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Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS (COMET)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Alliance Foundation Trials, LLC.
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
Information provided by (Responsible Party):
Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier:
NCT02926911
First received: September 19, 2016
Last updated: May 17, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
DCIS
Ductal Carcinoma in Situ
Other: Guideline Concordant Care
Other: Active Surveillance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

Further study details as provided by Alliance Foundation Trials, LLC.:

Primary Outcome Measures:
  • 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 ]
    To compare the number of patients that develop ipsilateral invasive cancer that received guidance concordant care to the number of patients that were placed on active surveillance after 2 years of follow-up


Secondary Outcome Measures:
  • 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

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

  • 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

  • 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

  • Coping [ Time Frame: Baseline ]
    Coping evaluated using the Brief COPE, a shortened form of the COPE Inventory, inclusive of 28 items (14 subscales).

  • 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.

  • Mastectomy rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of GCC vs. AS on the number of mastectomies performed in patients with DCIS

  • Breast conservation rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of GCC vs. AS on the number of breast conservation surgeries performed in patients with DCIS

  • Contralateral invasive cancer rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of GCC vs. AS on the rate of development of contralateral invasive cancer in patients with DCIS

  • Overall survival rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of GCC vs. AS on the overall survival rate in patients with DCIS

  • Breast cancer specific survival rate [ Time Frame: 2, 5, and 7 year follow-up ]
    To compare the impact of GCC vs. AS on the breast cancer specific survival rate in patients with DCIS

  • Ipsilateral invasive cancer rate in GCC arm at 5 and 7 year follow-up [ Time Frame: 5 and 7 year follow-up ]
    To determine the number of DCIS patients in the GCC arm that develop ipsilateral invasive cancer

  • Ipsilateral invasive cancer rate in AS arm [ Time Frame: 5 and 7 year follow-up ]
    To determine the number of DCIS patients in the AS arm that develop ipsilateral invasive cancer


Other Outcome Measures:
  • Breast MRI utilization rate [ Time Frame: 2, 5, and 7 year follow-up ]
    Determine the rate of use of breast MRI imaging compared to use of other breast imaging techniques

  • Breast biopsy rate [ Time Frame: 2, 5, and 7 year follow-up ]
    Determine the rate of biopsies performed during follow-up of patients with DCIS

  • Radiation rate [ Time Frame: 2, 5, and 7 year follow-up ]
    Determine the rate of the performance of radiation therapy on patients with DCIS

  • Chemotherapy rate [ Time Frame: 2, 5, and 7 year follow-up ]
    Determine the rate of the use of chemotherapy on patients with DCIS

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

  • Adherence to hormonal therapy [ Time Frame: 6 months, 1 year, and once a year (years 2 through 5) ]
    Evaluated with a drug diary

  • 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

  • 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

  • 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

  • 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

  • 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).

  • 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

  • Risk perceptions [ Time Frame: Baseline and 2 years ]
    Measured by the Breast Cancer Surgery Decision Quality Instrument (BCS-DQI)

  • 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

  • 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.

  • 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.

  • 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


Estimated Enrollment: 1200
Actual Study Start Date: February 22, 2017
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
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)
Other: 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)
Other: Active Surveillance
Choice for endocrine therapy

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).

  Eligibility

Ages Eligible for Study:   40 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02926911

Contacts
Contact: Thomas Lynch, PhD (443) 286-4595 thomas.lynch2@duke.edu
Contact: Shelley Hwang, MD, MPH (919) 684-6849 shelley.hwang@duke.edu

Locations
United States, Colorado
Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
Contact: Jessica Bloomfield         
Principal Investigator: Keren Sturtz, MD         
United States, Maryland
Anne Arundel Medical Center Recruiting
Annapolis, Maryland, United States, 21401
Contact: Laura Martino    443-481-5749    lmartino@aahs.org   
Contact: Emily Ross    (443) 481-4392      
Principal Investigator: Wen Liang, MD         
United States, New Hampshire
New Hampshire Oncology Hematology PA Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Ali Fleury, BA         
Principal Investigator: Douglas Weckstein, MD         
United States, Oklahoma
Cancer Centers of Southwest Oklahoma Recruiting
Lawton, Oklahoma, United States, 73505
Contact: Susie Mccoy    580-536-2121    susie.mccoy@ccswok.org   
Principal Investigator: Jose Najera, MD         
Sponsors and Collaborators
Alliance Foundation Trials, LLC.
Patient-Centered Outcomes Research Institute
Duke University
Dana-Farber Cancer Institute
M.D. Anderson Cancer Center
New York University
Washington University School of Medicine
Investigators
Principal Investigator: Shelley Hwang, MD, MPH Duke University
Study Chair: Ann Partridge, MD, MPH Dana-Farber Cancer Institute
Study Chair: Alastair Thompson, MD M.D. Anderson Cancer Center
  More Information

Publications:
Responsible Party: Alliance Foundation Trials, LLC.
ClinicalTrials.gov Identifier: NCT02926911     History of Changes
Other Study ID Numbers: AFT-25
Study First Received: September 19, 2016
Last Updated: May 17, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient medical information both, associated with biologic specimens or not, is confidential and may only be disclosed to third parties as permitted by the Informed Consent Form (ICF) (or separate authorization for use and disclosure of personal health information) which has been signed by the patient, unless permitted or required by law. Data derived from biologic specimen analysis on individual patients will in generally not be provided to study investigators unless a request for research use is granted. The overall results of any research conducted using biologic specimens will be available in accordance with the effective Alliance Foundation Trial (AFT) policy on study data publication.

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

Keywords provided by Alliance Foundation Trials, LLC.:
Ductal Carcinoma

Additional relevant MeSH terms:
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal
Carcinoma in Situ
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on May 24, 2017