Cancer

Title
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
205076041713
Number of Participants
3,500
Principal Investigator

Kathy S. Albain

M.D.
Hematology/Oncology
Professor
Eligibility

• 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.

Purpose

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.

Enrollment

(708) 327-3102

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