Initiation of Trial to Evaluate Abraxane™ In Addition to Herceptin® as Therapy

Initiation of Trial to Evaluate Abraxane™ In Addition to Herceptin® as Initial Therapy in Advanced Breast Cancer.

A clinical trial evaluating the treatment combination of Abraxane™ plus Herceptin® as initial therapy in women with HER2-positive breast cancer has recently been initiated and is currently enrolling patients.

Breast cancer is diagnosed in over 200,000 women annually in the United States alone. Metastatic breast cancer refers to cancer that has spread outside the breast, often to distant sites in the body. Standard treatment for metastatic breast cancer often includes chemotherapy, either in combination or as a single agent, with or without hormone therapy, radiation therapy, or targeted therapy. The exact treatment regimen for metastatic breast cancer is individualized for patients, as treatment is varied according to the extent of spread of the cancer, the site(s) to which the cancer has spread, characteristics of the cancer, and the ability of a patient to tolerate certain therapies. Treatment for metastatic breast cancer tends to be aimed at improving the duration of survival and/or quality of life for patients.

Abraxane™ is a new form of Taxol® that is bound with albumin, which is a type of protein normally found in the human body. This form of Taxol delivers high concentrations of the active ingredient into the cancer cells and reduces the incidence of side effects, compared to the original form of the drug. Many of the side effects of Taxol are caused by agents that are used for proper storage and administration of Taxol. Results from previous clinical trials evaluating Abraxane in patients with metastatic breast cancer have demonstrated that it improves anti-cancer response rates, time to cancer progression and overall survival compared to Taxol.[1],[2] In addition, patients tend to tolerate Abraxane better than Taxol. Abraxane was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with breast cancer who have stopped responding to prior therapies that included a class of commonly used chemotherapy agents referred to as anthracyclines (doxorubicin, epirubicin, Doxil®).[3] Clinical trials are ongoing to evaluate Abraxane in combination with other agents, as well as earlier in the course of the disease.

Some patients with breast cancer have what is called HER2-positive breast cancer. The HER2 pathway is associated with growth and replication of cancer cells. Some cancer cells overexpress HER2, and are referred to as HER2-positive. Herceptin® (trastuzumab) is a monoclonal antibody that is targeted against the human epidermal growth factor-2 (HER2) pathway. Herceptin binds to distinct components of HER2-positive cells and disrupts the replication of these cancer cells. The addition of Herceptin to chemotherapy has demonstrated improved outcomes, including survival, in patients with HER2-positive breast cancer. Herceptin is currently approved for treatment as a single agent in patients with HER2-positive metastatic breast cancer that has progressed or recurred following prior therapy, or in combination with the chemotherapy agent Taxol in patients with HER2-positive metastatic breast cancer who have not received prior therapy.

Researchers affiliated with the International Oncology Network (ION) are conducting a clinical trial to evaluate Abraxane as initial therapy in women with advanced breast cancer. This study is enrolling 70 patients from 20 different oncology sites. Patients with HER2-positive cancer will be treated with Herceptin in addition to Abraxane. Results from this trial will provide information that is necessary to move into final phases of clinical trials evaluating Abraxane as initial therapy for advanced breast cancer, as well as its treatment in combination with Herceptin in HER2-positive patients. Patients interested in participating in this clinical trial should speak with their physician regarding their individual risks and benefits of this treatment regimen.

The following is contact information for questions regarding this trial or enrollment for this trial:

American Pharmaceutical Partners, Inc.

Nicole Williams 847-969-2700

PondellWilkinson, Inc.

Rob Whetstone or Robert Jaffe 310-279-5963

References:

[1]Desai N, et al. ABI-007 (ABRAXANE), a nanoparticle albumin-bound (NAB) paclitaxel demonstrates superior efficacy vs Taxol in MBC: a phase III trial. Proceedings from the 2003 San Antonio Breast Cancer Symposium. San Antonio TX. 2003. Abstract #44.

[2]Perez E. New antitubulin agents. Proceedings from the 22nd Annual Miami Breast Cancer Conference. Miami FL. 2005.

[3]Abraxane Prescribing Information. Available at:

. Accessed June 2, 2005.

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