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

• ClinicalTrials.gov Identifier: NCT02926911
• Recruitment Status: Recruiting
• First Posted: October 6, 2016
• Last Update Posted: February 21, 2023
• Sponsor: Alliance Foundation Trials, LLC.
• Collaborators: Patient-Centered Outcomes Research Institute; Duke University; Dana-Farber Cancer Institute; M.D. Anderson Cancer Center; New York University; Washington University School of Medicine
• Information provided by (Responsible Party): Alliance Foundation Trials, LLC.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
DCIS; Ductal Carcinoma in Situ	Other: Surgery; Other: Active Monitoring	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial
• Actual Study Start Date: February 22, 2017
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Surgery; DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)	Other: Surgery; Surgery +/- radiation choice for endocrine therapy
Experimental: Active Monitoring; DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)	Other: Active Monitoring; Choice for endocrine therapy

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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

Secondary Outcome Measures :

1. Quality of Life (QOL) [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   Measured by Short Form (SF)-36
2. Psychological outcomes [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   Measured by five dimensions questionnaire (EQ-5D)
3. Generalized anxiety [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   Measured by the State Trait Anxiety Inventory (STAI) scale
4. Generalized Depression [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10
5. Coping [ Time Frame: Baseline ]
   Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).
6. Intolerance of uncertainty [ Time Frame: Baseline and at 2 years ]
   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.
7. Mastectomy rate [ Time Frame: 2, 5, and 7 year follow-up ]
   To compare the impact of surgery vs. AM on the number of mastectomies performed in patients with DCIS
8. Breast conservation rate [ Time Frame: 2, 5, and 7 year follow-up ]
   To compare the impact of surgery vs. AM on the number of breast conservation surgeries performed in patients with DCIS
9. Contralateral invasive cancer rate [ Time Frame: 2, 5, and 7 year follow-up ]
   To compare the impact of surgery vs. AM on the rate of development of contralateral invasive cancer in patients with DCIS
10. Overall survival rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of surgery vs. AM on the overall survival rate in patients with DCIS
11. Breast cancer specific survival rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of surgery vs. AM on the breast cancer specific survival rate in patients with DCIS
12. Ipsilateral invasive cancer rate in surgery arm at 5 and 7 year follow-up [ Time Frame: 5 and 7 year follow-up ]
    To determine the number of DCIS patients in the surgery arm that develop ipsilateral invasive cancer
13. Ipsilateral invasive cancer rate in AM arm [ Time Frame: 5 and 7 year follow-up ]
    To determine the number of DCIS patients in the AM arm that develop ipsilateral invasive cancer

Other Outcome Measures:

1. Breast MRI utilization rate [ Time Frame: 2, 5, and 7 year follow-up ]
   Determine the rate of use of breast MRI imaging compared to use of other breast imaging techniques
2. Breast biopsy rate [ Time Frame: 2, 5, and 7 year follow-up ]
   Determine the rate of biopsies performed during follow-up of patients with DCIS
3. Radiation rate [ Time Frame: 2, 5, and 7 year follow-up ]
   Determine the rate of the performance of radiation therapy on patients with DCIS
4. Chemotherapy rate [ Time Frame: 2, 5, and 7 year follow-up ]
   Determine the rate of the use of chemotherapy on patients with DCIS
5. Self-reported co-morbidity [ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]
   Self-reported diary
6. Adherence to hormonal therapy [ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]
   Evaluated with a drug diary
7. Symptoms [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms
8. General pain [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference
9. Breast specific pain [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
   Breast specific pain will be measured by the Breast Cancer Pain Questionnaire (BCPQ); the BCPQ includes assessment of pain severity, pain frequency (how many days/week), and pain location (breast, arm, side, axilla), from which a Pain Burden Index (PBI) can be calculated
10. Body image [ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]
    Body image will be evaluated by the Breast-Questionnaire, a validated instrument to evaluate outcomes following surgery, will be used to evaluate satisfaction with body image
11. Decisional regret [ Time Frame: Years 1 through 5 ]
    The Decision Regret Scale will measure how women perceived their DCIS treatment decision. The SURE scale, which is composed of four items from the Decisional Conflict Scale will be used to measure patients' uncertainty about which treatment to choose and factors contributing to uncertainty (feeling uninformed, unclear values, and unsupported in decision-making).
12. Knowledge [ Time Frame: Baseline and 2 years ]
    DCIS and breast cancer knowledge will be measured with items adapted from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) as well as questions developed specifically for a study that assessed DCIS knowledge and risk perceptions. The investigators will assess risk perceptions in women with DCIS using questions developed by Lerman and Croyle that will measure risk perceptions in relation to psychosocial outcomes in women with DCIS
13. Risk perceptions [ Time Frame: Baseline and 2 years ]
    Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
14. Communication with physicians [ Time Frame: Baseline ]
    To assess communication with physicians about DCIS management options, the investigators will adapt items used in a prior study of surgical decision-making, including the extent to which their physician talked to them about AM vs. surgery. Additionally the investigators will ask about sources of information for the management of their DCIS
15. Financial burden [ Time Frame: 6 months ]
    The investigators will adapt items from the National Health Interview Survey and the Cancer Outcomes Research and Surveillance (CanCORS) Study to assess financial burden. The investigators will also ask women to Cancer Care estimate out of pocket expenses attributed to their DCIS diagnosis.
16. Employment status [ Time Frame: Baseline, 6 months, year 1, and once a year (years 1 through 5) ]
    Employment status will be assessed using a measure that is being added to the Alliance Patient Questionnaire as it has been tested and validated in breast cancer populations.
17. Concerns about future breast events [ Time Frame: Baseline and 2 years ]
    Four items from the Quality of Life in Adult Cancer Survivors (QLACS) scale will be adapted to evaluate frequency (1=never; 7=always) of worries about DCIS, including concerns about future breast events and death from DCIS

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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)

Contacts and Locations

Contacts

Contact: AFT Quality Management Group Inbox; 617-732-8727; clinicaltrials.queries@alliancefoundationtrials.org

Locations

United States, Alaska

Providence Alaska Medical Center; Recruiting

Anchorage, Alaska, United States, 99508

Contact: Jeanne Anderson, MD

United States, Arizona

Mayo Clinic; Recruiting

Phoenix, Arizona, United States, 85054

Contact: Patricia Cronin, MD

United States, California

City of Hope; Recruiting

Duarte, California, United States, 91010

Contact: Lisa D Yee

Cedars-Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Armando Giuliano, MD

Sharp Memorial Hospital; Recruiting

San Diego, California, United States, 92123

Contact: Reema Batra, MD

Kaiser Permanente Medical Center; Recruiting

Vallejo, California, United States, 94589

Contact: Samantha Seaward, MD

United States, Colorado

Colorado Cancer Research Program; Recruiting

Denver, Colorado, United States, 80222

Contact: Keren Sturtz, MD

Saint Joseph Hospital- Cancer Centers of Colorado; Recruiting

Lafayette, Colorado, United States, 80026

Contact: Benjamin George, MD

United States, Connecticut

Smilow Cancer Hospital at Yale-New Haven; Recruiting

New Haven, Connecticut, United States, 06510

Contact: Mehra Golshan, MD

United States, District of Columbia

MedStar Washington Hospital Center; Recruiting

Washington, District of Columbia, United States, 20010

Contact: Marc Boisvert, MD

United States, Florida

Memorial Healthcare System; Recruiting

Hollywood, Florida, United States, 33021

Contact: Sayeh Lavasani, MD

Mayo Clinic Florida; Recruiting

Jacksonville, Florida, United States, 32224

Contact: Sarah McLaughlin, MD

United States, Hawaii

University of Hawaii Cancer Center; Suspended

Honolulu, Hawaii, United States, 96813

United States, Idaho

Kootenai Health; Recruiting

Post Falls, Idaho, United States, 83854

Contact: Benjamin Marchello, MD

United States, Illinois

John H Stroger Jr Hospital of Cook County; Recruiting

Chicago, Illinois, United States, 60612

Contact: Thomas Lad, MD

University of Chicago Medical Center; Terminated

Chicago, Illinois, United States, 60637

Advocate Illinois Masonic Medical Center; Terminated

Chicago, Illinois, United States, 60657

NorthShore University HealthSystem-Evanston Hospital; Suspended

Evanston, Illinois, United States, 60201

Ingalls Memorial Hospital; Recruiting

Harvey, Illinois, United States, 60426

Contact: Danielle Sterrenberg, MD

Illinois Cancer Care; Recruiting

Peoria, Illinois, United States, 61615

Contact: Nguyet Le-Lindqwister, MD

OSF Saint Anthony Medical Center; Recruiting

Rockford, Illinois, United States, 61108

Contact: Shylendra Sreenivasappa, MD

Carle Cancer Center; Recruiting

Urbana, Illinois, United States, 61801

Contact: Anna Higham, MD

United States, Indiana

Indiana University Health Melvin and Bren Simon Cancer Center; Withdrawn

Indianapolis, Indiana, United States, 46202

United States, Iowa

Medical Oncology and Hematology Associates - Des Moines; Terminated

Des Moines, Iowa, United States, 50314

University of Iowa/Holden Comprehensive Cancer Center; Recruiting

Iowa City, Iowa, United States, 52242

Contact: Ingrid Lizarraga, MD

United States, Kansas

University of Kansas Cancer Center; Recruiting

Kansas City, Kansas, United States, 66160

Contact: Amanda Amin, MD

United States, Kentucky

St. Elizabeth Healthcare Edgewood; Recruiting

Edgewood, Kentucky, United States, 41017

Contact: J.Mike Guenther, MD

University of Kentucky/Markey Cancer Center; Recruiting

Lexington, Kentucky, United States, 40536

Contact: Emily Marcincowski, MD

United States, Louisiana

Mary Bird Perkins Cancer Center; Recruiting

Baton Rouge, Louisiana, United States, 70809

Contact: Mindy Bowie, MD

Ochsner Medical Center Jefferson; Recruiting

New Orleans, Louisiana, United States, 70121

Contact: Aimee Mackey, MD

United States, Maine

Eastern Maine Medical Center Cancer Care; Recruiting

Brewer, Maine, United States, 04412

Contact: Sarah Sinclair, DO

Maine Center for Cancer Medicine-Scarborough; Recruiting

Scarborough, Maine, United States, 04074

Contact: Chiara Battelli, MD

New England Cancer Specialists; Recruiting

Scarborough, Maine, United States, 04074

Contact: Chiara Battelli, MD

United States, Maryland

Anne Arundel Medical Center; Recruiting

Annapolis, Maryland, United States, 21401

Contact: Wen Liang, MD

University of Maryland - Greenebaum Comprehensive Cancer Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: Emily Bellavance, MD

United States, Massachusetts

Dana-Farber Cancer Institute; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Mehra Golshan, MD

United States, Michigan

Saint Joseph Mercy Hospital; Recruiting

Ann Arbor, Michigan, United States, 48197

Contact: Philip Stella, MD

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Contact: Jessica Bensenhaver, MD

Cancer Research Consortium of West Michigan; Recruiting

Grand Rapids, Michigan, United States, 49503

Contact: Kathleen Yost, MD

Beaumont NCORP; Terminated

Royal Oak, Michigan, United States, 48073

United States, Minnesota

Masonic Cancer Center, University of Minnesota; Suspended

Minneapolis, Minnesota, United States, 55455

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Sandhya Pruthi, MD

Metro MN Community Oncology Research Consortium (MMCORC); Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contact: Michaela Tsai, MD

United States, Missouri

Washington University - Siteman Cancer Center; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Rebecca Aft, MD

United States, Montana

Community Hospital of Anaconda; Recruiting

Anaconda, Montana, United States, 59711

Contact: Benjamin Marchello, MD

Billings Clinic; Recruiting

Billings, Montana, United States, 59101

Contact: Benjamin Marchello, MD

Bozeman Health; Recruiting

Bozeman, Montana, United States, 59715

Contact: Benjamin Marchello, MD

Benefis Sletten Cancer Institute; Recruiting

Great Falls, Montana, United States, 59405

Contact: Benjamin Marchello, MD

Kalispell Regional Medical Center; Recruiting

Kalispell, Montana, United States, 59901

Contact: Benjamin Marchello, MD

Community Medical Center; Recruiting

Missoula, Montana, United States, 59804

Contact: Benjamin Marchello, MD

United States, Nebraska

University of Nebraska Medical Center; Recruiting

Omaha, Nebraska, United States, 68198

Contact: Jessica Maxwell, MD

United States, Nevada

Carson Tahoe Health; Withdrawn

Carson City, Nevada, United States, 89703

United States, New Hampshire

New Hampshire Oncology Hematology PA; Recruiting

Hooksett, New Hampshire, United States, 03106

Contact: Douglas Weckstein, MD

United States, New Jersey

Englewood Hospital and Medical Center; Recruiting

Englewood, New Jersey, United States, 07631

Contact: Violet M McIntosh, MD

Hackensack University Medical Center; Recruiting

Hackensack, New Jersey, United States, 07601

Contact: Tara Balija, MD

Atlantic Health System / Morristown Medical Center; Recruiting

Morristown, New Jersey, United States, 07960

Contact: Faith Goldman, MD

Jersey Shore University Medical Center; Recruiting

Neptune, New Jersey, United States, 07753

Contact: Denise Miller, MD

The Valley Hospital - Luckow Pavilion; Recruiting

Paramus, New Jersey, United States, 07652

Contact: Moira Christoudias, MD

United States, New Mexico

New Mexico Cancer Care Alliance; Recruiting

Albuquerque, New Mexico, United States, 87106

Contact: Sangeetha Prabhakaran, MD

United States, New York

Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park; Suspended

Bronx, New York, United States, 10461

Roswell Park Cancer Institute; Recruiting

Buffalo, New York, United States, 14263

Contact: Ellis Levine, MD

New York-Presbyterian Weill Cornell Medical Center; Recruiting

New York, New York, United States, 10065

Contact: Eleni Andreopoulou, MD

Mount Sinai Hospital; Recruiting

New York, New York, United States, 60608

Contact: Hank Schmidt, MD

Stony Brook Medical Center; Withdrawn

Stony Brook, New York, United States, 11794

State University of New York Upstate Medical University; Recruiting

Syracuse, New York, United States, 13210

Contact: Lisa Lai, MD

United States, North Carolina

UNC Lineberger Comprehensive Cancer Center; Recruiting

Chapel Hill, North Carolina, United States, 27599

Contact: Kristalyn Gallagher, DO

Levine Cancer Institute; Recruiting

Charlotte, North Carolina, United States, 28204

Contact: Deba Sarma, MD

Novant Health Presbyterian Medical Center; Recruiting

Charlotte, North Carolina, United States, 28204

Contact: Nasfat Shehadeh, MD

Duke University Medical Center; Recruiting

Durham, North Carolina, United States, 27710

Contact: Oluwadamilola Fayanju, MD

Cape Fear Valley Health System; Recruiting

Fayetteville, North Carolina, United States, 28304

Contact: Kenneth Manning, MD

Southeastern Medical Oncology Center; Terminated

Goldsboro, North Carolina, United States, 27534

Cone Health Cancer Center; Recruiting

Greensboro, North Carolina, United States, 27403

Contact: Vinay Gudena, MD

Novant Health Breast Surgery - Greensboro; Recruiting

Greensboro, North Carolina, United States, 27403

Contact: Judy A Tjoe, MD

East Carolina University; Recruiting

Greenville, North Carolina, United States, 27834

Contact: Jan Wong, MD

Carolina East Medical Center; Terminated

New Bern, North Carolina, United States, 28561

Rex Cancer Center; Recruiting

Raleigh, North Carolina, United States, 27607

Contact: Henry Cromartie, MD

Wake Forest Baptist Medical Center; Recruiting

Winston-Salem, North Carolina, United States, 27157

Contact: Akiko Chiba, MD

United States, Ohio

Strecker Cancer Center - Belpre; Recruiting

Belpre, Ohio, United States, 45714

Contact: Thomas Moore, MD

Dayton Physicians-Miami Valley Hospital South; Recruiting

Centerville, Ohio, United States, 45459

Contact: Howard Gross, MD

Ohio State University Comprehensive Cancer Center; Recruiting

Columbus, Ohio, United States, 43202

Contact: Doreen Agnese, MD

Ohio State University Comprehensive Cancer Center; Recruiting

Columbus, Ohio, United States, 43210

Contact: Doreen Agnese, MD

Mount Carmel East Hospital; Recruiting

Columbus, Ohio, United States, 43213

Contact: Thomas Moore, MD

Columbus Oncology & Hematology INC; Recruiting

Columbus, Ohio, United States, 43214

Contact: Thomas Moore, MD

Riverside Methodist Hospital; Recruiting

Columbus, Ohio, United States, 43214

Contact: Thomas Moore, MD

Grant Medical Center; Recruiting

Columbus, Ohio, United States, 43215

Contact: Thomas Moore, MD

MidOhio Oncology Hematology, Mark H. Zangmeister Center; Recruiting

Columbus, Ohio, United States, 43219

Contact: Thomas Moore, MD

Mount Carmel West Hospital; Recruiting

Columbus, Ohio, United States, 43223

Contact: Thomas Moore, MD

Doctors Hospital; Recruiting

Columbus, Ohio, United States, 43228

Contact: Thomas Moore, MD

Dayton Physicians-Miami Valley Hospital North; Recruiting

Dayton, Ohio, United States, 45415

Contact: Howard Gross, MD

Grady Hospital; Recruiting

Delaware, Ohio, United States, 43015

Contact: Thomas Moore, MD

OhioHealth Grady - Delaware Health Center; Recruiting

Delaware, Ohio, United States, 43015

Contact: Thomas Moore, MD

Armes Family Cancer Center; Recruiting

Findlay, Ohio, United States, 45840

Contact: Howard Gross, MD

Dayton Physicians-Atrium; Recruiting

Franklin, Ohio, United States, 45005

Contact: Howard Gross, MD

Wayne Hospital; Recruiting

Greenville, Ohio, United States, 45331

Contact: Howard Gross, MD

Kettering Medical Center; Recruiting

Kettering, Ohio, United States, 45429

Contact: Howard Gross, MD

OhioHealth Mansfield Hospital; Recruiting

Mansfield, Ohio, United States, 44903

Contact: Thomas Moore, MD

Marietta Memorial Hospital; Recruiting

Marietta, Ohio, United States, 45750

Contact: Thomas Moore, MD

OhioHealth Marion General Hospital; Recruiting

Marion, Ohio, United States, 43302

Contact: Thomas Moore, MD

Licking Memorial Hospital; Recruiting

Newark, Ohio, United States, 43055

Contact: Thomas Moore, MD

St. Ann's Hospital; Recruiting

Westerville, Ohio, United States, 43081

Contact: Thomas Moore, MD

St. Elizabeth Youngstown Hospital; Recruiting

Youngstown, Ohio, United States, 44501

Contact: Howard Gross, MD

Genesis Health Care System; Recruiting

Zanesville, Ohio, United States, 43701

Contact: Thomas Moore, MD

United States, Oklahoma

Cancer Centers of Southwest Oklahoma; Recruiting

Lawton, Oklahoma, United States, 73505

Contact: Jose Najera, MD

United States, Oregon

Saint Charles Health System; Suspended

Bend, Oregon, United States, 97701

United States, Pennsylvania

Magee-Womens Hospital of UPMC; Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contact: Priscilla McAuliffe, MD

Guthrie Medical Group PC-Robert Packer Hospital; Recruiting

Sayre, Pennsylvania, United States, 18840

Contact: M. Firdos Ziauddin, MD

WellSpan Health York Cancer Center; Suspended

York, Pennsylvania, United States, 17403

United States, Rhode Island

Rhode Island Hospital; Terminated

Providence, Rhode Island, United States, 02906

United States, South Carolina

Medical University of South Carolina; Terminated

Charleston, South Carolina, United States, 29425

Georgetown Hospital System; Recruiting

Georgetown, South Carolina, United States, 29440

Contact: Angela Mislowsky, MD

Greenville Memorial Hospital; Recruiting

Greenville, South Carolina, United States, 29605

Contact: Jeffrey Giguere, MD

United States, Tennessee

Baptist Cancer Care; Suspended

Memphis, Tennessee, United States, 38120

United States, Texas

UT Southwestern/Simmons Cancer Center-Dallas; Recruiting

Dallas, Texas, United States, 75235

Contact: Marilyn Leitch, MD

Baylor University Medical Center; Recruiting

Dallas, Texas, United States, 75246

Contact: Tuoc Dao, MD

MD Anderson Cancer Center; Suspended

Houston, Texas, United States, 60586

Doctors Hospital of Laredo; Recruiting

Laredo, Texas, United States, 78045

Contact: Gary Unzeitig, MD

United States, Utah

Huntsman Cancer Institute; Recruiting

Salt Lake City, Utah, United States, 84112

Contact: Cindy Matsen, MD

United States, Vermont

The University of Vermont Medical Center; Recruiting

Burlington, Vermont, United States, 05401

Contact: Jessica Cintolo-Gonzalez, MD

United States, Virginia

West Virginia University Medicine; Recruiting

Morgantown, Virginia, United States, 26506

Contact: Geraldine Jacobson, MD

Sentara Norfolk General Hospital; Recruiting

Norfolk, Virginia, United States, 23507

Contact: Eric C. Feliberti, MD

Virginia Commonwealth University Massey Cancer Center; Suspended

Richmond, Virginia, United States, 23298

United States, Washington

Overlake Hospital Medical Center; Suspended

Bellevue, Washington, United States, 98004

United States, Wisconsin

ThedaCare Regional Cancer Center -Appleton; Recruiting

Appleton, Wisconsin, United States, 54911

Contact: Natasha Edwin, MD

Aurora Health Care, Aurora Cancer Care; Suspended

Burlington, Wisconsin, United States, 53105

Aurora Health Center - Fond du Lac; Suspended

Fond Du Lac, Wisconsin, United States, 54937

Aurora Health Care, Germantown Health Center; Suspended

Germantown, Wisconsin, United States, 53022

Aurora Health Care, Aurora Cancer Care; Suspended

Grafton, Wisconsin, United States, 53024

Saint Vincent Hospital; Suspended

Green Bay, Wisconsin, United States, 54301

BayCare Aurora LLC, Aurora Cancer Care; Recruiting

Green Bay, Wisconsin, United States, 54311

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Kenosha, Wisconsin, United States, 49408

Contact: Meredith Witten, MD

University of Wisconsin Carbone Cancer Center; Recruiting

Madison, Wisconsin, United States, 53792

Contact: Heather Neuman, MD

Aurora Bay Area Medical Group - Cancer Care Clinic; Recruiting

Marinette, Wisconsin, United States, 54143

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Marinette, Wisconsin, United States, 54143

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Milwaukee, Wisconsin, United States, 53209

Contact: Meredith Witten, MD

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

Milwaukee, Wisconsin, United States, 53215

Contact: Judy Tjoe, MD

Froedtert and the Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Tina Yen, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Milwaukee, Wisconsin, United States, 53233

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Oshkosh, Wisconsin, United States, 54904

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Racine, Wisconsin, United States, 53406

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Sheboygan, Wisconsin, United States, 53081

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Summit, Wisconsin, United States, 53066

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Two Rivers, Wisconsin, United States, 54241

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contact: Meredith Witten, MD

Aurora Health Care, Aurora Cancer Care; Recruiting

West Allis, Wisconsin, United States, 53227

Contact: Meredith Witten, MD

Sponsors and Collaborators

Alliance Foundation Trials, LLC.

Patient-Centered Outcomes Research Institute

Duke University

Dana-Farber Cancer Institute

M.D. Anderson Cancer Center

New York University

Washington University School of Medicine

Investigators

• Principal Investigator: Shelley Hwang, MD, MPH; Duke University
• Study Chair: Ann Partridge, MD, MPH; Dana-Farber Cancer Institute
• Study Chair: Alastair Thompson, MD; Baylor College of Medicine

More Information

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.

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. Erratum In: Lancet 1993 Nov 27;342(8883):1372.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Alliance Foundation Trials, LLC.
• ClinicalTrials.gov Identifier: NCT02926911
• Other Study ID Numbers: AFT-25
• First Posted: October 6, 2016
• Last Update Posted: February 21, 2023
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Time Frame: Data will become available July 2023, no end date.
• Access Criteria: following a formal request by an investigator to and approval from AFT

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alliance Foundation Trials, LLC.:

Ductal Carcinoma

Additional relevant MeSH terms:

Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ