Trastuzumab With or Without Everolimus in Estrogen Receptor-Positive Metastatic Breast Cancer
Summary
The purpose of the study is to find out if trastuzumab alone or trastuzumab in combination with everolimus is effective in metastatic breast cancers that are no longer controlled by hormonal therapies.
Description
The purpose of this study is to investigate if trastuzumab alone or in combination with everolimus is effective for breast cancers that are no longer controlled with (resistant to) hormonal therapies, and have small to moderate amounts of HER2/neu. There is no standard of care for your disease once it becomes resistant to hormonal therapy, and many patients are treated with chemotherapy. Trastuzumab alone, or in combination with everolimus, has not been previously used to treat breast cancers than are resistant to hormonal therapies and have small to moderate amounts of HER2/neu.
In this study participants will be randomized 50:50 to receive trastuzumab alone, or to trastuzumab in combination with everolimus. Trastuzumab is widely used to treat all stages of breast cancer, and is currently approved for the treatment of early and advanced breast cancer that have very high amounts of HER2/neu. Everolimus is being evaluated in multiple clinical trials of patients with breast cancer. You will continue on the most recent hormonal therapy you received prior to entering this study.
It is hoped that trastuzumab alone, or trastuzumab in combination with everolimus, may cause your tumor to stop growing or possibly to cause your tumor to shrink. This assessment will be based on measuring changes in the size of your tumor. You will be requested to have a biopsy of one of your metastatic areas prior to study entry to measure the amount of HER2/neu protein in your tumor.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Breast Cancer
Intervention
Trastuzumab (Herceptin), Trastuzumab (Herceptin) plus Everolimus
Location
Emory University Winship Cancer Institute
Atlanta
Georgia
United States
30322
Status
Recruiting
Source
Emory University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00912340
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.
Breast Neoplasms
Tumors or cancer of the human BREAST.
Brca1 Protein
The phosphoprotein encoded by the BRCA1 gene (GENE, BRCA1). In normal cells the BRCA1 protein is localized in the nucleus, whereas in the majority of breast cancer cell lines and in malignant pleural effusions from breast cancer patients, it is localized mainly in the cytoplasm. (Science 1995;270(5237):713,789-91)
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