e3 Breast Cancer Study – evaluating everolimus with endocrine therapy
Recruiting | Phase III
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/neu Negative Breast Cancer
To determine if treatment with everolimus plus hormone treatment (after usual care of chemotherapy, surgery, and radiation) will prevent or lengthen the amount of time to recurrence.
- Targeted Therapy: Everolimus (Afinitor, Zortress) or Placebo
- Lab Biomarker Analysis
- Quality of Life questionnaires
- ARM I: Everolimus 20 mg oral pill daily x 1 year (along with MD choice of endocrine therapy)
- ARM II: Placebo oral pill daily x 1 year (along with MD choice of endocrine therapy)
After completion of study therapy, patients are followed up every 6 months for 2 years, then annually thereafter.
Key Participation Requirements
Male or Female
19 years and older
Breast cancer patients who have had surgery and whose cancer has higher risk features (i.e. – positive lymph nodes, high Oncotype DX/MammaPrint score, high grade, and/or large size)
Must be ER and/or PR positive and Her-2 negative
Must have had surgery and completed chemotherapy (before or after surgery). May or may not have had radiation.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
Methodist Health System Trial Code:
For more information, visit the U.S. National Library of Medicine clinical trial database.