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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ductal Carcinoma in Situ; DCIS
• Intervention / Treatment: Other: Surgery; Other: Active Monitoring

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 Type: Interventional
• Enrollment (Actual): 997
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AFT Quality Management Group Inbox; Phone Number: 617-732-8727; Email: clinicaltrials.queries@alliancefoundationtrials.org

Study Locations

• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Providence Alaska Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Center
  • Colorado
    • Denver, Colorado, United States, 80222
      • Colorado Cancer Research Program
    • Lafayette, Colorado, United States, 80026
      • Saint Joseph Hospital- Cancer Centers of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale-New Haven
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
  • Idaho
    • Post Falls, Idaho, United States, 83854
      • Kootenai Health
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr Hospital of Cook County
    • Chicago, Illinois, United States, 60657
      • Advocate Illinois Masonic Medical Center
    • Evanston, Illinois, United States, 60201
      • NorthShore University HealthSystem-Evanston Hospital
    • Harvey, Illinois, United States, 60426
      • Ingalls Memorial Hospital
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Rockford, Illinois, United States, 61108
      • OSF Saint Anthony Medical Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Medical Oncology and Hematology Associates - Des Moines
    • Iowa City, Iowa, United States, 52242
      • University of Iowa/Holden Comprehensive Cancer Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare Edgewood
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky/Markey Cancer Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Mary Bird Perkins Cancer Center
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center Jefferson
  • Maine
    • Brewer, Maine, United States, 04412
      • Eastern Maine Medical Center Cancer Care
    • Scarborough, Maine, United States, 04074
      • New England Cancer Specialists
    • Scarborough, Maine, United States, 04074
      • Maine Center for Cancer Medicine-Scarborough
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21201
      • University of Maryland - Greenebaum Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Ann Arbor, Michigan, United States, 48197
      • Saint Joseph Mercy Hospital
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49503
      • Cancer Research Consortium of West Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont NCORP
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center, University of Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro MN Community Oncology Research Consortium (MMCORC)
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University - Siteman Cancer Center
  • Montana
    • Anaconda, Montana, United States, 59711
      • Community Hospital of Anaconda
    • Billings, Montana, United States, 59101
      • Billings Clinic
    • Bozeman, Montana, United States, 59715
      • Bozeman Health
    • Great Falls, Montana, United States, 59405
      • Benefis Sletten Cancer Institute
    • Kalispell, Montana, United States, 59901
      • Kalispell Regional Medical Center
    • Missoula, Montana, United States, 59804
      • Community Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Hampshire
    • Hooksett, New Hampshire, United States, 03106
      • New Hampshire Oncology Hematology PA
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Hospital and Medical Center
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System / Morristown Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital - Luckow Pavilion
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Cancer Care Alliance
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • New York-Presbyterian Weill Cornell Medical Center
    • New York, New York, United States, 60608
      • Mount Sinai Hospital
    • Syracuse, New York, United States, 13210
      • State University of New York Upstate Medical University
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Lineberger Comprehensive Cancer Center
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Fayetteville, North Carolina, United States, 28304
      • Cape Fear Valley Health System
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
    • Greensboro, North Carolina, United States, 27403
      • Novant Health Breast Surgery - Greensboro
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
    • New Bern, North Carolina, United States, 28561
      • Carolina East Medical Center
    • Raleigh, North Carolina, United States, 27607
      • Rex Cancer Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Belpre, Ohio, United States, 45714
      • Strecker Cancer Center - Belpre
    • Centerville, Ohio, United States, 45459
      • Dayton Physicians-Miami Valley Hospital South
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43228
      • Doctors Hospital
    • Columbus, Ohio, United States, 43213
      • Mount Carmel East Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Columbus, Ohio, United States, 43202
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43214
      • Columbus Oncology & Hematology INC
    • Columbus, Ohio, United States, 43219
      • MidOhio Oncology Hematology, Mark H. Zangmeister Center
    • Columbus, Ohio, United States, 43223
      • Mount Carmel West Hospital
    • Dayton, Ohio, United States, 45415
      • Dayton Physicians-Miami Valley Hospital North
    • Delaware, Ohio, United States, 43015
      • Grady Hospital
    • Delaware, Ohio, United States, 43015
      • OhioHealth Grady - Delaware Health Center
    • Findlay, Ohio, United States, 45840
      • Armes Family Cancer Center
    • Franklin, Ohio, United States, 45005
      • Dayton Physicians-Atrium
    • Greenville, Ohio, United States, 45331
      • Wayne Hospital
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Mansfield, Ohio, United States, 44903
      • OhioHealth Mansfield Hospital
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital
    • Marion, Ohio, United States, 43302
      • OhioHealth Marion General Hospital
    • Newark, Ohio, United States, 43055
      • Licking Memorial Hospital
    • Westerville, Ohio, United States, 43081
      • St. Ann's Hospital
    • Youngstown, Ohio, United States, 44501
      • St. Elizabeth Youngstown Hospital
    • Zanesville, Ohio, United States, 43701
      • Genesis Health Care System
  • Oklahoma
    • Lawton, Oklahoma, United States, 73505
      • Cancer Centers of Southwest Oklahoma
  • Oregon
    • Bend, Oregon, United States, 97701
      • Saint Charles Health System
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of UPMC
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group PC-Robert Packer Hospital
    • York, Pennsylvania, United States, 17403
      • WellSpan Health York Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Georgetown, South Carolina, United States, 29440
      • Georgetown Hospital System
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Cancer Care
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75235
      • UT Southwestern/Simmons Cancer Center-Dallas
    • Houston, Texas, United States, 60586
      • MD Anderson Cancer Center
    • Laredo, Texas, United States, 78045
      • Doctors Hospital of Laredo
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Vermont
    • Burlington, Vermont, United States, 05401
      • The University of Vermont Medical Center
  • Virginia
    • Morgantown, Virginia, United States, 26506
      • West Virginia University Medicine
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Massey Cancer Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Overlake Hospital Medical Center
  • Wisconsin
    • Appleton, Wisconsin, United States, 54911
      • ThedaCare Regional Cancer Center -Appleton
    • Burlington, Wisconsin, United States, 53105
      • Aurora Health Care, Aurora Cancer Care
    • Fond Du Lac, Wisconsin, United States, 54937
      • Aurora Health Center - Fond du Lac
    • Germantown, Wisconsin, United States, 53022
      • Aurora Health Care, Germantown Health Center
    • Grafton, Wisconsin, United States, 53024
      • Aurora Health Care, Aurora Cancer Care
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital
    • Green Bay, Wisconsin, United States, 54311
      • BayCare Aurora LLC, Aurora Cancer Care
    • Kenosha, Wisconsin, United States, 49408
      • Aurora Health Care, Aurora Cancer Care
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center
    • Marinette, Wisconsin, United States, 54143
      • Aurora Bay Area Medical Group - Cancer Care Clinic
    • Marinette, Wisconsin, United States, 54143
      • Aurora Health Care, Aurora Cancer Care
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and The Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Health Care, Aurora Cancer Care
    • Milwaukee, Wisconsin, United States, 53215
      • Vince Lombardi Cancer Clinic of Aurora St. Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Health Care, Aurora Cancer Care
    • Oshkosh, Wisconsin, United States, 54904
      • Aurora Health Care, Aurora Cancer Care
    • Racine, Wisconsin, United States, 53406
      • Aurora Health Care, Aurora Cancer Care
    • Sheboygan, Wisconsin, United States, 53081
      • Aurora Health Care, Aurora Cancer Care
    • Summit, Wisconsin, United States, 53066
      • Aurora Health Care, Aurora Cancer Care
    • Two Rivers, Wisconsin, United States, 54241
      • Aurora Health Care, Aurora Cancer Care
    • Wauwatosa, Wisconsin, United States, 53226
      • Aurora Health Care, Aurora Cancer Care
    • West Allis, Wisconsin, United States, 53227
      • Aurora Health Care, Aurora Cancer Care

Participation Criteria

Eligibility Criteria

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 2 years follow-up

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast MRI utilization rate	Determine the rate of use of breast MRI imaging compared to use of other breast imaging techniques	2, 5, and 7 year follow-up
Breast biopsy rate	Determine the rate of biopsies performed during follow-up of patients with DCIS	2, 5, and 7 year follow-up
Radiation rate	Determine the rate of the performance of radiation therapy on patients with DCIS	2, 5, and 7 year follow-up
Chemotherapy rate	Determine the rate of the use of chemotherapy on patients with DCIS	2, 5, and 7 year follow-up
Self-reported co-morbidity	Self-reported diary	6 months, 1 year, and once a year (years 2 through 5)
Adherence to hormonal therapy	Evaluated with a drug diary	6 months, 1 year, and once a year (years 2 through 5)
Symptoms	A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
General pain	Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Breast specific pain	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	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Body image	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	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Decisional regret	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).	Years 1 through 5
Knowledge	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	Baseline and 2 years
Risk perceptions	Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)	Baseline and 2 years
Communication with physicians	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	Baseline
Financial burden	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.	6 months
Employment status	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.	Baseline, 6 months, year 1, and once a year (years 1 through 5)
Concerns about future breast events	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	Baseline and 2 years

Collaborators and Investigators

• Sponsor: Alliance Foundation Trials, LLC.
• Collaborators: Patient-Centered Outcomes Research Institute; M.D. Anderson Cancer Center; Washington University School of Medicine; Dana-Farber Cancer Institute; New York University; Duke University
• 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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: September 19, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimated): October 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Ductal Carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: AFT-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Data will become available July 2023, no end date.
• IPD Sharing Access Criteria: following a formal request by an investigator to and approval from AFT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No