Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial For Low Risk DCIS: A Phase III Prospective Randomized Trial

To study 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 DCIS using an AS approach does not yield inferior cancer or quality of life outcomes compared to GCC. To assess whether 2-year ipsilateral invasive cancer rate for AS is non-inferior to that for GCC. To determine whether AS is non-inferior to GCC for the following outcomes: 2-year mastectomy rate, breast conservation rate; 2-year contralateral invasive breast cancer rate; 2-year overall survival and breast cancer specific survival; health-related QOL at 1 year, 2 years; anxiety and depression and other psychosocial outcomes at 1 year, 2 years. Multicenter Phase III Prospective Randomized Trial comparing guideline concordant care to active surveillance with option of endocrine therapy for low risk ductal carcinoma in situ (DCIS).