Patient Accrual Completed in Clinical Trial Evaluating Abraxane™ in BreastCancer

Patient Accrual Completed in Clinical Trial Evaluating Abraxane™ in Early Breast Cancer

Researchers affiliated with U.S. Oncology, the nations leading healthcare services network, has announced that patient accrual for a clinical trial that is evaluating Abraxane in part of a chemotherapy regimen in early breast cancer has been completed. Results from this trial will help establish the potential role of Abraxane in the treatment of breast cancer.

Breast cancer is diagnosed in over 200,000 women annually in the United States alone. Early breast cancer refers to cancer that has not spread outside the breast. Standard treatment for early breast cancer often includes the surgical removal of the cancer followed by chemotherapy and radiation. Chemotherapy is used following surgery, referred to as adjuvant therapy, to kill any undetectable cancer cells that may be remaining in the body. Chemotherapy may be delivered in a dose-dense manner, which refers to administering therapy more frequently than conventional schedules. Studies have indicated that dose-dense chemotherapy following surgery in early breast cancer may improve long-term outcomes in these patients.[1] One commonly used dose-dense chemotherapy regimen consists of Adriamycin® (doxorubicin) and Cytoxan® (cyclophosphamide) followed by Taxol® (paclitaxel).

Abraxane is a new form of Taxol that is bound with albumin, 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. Results from clinical trials have demonstrated that Abraxane improves anti-cancer responses, time to cancer progression and overall survival compared to Taxol in advanced breast cancer.[2],[3] These results have prompted the initiation of further clinical trials to evaluate Abraxane in combination with other agents, as well as in different stages of breast cancer. 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®).

The current trial that is ongoing will evaluate the addition of Abraxane to Adriamycin® and Cytoxan® as adjuvant therapy in women with breast cancer. The chemotherapy regimen is being administered in a dose-dense manner. Results from this trial will provide information in preparation for a larger clinical trial evaluating dose-dense therapy with Abraxane with or without the targeted agent Herceptin® (trastuzumab) in early breast cancer. Results of this trial are eagerly awaited as the ultimate hope is that incorporation of Abraxane into therapeutic regimens in early stages of breast cancer will provide improved outcomes with fewer side effects for patients with this disease.

References:

[1]Citron ML, Berry DA, Cirrincione C, Hudis C, et al. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: First report of intergroup trial C9741/Cancer and Leukemia Group B trial 9741. Journal of Clinical Oncology. 2003; 21: 1-9.

[2]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.

[3]

Perez E. New antitubulin agents. Proceedings from the 22nd annual Miami Breast Cancer Conference. MiamiFL. 2005.

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