Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial
Objective
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.
Study Arms
- Active Comparator: Guideline Concordant Care
- Experimental: Active Surveillance
Eligibility
- 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
- ADH/borderline DCIS
- A patient who has had a lumpectomy with positive margins as part of their treatment for a current DCIS diagnosis is eligible (post-excision mammogram required at enrollment to establish a new baseline)
- 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
- No contraindication for surgery
NCT ID
NCT02926911
