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

Primary Purpose

DCIS, Ductal Carcinoma in Situ

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgery
Active Monitoring
Sponsored by
Alliance Foundation Trials, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for DCIS focused on measuring Ductal Carcinoma

Eligibility Criteria

40 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Providence Alaska Medical Center
  • Mayo Clinic
  • City of Hope
  • Cedars-Sinai Medical Center
  • Sharp Memorial Hospital
  • Kaiser Permanente Medical Center
  • Colorado Cancer Research Program
  • Saint Joseph Hospital- Cancer Centers of Colorado
  • Smilow Cancer Hospital at Yale-New Haven
  • MedStar Washington Hospital Center
  • Memorial Healthcare System
  • Mayo Clinic Florida
  • University of Hawaii Cancer Center
  • Kootenai Health
  • John H Stroger Jr Hospital of Cook County
  • University of Chicago Medical Center
  • Advocate Illinois Masonic Medical Center
  • NorthShore University HealthSystem-Evanston Hospital
  • Ingalls Memorial Hospital
  • Illinois Cancer Care
  • OSF Saint Anthony Medical Center
  • Carle Cancer Center
  • Medical Oncology and Hematology Associates - Des Moines
  • University of Iowa/Holden Comprehensive Cancer Center
  • University of Kansas Cancer Center
  • St. Elizabeth Healthcare Edgewood
  • University of Kentucky/Markey Cancer Center
  • Mary Bird Perkins Cancer Center
  • Ochsner Medical Center Jefferson
  • Eastern Maine Medical Center Cancer Care
  • Maine Center for Cancer Medicine-Scarborough
  • New England Cancer Specialists
  • Anne Arundel Medical Center
  • University of Maryland - Greenebaum Comprehensive Cancer Center
  • Dana-Farber Cancer Institute
  • Saint Joseph Mercy Hospital
  • Henry Ford Hospital
  • Cancer Research Consortium of West Michigan
  • Beaumont NCORP
  • Masonic Cancer Center, University of Minnesota
  • Mayo Clinic
  • Metro MN Community Oncology Research Consortium (MMCORC)
  • Washington University - Siteman Cancer Center
  • Community Hospital of Anaconda
  • Billings Clinic
  • Bozeman Health
  • Benefis Sletten Cancer Institute
  • Kalispell Regional Medical Center
  • Community Medical Center
  • University of Nebraska Medical Center
  • New Hampshire Oncology Hematology PA
  • Englewood Hospital and Medical Center
  • Hackensack University Medical Center
  • Atlantic Health System / Morristown Medical Center
  • Jersey Shore University Medical Center
  • The Valley Hospital - Luckow Pavilion
  • New Mexico Cancer Care Alliance
  • Montefiore-Einstein Center for Cancer Care at Montefiore Medical Park
  • Roswell Park Cancer Institute
  • New York-Presbyterian Weill Cornell Medical Center
  • Mount Sinai Hospital
  • State University of New York Upstate Medical University
  • UNC Lineberger Comprehensive Cancer Center
  • Levine Cancer Institute
  • Novant Health Presbyterian Medical Center
  • Duke University Medical Center
  • Cape Fear Valley Health System
  • Southeastern Medical Oncology Center
  • Cone Health Cancer Center
  • Novant Health Breast Surgery - Greensboro
  • East Carolina University
  • Carolina East Medical Center
  • Rex Cancer Center
  • Wake Forest Baptist Medical Center
  • Strecker Cancer Center - Belpre
  • Dayton Physicians-Miami Valley Hospital South
  • Ohio State University Comprehensive Cancer Center
  • Ohio State University Comprehensive Cancer Center
  • Mount Carmel East Hospital
  • Columbus Oncology & Hematology INC
  • Riverside Methodist Hospital
  • Grant Medical Center
  • MidOhio Oncology Hematology, Mark H. Zangmeister Center
  • Mount Carmel West Hospital
  • Doctors Hospital
  • Dayton Physicians-Miami Valley Hospital North
  • Grady Hospital
  • OhioHealth Grady - Delaware Health Center
  • Armes Family Cancer Center
  • Dayton Physicians-Atrium
  • Wayne Hospital
  • Kettering Medical Center
  • OhioHealth Mansfield Hospital
  • Marietta Memorial Hospital
  • OhioHealth Marion General Hospital
  • Licking Memorial Hospital
  • St. Ann's Hospital
  • St. Elizabeth Youngstown Hospital
  • Genesis Health Care System
  • Cancer Centers of Southwest Oklahoma
  • Saint Charles Health System
  • Magee-Womens Hospital of UPMC
  • Guthrie Medical Group PC-Robert Packer Hospital
  • WellSpan Health York Cancer Center
  • Rhode Island Hospital
  • Medical University of South Carolina
  • Georgetown Hospital System
  • Greenville Memorial Hospital
  • Baptist Cancer Care
  • UT Southwestern/Simmons Cancer Center-Dallas
  • Baylor University Medical Center
  • MD Anderson Cancer Center
  • Doctors Hospital of Laredo
  • Huntsman Cancer Institute
  • The University of Vermont Medical Center
  • West Virginia University Medicine
  • Sentara Norfolk General Hospital
  • Virginia Commonwealth University Massey Cancer Center
  • Overlake Hospital Medical Center
  • ThedaCare Regional Cancer Center -Appleton
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Center - Fond du Lac
  • Aurora Health Care, Germantown Health Center
  • Aurora Health Care, Aurora Cancer Care
  • Saint Vincent Hospital
  • BayCare Aurora LLC, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • University of Wisconsin Carbone Cancer Center
  • Aurora Bay Area Medical Group - Cancer Care Clinic
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Vince Lombardi Cancer Clinic of Aurora St. Luke's Medical Center
  • Froedtert and the Medical College of Wisconsin
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care
  • Aurora Health Care, Aurora Cancer Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Surgery

Active Monitoring

Arm Description

DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)

DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2016
Last Updated
September 13, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02926911
Brief Title
Comparing an Operation to Monitoring, With or Without Endocrine Therapy (COMET) Trial For Low Risk DCIS
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
July 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
DCIS, Ductal Carcinoma in Situ
Keywords
Ductal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)
Arm Title
Active Monitoring
Arm Type
Experimental
Arm Description
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Intervention Type
Other
Intervention Name(s)
Surgery
Intervention Description
Surgery +/- radiation choice for endocrine therapy
Intervention Type
Other
Intervention Name(s)
Active Monitoring
Intervention Description
Choice for endocrine therapy
Primary Outcome Measure Information:
Title
Proportion of new diagnoses of ipsilateral invasive cancer in surgery and AM arms at 2 years of follow up
Description
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
Time Frame
At 2 years follow-up
Secondary Outcome Measure Information:
Title
Quality of Life (QOL)
Description
Measured by Short Form (SF)-36
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Psychological outcomes
Description
Measured by five dimensions questionnaire (EQ-5D)
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Generalized anxiety
Description
Measured by the State Trait Anxiety Inventory (STAI) scale
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Generalized Depression
Description
Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Coping
Description
Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).
Time Frame
Baseline
Title
Intolerance of uncertainty
Description
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.
Time Frame
Baseline and at 2 years
Title
Mastectomy rate
Description
To compare the impact of surgery vs. AM on the number of mastectomies performed in patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Breast conservation rate
Description
To compare the impact of surgery vs. AM on the number of breast conservation surgeries performed in patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Contralateral invasive cancer rate
Description
To compare the impact of surgery vs. AM on the rate of development of contralateral invasive cancer in patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Overall survival rate
Description
To compare the impact of surgery vs. AM on the overall survival rate in patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Breast cancer specific survival rate
Description
To compare the impact of surgery vs. AM on the breast cancer specific survival rate in patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Ipsilateral invasive cancer rate in surgery arm at 5 and 7 year follow-up
Description
To determine the number of DCIS patients in the surgery arm that develop ipsilateral invasive cancer
Time Frame
5 and 7 year follow-up
Title
Ipsilateral invasive cancer rate in AM arm
Description
To determine the number of DCIS patients in the AM arm that develop ipsilateral invasive cancer
Time Frame
5 and 7 year follow-up
Other Pre-specified Outcome Measures:
Title
Breast MRI utilization rate
Description
Determine the rate of use of breast MRI imaging compared to use of other breast imaging techniques
Time Frame
2, 5, and 7 year follow-up
Title
Breast biopsy rate
Description
Determine the rate of biopsies performed during follow-up of patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Radiation rate
Description
Determine the rate of the performance of radiation therapy on patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Chemotherapy rate
Description
Determine the rate of the use of chemotherapy on patients with DCIS
Time Frame
2, 5, and 7 year follow-up
Title
Self-reported co-morbidity
Description
Self-reported diary
Time Frame
6 months, 1 year, and once a year (years 2 through 5)
Title
Adherence to hormonal therapy
Description
Evaluated with a drug diary
Time Frame
6 months, 1 year, and once a year (years 2 through 5)
Title
Symptoms
Description
A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
General pain
Description
Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Breast specific pain
Description
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
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Body image
Description
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
Time Frame
Baseline, 6 months, 1 year, and once a year (years 2 through 5)
Title
Decisional regret
Description
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).
Time Frame
Years 1 through 5
Title
Knowledge
Description
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
Time Frame
Baseline and 2 years
Title
Risk perceptions
Description
Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
Time Frame
Baseline and 2 years
Title
Communication with physicians
Description
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
Time Frame
Baseline
Title
Financial burden
Description
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.
Time Frame
6 months
Title
Employment status
Description
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.
Time Frame
Baseline, 6 months, year 1, and once a year (years 1 through 5)
Title
Concerns about future breast events
Description
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
Time Frame
Baseline and 2 years

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
12381707
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.
Results Reference
background
PubMed Identifier
16319971
Citation
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.
Results Reference
background
PubMed Identifier
21390494
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.
Results Reference
background
PubMed Identifier
8096941
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.
Results Reference
background
PubMed Identifier
30862637
Citation
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.
Results Reference
derived

Learn more about this trial

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

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