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

What we are studying

The purpose of this study is to compare the risks and benefits of the usual treatment approach for DCIS compared to the close monitoring approach.

Who is Eligible

  • Genders:
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 40+

Eligibility Criteria

  • New diagnosis of DCIS without invasive cancer
  • No prior history of breast cancer in either breast
  • Age ? 40 at time of DCIS diagnosis
  • ECOG performance status 0 or 1
  • No contraindication for surgery
  • Pathologic diagnosis of DCIS within 90 days of registration
  • Grade I/II DCIS without invasion or microinvasion
  • Diagnosis confirmed on core needle biopsy or surgical biopsy within 90 days of registration
  • ER(+) and/or PR(+) by IHC (? 10% staining or Allred score ? 4)
  • HER2 0
  • 1+
  • Or 2+ by IHC if HER2 testing is performed
  • Absence of comedonecrosis
  • Required initial laboratory values
  • 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

What is involved

  • 1 eligibility screening for tests and observations (weight and height
  • Pulse
  • Blood pressure
  • Randomization)
  • 13 history and physical (1 at eligibility
  • 10 at 0-5 years every 6 months
  • 2 at 5-7 years every 12 months)
  • 1 laboratory studies (1 CBC
  • Differential
  • Platelets
  • 1 serum creatinine
  • 1 glucose
  • 1 serum/urine HCG)
  • 6 contralateral MMG (1 at eligibility
  • 5 at 12 months
  • Then every 12 months years 1-5) 11 ipsilateral MMG for AS arm (1 at eligibility
  • 10 every 6 months years 0-5)
  • 6 ipsilateral MMG for GCC arm (1 at eligibility
  • 5 at 12 months
  • Then every 12 months years 1-5)
  • 2 bilateral MMG
  • Unknown amount of therapeutic procedures (if patient opts in: surgery for GCC arm
  • Days 1-180
  • Radiation for GCC arm
  • Days 1-180
  • Endocrine therapy discussion/initiation
  • Days 1-180)

Compensation

Participants will not be paid for participating in this study. Parking will be validated for all study-related visits.

Contact Information

Study Coordinator
Stacey Lewis
Email
stalewis@wakehealth.edu
Phone
336-713-6927

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.