Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title: Phase II Trial of EVEROLIMUS ± Trastuzumab in Hormone-Refractory Metastatic Breast Cancer

Status Completed

Clinical Trial Summary

This phase II trial studies how well everolimus with or without trastuzumab works in treating patients with breast cancer that has not responded to hormone therapy and has spread from where it started to other places in the body. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and adding trastuzumab at the time of disease progression may be an effective treatment for breast cancer.

Clinical Trial Description

Breast cancer is the most common type of invasive cancer in women, with more than 1 million cases and almost 600,000 deaths occurring worldwide annually. Breast cancer that has spread to other parts of the body (metastasized) is usually not curable. Patients with a type of metastatic breast cancer that has hormone receptors on the surface of the cancer cells are usually treated with the drug tamoxifen, which interferes with the function of these hormone receptors. However, the average survival time for these patients remains at around 36 months.

In patients who no longer respond to tamoxifen (hormone-refractory breast cancer), the cancer drug trastuzumab (Herceptin), which acts on a protein called human epidermal growth factor receptor 2 (HER2), may have some activity. In addition, studies suggest that the drug everolimus, which acts on a pathway within cancer cells that is important for growth of the tumor, may make the cancer cells more sensitive to treatment with trastuzumab. Thus, the two drugs may act together to increase their anti-cancer potential. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00912340
• Study type: Interventional
• Source: Emory University
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Completion date: July 2017