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

Ductal Carcinoma in Situ Clinical Trial

— COMET  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02926911
• Other study ID #: AFT-25
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: July 2028

Study information

• Verified date: April 2023
• Source: Alliance Foundation Trials, LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 997
• Est. completion date: July 2028
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• DCIS
• Ductal Carcinoma in Situ

Intervention

Other:
• Surgery
Surgery +/- radiation choice for endocrine therapy
• Active Monitoring
Choice for endocrine therapy

Locations

Country	Name	City	State
United States	New Mexico Cancer Care Alliance	Albuquerque	New Mexico
United States	Community Hospital of Anaconda	Anaconda	Montana
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	Saint Joseph Mercy Hospital	Ann Arbor	Michigan
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	ThedaCare Regional Cancer Center -Appleton	Appleton	Wisconsin
United States	University of Maryland - Greenebaum Comprehensive Cancer Center	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	Overlake Hospital Medical Center	Bellevue	Washington
United States	Strecker Cancer Center - Belpre	Belpre	Ohio
United States	Saint Charles Health System	Bend	Oregon
United States	Billings Clinic	Billings	Montana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Bozeman Health	Bozeman	Montana
United States	Eastern Maine Medical Center Cancer Care	Brewer	Maine
United States	Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Aurora Health Care, Aurora Cancer Care	Burlington	Wisconsin
United States	The University of Vermont Medical Center	Burlington	Vermont
United States	Dayton Physicians-Miami Valley Hospital South	Centerville	Ohio
United States	UNC Lineberger Comprehensive Cancer Center	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	John H Stroger Jr Hospital of Cook County	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Columbus Oncology & Hematology INC	Columbus	Ohio
United States	Doctors Hospital	Columbus	Ohio
United States	Grant Medical Center	Columbus	Ohio
United States	MidOhio Oncology Hematology, Mark H. Zangmeister Center	Columbus	Ohio
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	Mount Carmel West Hospital	Columbus	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Baylor University Medical Center	Dallas	Texas
United States	UT Southwestern/Simmons Cancer Center-Dallas	Dallas	Texas
United States	Dayton Physicians-Miami Valley Hospital North	Dayton	Ohio
United States	Grady Hospital	Delaware	Ohio
United States	OhioHealth Grady - Delaware Health Center	Delaware	Ohio
United States	Colorado Cancer Research Program	Denver	Colorado
United States	Medical Oncology and Hematology Associates - Des Moines	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Elizabeth Healthcare Edgewood	Edgewood	Kentucky
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois
United States	Cape Fear Valley Health System	Fayetteville	North Carolina
United States	Armes Family Cancer Center	Findlay	Ohio
United States	Aurora Health Center - Fond du Lac	Fond Du Lac	Wisconsin
United States	Dayton Physicians-Atrium	Franklin	Ohio
United States	Georgetown Hospital System	Georgetown	South Carolina
United States	Aurora Health Care, Germantown Health Center	Germantown	Wisconsin
United States	Southeastern Medical Oncology Center	Goldsboro	North Carolina
United States	Aurora Health Care, Aurora Cancer Care	Grafton	Wisconsin
United States	Cancer Research Consortium of West Michigan	Grand Rapids	Michigan
United States	Benefis Sletten Cancer Institute	Great Falls	Montana
United States	BayCare Aurora LLC, Aurora Cancer Care	Green Bay	Wisconsin
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	Cone Health Cancer Center	Greensboro	North Carolina
United States	Novant Health Breast Surgery - Greensboro	Greensboro	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Greenville Memorial Hospital	Greenville	South Carolina
United States	Wayne Hospital	Greenville	Ohio
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Memorial Healthcare System	Hollywood	Florida
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	New Hampshire Oncology Hematology PA	Hooksett	New Hampshire
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa/Holden Comprehensive Cancer Center	Iowa City	Iowa
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	Aurora Health Care, Aurora Cancer Care	Kenosha	Wisconsin
United States	Kettering Medical Center	Kettering	Ohio
United States	Saint Joseph Hospital- Cancer Centers of Colorado	Lafayette	Colorado
United States	Doctors Hospital of Laredo	Laredo	Texas
United States	Cancer Centers of Southwest Oklahoma	Lawton	Oklahoma
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	OhioHealth Mansfield Hospital	Mansfield	Ohio
United States	Marietta Memorial Hospital	Marietta	Ohio
United States	Aurora Bay Area Medical Group - Cancer Care Clinic	Marinette	Wisconsin
United States	Aurora Health Care, Aurora Cancer Care	Marinette	Wisconsin
United States	OhioHealth Marion General Hospital	Marion	Ohio
United States	Baptist Cancer Care	Memphis	Tennessee
United States	Aurora Health Care, Aurora Cancer Care	Milwaukee	Wisconsin
United States	Aurora Health Care, Aurora Cancer Care	Milwaukee	Wisconsin
United States	Froedtert and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Vince Lombardi Cancer Clinic of Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota
United States	Community Medical Center	Missoula	Montana
United States	West Virginia University Medicine	Morgantown	Virginia
United States	Atlantic Health System / Morristown Medical Center	Morristown	New Jersey
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Carolina East Medical Center	New Bern	North Carolina
United States	Smilow Cancer Hospital at Yale-New Haven	New Haven	Connecticut
United States	Ochsner Medical Center Jefferson	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	New York-Presbyterian Weill Cornell Medical Center	New York	New York
United States	Licking Memorial Hospital	Newark	Ohio
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Aurora Health Care, Aurora Cancer Care	Oshkosh	Wisconsin
United States	The Valley Hospital - Luckow Pavilion	Paramus	New Jersey
United States	Illinois Cancer Care	Peoria	Illinois
United States	Mayo Clinic	Phoenix	Arizona
United States	Magee-Womens Hospital of UPMC	Pittsburgh	Pennsylvania
United States	Kootenai Health	Post Falls	Idaho
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Aurora Health Care, Aurora Cancer Care	Racine	Wisconsin
United States	Rex Cancer Center	Raleigh	North Carolina
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	OSF Saint Anthony Medical Center	Rockford	Illinois
United States	Beaumont NCORP	Royal Oak	Michigan
United States	Washington University - Siteman Cancer Center	Saint Louis	Missouri
United States	Metro MN Community Oncology Research Consortium (MMCORC)	Saint Louis Park	Minnesota
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Sharp Memorial Hospital	San Diego	California
United States	Guthrie Medical Group PC-Robert Packer Hospital	Sayre	Pennsylvania
United States	Maine Center for Cancer Medicine-Scarborough	Scarborough	Maine
United States	New England Cancer Specialists	Scarborough	Maine
United States	Aurora Health Care, Aurora Cancer Care	Sheboygan	Wisconsin
United States	Aurora Health Care, Aurora Cancer Care	Summit	Wisconsin
United States	State University of New York Upstate Medical University	Syracuse	New York
United States	Aurora Health Care, Aurora Cancer Care	Two Rivers	Wisconsin
United States	Carle Cancer Center	Urbana	Illinois
United States	Kaiser Permanente Medical Center	Vallejo	California
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Aurora Health Care, Aurora Cancer Care	Wauwatosa	Wisconsin
United States	Aurora Health Care, Aurora Cancer Care	West Allis	Wisconsin
United States	St. Ann's Hospital	Westerville	Ohio
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina
United States	WellSpan Health York Cancer Center	York	Pennsylvania
United States	St. Elizabeth Youngstown Hospital	Youngstown	Ohio
United States	Genesis Health Care System	Zanesville	Ohio

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Breast biopsy rate	Determine the rate of biopsies performed during follow-up of patients with DCIS	2, 5, and 7 year follow-up
Other	Radiation rate	Determine the rate of the performance of radiation therapy on patients with DCIS	2, 5, and 7 year follow-up
Other	Chemotherapy rate	Determine the rate of the use of chemotherapy on patients with DCIS	2, 5, and 7 year follow-up
Other	Self-reported co-morbidity	Self-reported diary	6 months, 1 year, and once a year (years 2 through 5)
Other	Adherence to hormonal therapy	Evaluated with a drug diary	6 months, 1 year, and once a year (years 2 through 5)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Other	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
Other	Risk perceptions	Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)	Baseline and 2 years
Other	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
Other	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
Other	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)
Other	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
Primary	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	Quality of Life (QOL)	Measured by Short Form (SF)-36	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Secondary	Psychological outcomes	Measured by five dimensions questionnaire (EQ-5D)	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Secondary	Generalized anxiety	Measured by the State Trait Anxiety Inventory (STAI) scale	Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Secondary	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)
Secondary	Coping	Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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