Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2-Negative Breast Cancer

This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.

Key Eligibility:
•Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
•HER2 equivocal is not eligible.
•Patients must be high risk by belonging to one of the following risk groups: Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring greater or equal to 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) greater than 25 (completed as standard of care); Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS greater than 25 (screened via S1007 or otherwise); Completion of adjuvant chemotherapy and pathologically 4 or more positive axillary lymph nodes independent of the Oncotype DX® RS in the primary tumor; Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy
•Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging
Phase III
Gary Goodman, M.D.
SWOG (Southwest Oncology Group)
Erik Bailey

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.