5414S-13: S1207 e3

SWOG 1207: Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer – e3 Breast Cancer Study

Type of Study
Cancer (Oncology) - Breast
Location
Swedish Cancer Institute
Short Description
Purpose: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • 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
  • Patients must not have inflammatory breast cancer and must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral breast cancers are allowed
  • 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 ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care)
    • Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS > 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; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
  • Patients must be able to take oral medications
  • Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 courses (a course of weekly paclitaxel is considered 3 doses); patients must be registered within 21 weeks after completion of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
  • Patients must not be receiving or planning to receive trastuzumab
  • Concurrent bisphosphonate therapy is allowed
  • Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org