Lotam: A Randomized, Phase III Clinical Trial Of Low-Dose Tamoxifen For Selected Patients With Molecular Low-Risk Early-Stage Breast Cancer
Objective
Primary Objective To evaluate whether the recurrence-free interval (RFI) with low-dose tamoxifen is non-inferior to standard-of-care endocrine therapy among post-menopausal women with early-stage, low molecular risk breast cancer. Hypothesis: Among post-menopausal women with a molecular biomarker of low-risk breast cancer, recurrence-free interval (RFI) with low dose tamoxifen will be non-inferior to standard-of-care endocrine therapy, which is defined as the 5-year RFI rate for the low dose tamoxifen being no worse than 92.5% compared with standard-of-care endocrine therapy.
Secondary Objective(s) To compare endocrine therapy nonadherence rates between treatment arms. To compare the incidence of adverse events between treatment arms, including osteoporosis, fracture, endometrial carcinoma, stroke, and deep vein thrombosis. To compare endocrine therapy-related patient reported symptoms between treatment arms. To compare the invasive disease-free survival between treatment arms. To compare the locoregional breast cancer recurrence between treatment arms. To compare distant recurrence free survival between treatment arms. To compare overall survival between treatment arms. To compare DCIS incidence (ipsilateral and contralateral) between treatment arms. To evaluate the association between radiotherapy modality (no radiation, partial breast radiation, and whole breast radiation) and RFI in each arm. To explore important measures of quality of life that would reasonably be expected to vary by study arm, including global quality of life and reasons for nonadherence. To compare change in mammographic density at two years between treatment arms. To conduct a within patient comparison of automated vs semi-automated mammographic density determination.
