trials
701 Grove Rd
Greenville, South Carolina 29605
(864) 455-7000
Greenville Memorial Hospital Greenville Memorial Medical Campus is a regional referral center for the diagnosis...
?
mi
from
Greenville, SC
Click here to add this to my saved trials
30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
?
mi
from
Harvey, IL
Click here to add this to my saved trials
Hollywood, Florida
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Honolulu, Hawaii 96813
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Hooksett, New Hampshire 03106
Principal Investigator: Douglas Weckstein, MD
Phone: 603-232-8988
?
mi
from
Hooksett, NH
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Principal Investigator: Samillia Obeng-Gyasi, MD
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
Click here to add this to my saved trials
Kenosha, Wisconsin 49408
?
mi
from
Kenosha, WI
Click here to add this to my saved trials
Laredo, Texas 78041
?
mi
from
Laredo, TX
Click here to add this to my saved trials
Lawton, Oklahoma 73505
Principal Investigator: Jose Najera, MD
Phone: 580-536-2121
?
mi
from
Lawton, OK
Click here to add this to my saved trials
600 Highland Ave.
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
?
mi
from
Madison, WI
Click here to add this to my saved trials
Mansfield, Ohio 44903
?
mi
from
Mansfield, OH
Click here to add this to my saved trials
401 Matthew St
Marietta, Ohio 45750
(740) 374-1455
Marietta Memorial Hospital We are 2,600 strong and the county
?
mi
from
Marietta, OH
Click here to add this to my saved trials
3100 Shore Drive
Marinette, Wisconsin 54143
?
mi
from
Marinette, WI
Click here to add this to my saved trials
4061 Old Peshtigo Road
Marinette, Wisconsin 54143
?
mi
from
Marinette, WI
Click here to add this to my saved trials
?
mi
from
Marion, OH
Click here to add this to my saved trials
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: Tina Yen, MD
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Missoula, Montana 59801
?
mi
from
Missoula, MT
Click here to add this to my saved trials
New Bern, North Carolina 28560
?
mi
from
New Bern, NC
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
1320 W Main St
Newark, Ohio 43055
(740) 348-4000
Licking Memorial Hospital Licking Memorial Health Systems (LMHS) is a not-for-profit health care organization dedicated...
?
mi
from
Newark, OH
Click here to add this to my saved trials
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
855 North Westhaven Drive
Oshkosh, Wisconsin 54904
?
mi
from
Oshkosh, WI
Click here to add this to my saved trials
Paramus, New Jersey 07652
?
mi
from
Paramus, NJ
Click here to add this to my saved trials
Peoria, Illinois 61656
?
mi
from
Peoria, IL
Click here to add this to my saved trials
300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Priscilla McAuliffe, MD
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Post Falls, Idaho 83854
?
mi
from
Post Falls, ID
Click here to add this to my saved trials
8400 Washington Avenue
Racine, Wisconsin 53406
?
mi
from
Racine, WI
Click here to add this to my saved trials
Raleigh, North Carolina 27609
Principal Investigator: Henry Cromartie, MD
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
5510 East State Street
Rockford, Illinois 61108
?
mi
from
Rockford, IL
Click here to add this to my saved trials
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
Click here to add this to my saved trials
4960 Childrens Place
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
3800 Park Nicollet Boulevard
Saint Louis Park, Minnesota 55416
Principal Investigator: Michaela Tsai, MD
?
mi
from
Saint Louis Park, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84112
Principal Investigator: Cindy Matsen, MD
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
?
mi
from
San Diego, CA
Click here to add this to my saved trials