A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer.

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.

Secondary Objectives:
- 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.

For further information about clinical trials, please contact us at 732-235-7356.