Grants and Contracts Details
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).
|Effective start/end date||11/25/19 → 2/14/24|
- Alliance Foundation Trials LLC: $10,500.00
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