guideline concordant care (GCC) for patients with low-risk
DCIS (see Figure 1, this page). The overarching hypothesis of
the study is that management of low-risk DCIS using an AS
approach does not yield inferior oncologic or quality of life
outcomes when compared with guideline concordant care.
Patient education and close monitoring will be essential
components of the study. Endocrine therapy will be encouraged,
but not required, in the active surveillance group, and patients
will be followed with mammography every six months to assess
for invasive progression. The guideline concordant care group
will be treated with surgery, radiation, endocrine therapy, or a
combination according to usual care guidelines and followed
with mammography every 12 months to assess for recurrent
disease. Both groups will be monitored for 10 years. The primary
outcome will be the proportion of new diagnoses of ipsilateral
invasive cancer in the GCC group and the AS group. Secondary
outcomes will include assessment of quality of life between the
two arms of the study, as well as long-term survival endpoints.
Inclusion in the COMET Trial will be limited to women
ages 40 and older who present with a new diagnosis of DCIS
grades I/II. DCIS must be estrogen receptor (ER)-positive and/
or progesterone receptor (PR)-positive. If human epidermal
growth factor receptor 2 (HER2) testing is performed, the
DCIS must be HER2 0, 1+, or 2+ by immunohistochemistry
(IHC). Male patients, patients with bloody nipple discharge,
pregnant patients, or patients with documented history of
prior tamoxifen, aromatase inhibitor, or raloxifene use will
be excluded. Results from this study will help to determine
whether de-escalation of treatment for low-risk DCIS is a
feasible approach, and how clinical outcomes and quality of
life compare between treatment and surveillance groups.
This trial will recruit 1,200 patients at 100 sites through
the Alliance for Clinical Trials in Oncology, with plans to
include sites from other national adult cooperative groups.
The trial will open for enrollment in February 2017. For
more information on the COMET Trial, contact E. Shelley
Hwang, MD, MPH, at firstname.lastname@example.org. ♦
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ACS CLINICAL RESEARCH PROGRAM