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  • 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)

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Patient-centred medicine
Protocol
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)
  1. E Shelley Hwang1,
  2. Terry Hyslop2,
  3. Thomas Lynch1,
  4. Elizabeth Frank3,
  5. Donna Pinto3,
  6. Desiree Basila3,
  7. Deborah Collyar3,
  8. Antonia Bennett4,
  9. Celia Kaplan5,
  10. Shoshana Rosenberg6,
  11. Alastair Thompson7,
  12. Anna Weiss8,
  13. Ann Partridge6
  1. 1 Department of Surgery, Division of Surgical Oncology, Duke University, Durham, North Carolina, USA
  2. 2 Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA
  3. 3 Patient Leadership Team, COMET Study
  4. 4 Department of Health Policy and Management, University of North Carolina, Chapel Hill, North Carolina, USA
  5. 5 Department of Medicine, University of California, San Francisco, California, USA
  6. 6 Department of Medicine, Brigham and Women’s Hospital, Dana Farber Cancer Institute, Boston, Massachusetts, USA
  7. 7 Department of Breast Surgery, Division of Surgical Oncology, Baylor College of Medicine, Houston, Texas, USA
  8. 8 Alliance Foundation Trials, Boston, Massachusetts, USA
  1. Correspondence to Dr Thomas Lynch; thomas.lynch2{at}duke.edu

Abstract

Introduction Ductal carcinoma in situ (DCIS) is a non-invasive non-obligate precursor of invasive breast cancer. With guideline concordant care (GCC), DCIS outcomes are at least as favourable as some other early stage cancer types such as prostate cancer, for which active surveillance (AS) is a standard of care option. However, AS has not yet been tested in relation to DCIS. The goal of the COMET (Comparison of Operative versus Monitoring and Endocrine Therapy) trial for low-risk DCIS is to gather evidence to help future patients consider the range of treatment choices for low-risk DCIS, from standard therapies to AS. The trial will determine whether there may be some women who do not substantially benefit from current GCC and who could thus be safely managed with AS. This protocol is version 5 (11 July 2018). Any future protocol amendments will be submitted to Quorum Centralised Institutional Review Board/local institutional review boards for approval via the sponsor of the study (Alliance Foundation Trials).

Methods and analysis COMET is a phase III, randomised controlled clinical trial for patients with low-risk DCIS. The primary outcome is ipsilateral invasive breast cancer rate in women undergoing GCC compared with AS. Secondary objectives will be to compare surgical, oncological and patient-reported outcomes. Patients randomised to the GCC group will undergo surgery as well as radiotherapy when appropriate; those in the AS group will be monitored closely with surgery only on identification of invasive breast cancer. Patients in both the GCC and AS groups will have the option of endocrine therapy. The total planned accrual goal is 1200 patients.

Ethics and dissemination The COMET trial will be subject to biannual formal review at the Alliance Foundation Data Safety Monitoring Board meetings. Interim analyses for futility/safety will be completed annually, with reporting following Consolidated Standards of Reporting Trials (CONSORT) guidelines for non-inferiority trials.

Trial registration number NCT02926911; Pre-results.

  • ductal carcinoma in situ
  • active surveillance
  • breast cancer
  • clinical trial
  • non-invasive
  • surgery

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-026797

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    Footnotes

    • Contributors The PI and first author of this paper (ESH) was instrumental in the compilation of this study protocol. Each co-author (TH, TL, EF, DP, DB, DC, AB, CK, SR, AT, AW, AP) contributed equally to subsequent development of the protocol. EF, DP, DB and DC form the COMET Study Patient Leadership Team.

    • Funding This work was supported through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1505-30497). The sponsor of the COMET study is Alliance Foundation Trials (https://alliancefoundationtrials.org). Correlative studies are supported by the Breast Cancer Research Foundation (BCRF-17-173). ESH is supported by a Duke Comprehensive Cancer Center Grant (5P30CA014236-44). Patient-reported outcome data are collected via the University of North Carolina Patient Reported Outcomes Core, which is supported in part by grants from the National Institute of Health (DK056350) to the University of North Carolina Nutrition Obesity Research Center, and the US National Cancer Institute (P30 CA016086) to the Lineberger Comprehensive Cancer Center.

    • Disclaimer All statements in this article are solely those of the authors and do not necessarily represent the views of PCORI, its Board of Governors or Methodology Committee.

    • Competing interests None declared.

    • Ethics approval Quorum Centralised Institutional Review Board.

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Patient consent for publication Not required.