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History of Changes for Study: NCT02926911
Comparison of Operative to Medical Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET)
Latest version (submitted December 7, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 5, 2016 None (earliest Version on record)
2 October 11, 2016 Study Identification and Study Status
3 October 20, 2016 Study Status and Contacts/Locations
4 October 24, 2016 Contacts/Locations and Study Status
5 March 29, 2017 Recruitment Status, Study Status, Outcome Measures, Oversight and Contacts/Locations
6 May 17, 2017 Contacts/Locations, Conditions, References and Study Status
7 August 10, 2017 Contacts/Locations and Study Status
8 September 14, 2017 Study Status and Contacts/Locations
9 October 30, 2017 Contacts/Locations and Study Status
10 January 8, 2018 Contacts/Locations and Study Status
11 March 16, 2018 Study Status and Contacts/Locations
12 April 11, 2018 Study Status and Eligibility
13 June 18, 2018 Contacts/Locations and Study Status
14 August 17, 2018 Study Status, Contacts/Locations and Eligibility
15 August 31, 2018 Eligibility and Study Status
16 February 8, 2019 Contacts/Locations, Study Status and IPDSharing
17 June 20, 2019 IPDSharing, Contacts/Locations and Study Status
18 July 10, 2019 Contacts/Locations and Study Status
19 September 27, 2019 Contacts/Locations and Study Status
20 November 12, 2019 Contacts/Locations and Study Status
21 January 6, 2020 Contacts/Locations and Study Status
22 January 10, 2020 Contacts/Locations and Study Status
23 April 20, 2020 Study Status
24 May 11, 2020 Contacts/Locations and Study Status
25 July 23, 2020 Contacts/Locations and Study Status
26 August 31, 2020 Outcome Measures, Arms and Interventions, Study Description, Study Identification, Eligibility and Study Status
27 November 19, 2020 Contacts/Locations, Study Status and Study Identification
28 April 14, 2021 Contacts/Locations and Study Status
29 August 26, 2021 Contacts/Locations and Study Status
30 October 5, 2021 Contacts/Locations and Study Status
31 December 7, 2021 Contacts/Locations and Study Status
Comparison Format:

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Study NCT02926911
Submitted Date:  October 5, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: AFT-25
Brief Title: Comparison of Operative to Medical Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET)
Official Title: Comparison of Operative to Medical Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2016
Overall Status: Not yet recruiting
Study Start: January 2017
Primary Completion: July 2019 [Anticipated]
Study Completion: July 2021 [Anticipated]
First Submitted: September 19, 2016
First Submitted that
Met QC Criteria:
October 5, 2016
First Posted: October 6, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 5, 2016
Last Update Posted: October 6, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Alliance Foundation Trials, LLC.
Responsible Party: Sponsor
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
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This study looks at the risks and benefits of active surveillance (AS) compared to guideline concordant care (GCC) in the setting of a pragmatic prospective randomized trial for low risk DCIS. Our overarching hypothesis is that management of low-risk Ductal Carcinoma in Situ (DCIS) using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC.
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 surveillance (AS) approach does not yield inferior cancer or quality of life outcomes compared to guideline concordant care (GCC).

Open or close this module Conditions
Conditions: Ductal Carcinoma in Situ
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 1200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Guideline Concordant Care
DCIS - Surgery +/- radiation choice for endocrine therapy (MMG q 12 months x 5 years usual care for recurrent disease)
Guideline Concordant Care
Surgery +/- radiation choice for endocrine therapy
Experimental: Active Surveillance
DCIS - Choice for endocrine therapy (MMG q 6 months x 5 years GCC for invasive progression)
Active Surveillance
Choice for endocrine therapy
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of new diagnoses of ipsilateral invasive cancer in GCC and AS arms at 2 years of follow up
[ Time Frame: At 2 years follow-up ]

Secondary Outcome Measures:
1. Quality of Life (QOL)
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Measured by Short Form (SF)-36
2. Psychological outcomes
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Measured by five dimensions questionnaire (EQ-5D)
3. Generalized anxiety
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Measured by the State Trait Anxiety Inventory (STAI) scale
4. Generalized Depression
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Measured by the Center for Epidemiologic Studies Depression Scale (CES-D) 10
5. Coping
[ Time Frame: Baseline ]

Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).
6. Intolerance of uncertainty
[ Time Frame: Baseline and at 2 years ]

Assessment of feelings of uncertainty using the Intolerance of Uncertainty Scale (Short-form), which has been used in studies of active surveillance in the prostate cancer setting.
7. Mastectomy rate
[ Time Frame: 2, 5, and 7 year follow-up ]

8. Breast conservation rate
[ Time Frame: 2, 5, and 7 year follow-up ]

9. Contralateral invasive cancer rate
[ Time Frame: 2, 5, and 7 year follow-up ]

10. Overall survival rate
[ Time Frame: 2, 5, and 7 year follow-up ]

11. Breast cancer specific survival rate
[ Time Frame: 2, 5, and 7 year follow-up ]

12. Ipsilateral invasive cancer rate in GCC arm at 5 and 7 year follow-up
[ Time Frame: 5 and 7 year follow-up ]

13. Ipsilateral invasive cancer rate in AS arm
[ Time Frame: 5 and 7 year follow-up ]

Other Outcome Measures:
1. Breast MRI utilization rate
[ Time Frame: 2, 5, and 7 year follow-up ]

2. Breast biopsy rate
[ Time Frame: 2, 5, and 7 year follow-up ]

3. Radiation rate
[ Time Frame: 2, 5, and 7 year follow-up ]

4. Chemotherapy rate
[ Time Frame: 2, 5, and 7 year follow-up ]

5. Self-reported co-morbidity
[ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]

Self-reported diary
6. Adherence to hormonal therapy
[ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]

Evaluated with a drug diary
7. Symptoms
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

A modified 19-item version of the Breast Cancer Prevention Trial (BCPT) Symptom Checklist will evaluate commonly reported menopausal symptoms
8. General pain
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Evaluated with the Brief Pain Inventory, a well-validated general measure of pain and disability worst pain, least pain, and interference
9. Breast specific pain
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Breast specific pain will be measured by the Breast Cancer Pain Questionnaire (BCPQ); the BCPQ includes assessment of pain severity, pain frequency (how many days/week), and pain location (breast, arm, side, axilla), from which a Pain Burden Index (PBI) can be calculated
10. Body image
[ Time Frame: Baseline, 6 months, 1 year, and once a year (years 2 through 5) ]

Body image will be evaluated by the Breast-Questionnaire, a validated instrument to evaluate outcomes following surgery, will be used to evaluate satisfaction with body image
11. Decisional regret
[ Time Frame: Years 1 through 5 ]

The Decision Regret Scale will measure how women perceived their DCIS treatment decision. The SURE scale, which is composed of four items from the Decisional Conflict Scale will be used to measure patients' uncertainty about which treatment to choose and factors contributing to uncertainty (feeling uninformed, unclear values, and unsupported in decision-making).
12. Knowledge
[ Time Frame: Baseline and 2 years ]

DCIS and breast cancer knowledge will be measured with items adapted from the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI) as well as questions developed specifically for a study that assessed DCIS knowledge and risk perceptions. The investigators will assess risk perceptions in women with DCIS using questions developed by Lerman and Croyle that will measure risk perceptions in relation to psychosocial outcomes in women with DCIS
13. Risk perceptions
[ Time Frame: Baseline and 2 years ]

Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)
14. Communication with physicians
[ Time Frame: Baseline ]

To assess communication with physicians about DCIS management options, the investigators will adapt items used in a prior study of surgical decision-making, including the extent to which their physician talked to them about AS vs. GCC. Additionally the investigators will ask about sources of information for the management of their DCIS
15. Financial burden
[ Time Frame: 6 months ]

The investigators will adapt items from the National Health Interview Survey and the Cancer Outcomes Research and Surveillance (CanCORS) Study to assess financial burden. The investigators will also ask women to Cancer Care estimate out of pocket expenses attributed to their DCIS diagnosis.
16. Employment status
[ Time Frame: Baseline, 6 months, year 1, and once a year (years 1 through 5) ]

Employment status will be assessed using a measure that is being added to the Alliance Patient Questionnaire as it has been tested and validated in breast cancer populations.
17. Concerns about future breast events
[ Time Frame: Baseline and 2 years ]

Four items from the Quality of Life in Adult Cancer Survivors (QLACS) scale will be adapted to evaluate frequency (1=never; 7=always) of worries about DCIS, including concerns about future breast events and death from DCIS
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 99 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • New diagnosis of DCIS without invasive cancer. Unilateral, bilateral, unifocal, or multifocal DCIS will be eligible, provided that all DCIS meets eligibility criteria
  • No prior history of breast cancer in either breast
  • Age ≥ 40 at time of DCIS diagnosis
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • No contraindication for surgery
  • Pathologic diagnosis of DCIS within 90 days of registration:
    • Histology slides reviewed and diagnosis confirmed by concordance among two clinical pathologists
    • Grade I/II DCIS without invasion or microinvasion
    • Diagnosis confirmed on core needle biopsy or surgical biopsy within 90 days of registration
    • Estrogen Receptor (ER)(+) and/or Progesterone Receptor (PR)(+) by ImmunoHistoChemistry (IHC) (≥ 10% staining or Allred score ≥ 4)
    • Human Epidermal Growth Factor Receptor 2 (HER2) 0, 1+, or 2+ by IHC if HER2 testing is performed
    • Absence of comedo necrosis
  • Required initial laboratory values:
    • Absolute Neutrophil Count (ANC) ≥ 1,000/ul
    • platelet count ≥ 100,000/ul
    • serum creatinine ≤ 1.7 mg/dL
    • serum glucose ≤ 2.5 x Upper Limit of Normal (ULN)
    • serum estradiol assay < 20 pg/ml (required for patients <55 years of age and *less than one year of amenorrhea)
  • At least two sites of biopsy for those cases where mammographic extent of calcifications exceeds 4 cm, both sites fulfilling eligibility criteria for DCIS without invasion or microinvasion
  • 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, or availability of an appropriate professional interpreter at enrollment

Exclusion Criteria:

  • Male DCIS
  • Previous or concurrent diagnosis of invasive breast cancer, including microinvasion
  • Mass on examination or imaging at site of DCIS prior to biopsy yielding diagnosis of DCIS
  • Bloody nipple discharge
  • Mammographic finding of Breast Imaging Reporting and Data System (BIRADS) 4 or greater at site other than that of known DCIS within 6 months of registration
  • Use of investigational cancer agents within 6 weeks prior to diagnosis
  • Any serious and/or unstable pre-existing medical, psychiatric, or other existing condition that would prevent compliance with the trial or consent process
  • Pregnancy
  • Documented history of prior tamoxifen, aromatase inhibitor or raloxifene
Open or close this module Contacts/Locations
Central Contact Person: Shelley Hwang, MD, MPH
Telephone: (919) 684-6849
Email: shelley.hwang@duke.edu
Central Contact Backup: Ann Partridge, MD, MPH
Telephone: (617) 632-3800
Email: ahpartridge@partners.org
Study Officials: Shelley Hwang, MD, MPH
Principal Investigator
Duke University
Ann Partridge, MD, MPH
Study Chair
Dana-Farber Cancer Institute
Thomas Alastair, MD
Study Chair
M.D. Anderson Cancer Center
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
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.
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Links:
Available IPD/Information:

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