Treatment With Everolimus, an Investigational Drug, Plus Hormone Treatment After Chemotherapy in Patients with Hormone Receptor-positive and Her2/Neu Negative Breast Cancer
Trial Number
Number of Participants
Principal Investigator

Kathy S. Albain


• Patients with the following criteria may be eligible: patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive ER and/or PR status, and negative HER-2 and have standard adjuvant endocrine therapy planned; patients must not have inflammatory breast cancer and must not have metastatic breast cancer (Stage IV disease); patients must be high-risk by belonging to one of the following risk groups: negative lymph nodes, tumor measuring = 2 cm in greatest diameter, and Recurrence Score > 25; 1-3 positive lymph nodes, and Recurrence Score > 25; 4 or more positive lymph nodes;patients must have completed adjuvant chemotherapy (neoadjuvant is allowed for patients with 4+ positive lymph nodes); patients must not be receiving/planning to receive trastuzumab; patients must have adequate bone marrow, hepatic, and renal function and must not have any Grade III/IV cardiac disease or uncontrolled diabetes; patients must have a performance status of 0-2; patients must have a fasting cholesterol = 300 mg/dl and triglycerides = 2.5 x IULN; patients must not be pregnant or nursing; no other prior malignancy is allowed except for adequately treated basal/squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.


The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.


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