Alliance AFT-25 COMET

Clinical Trial Title Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial
Trial Status Closed to Enrollment
Start Date 06/15/2020
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Breast cancer
Description This study looks at the risks and benefits of active monitoring (AM) compared to surgery 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 AM approach does not yield inferior cancer or quality of life outcomes compared to surgery.
Eligibility Criteria

Inclusion Criteria

  • New diagnosis of DCIS without invasive cancer; date of diagnosis defined as the date of the first pathology report that diagnosed the patient with DCIS
  • Unilateral, bilateral, unifocal, or multifocal DCIS
  • No previous history of breast cancer (DCIS or invasive cancer) in either breast prior to current DCIS diagnosis
  • 40 years of age or older at time of DCIS diagnosis
  • ECOG performance status 0 or 1

Exclusion Criteria

  • All grade III DCIS
  • Concurrent diagnosis of invasive or microinvasive breast cancer in either breast
  • Use of investigational cancer agents within 6 weeks prior to diagnosis
  • Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene in last 6 months

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Principal Investigator Nathalie Johnson, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail