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news.American Pharmaceutical Partners and American BioScience have provided an update on their Abraxane development program, revealing that patient accrual has been completed in an initial phase II study of dose dense Abraxane in breast cancer.
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The study is evaluating Abraxane administered as adjuvant therapy following Adriamycin (A) plus Cytoxan (C) in early stage breast cancer. Adjuvant treatment is given after primary therapy (often surgery) to kill any microscopic deposits of cancer cells that may have spread.
Studies have shown that adjuvant therapy of AC followed by paclitaxel for breast cancer increases the chance of long-term survival by preventing recurrence and that giving treatment every two weeks (i.e., dose dense) versus every three weeks also may be beneficial.
This open-label initial phase II study is being conducted by US Oncology (USO), with a primary goal of evaluating the safety of Adriamycin plus Cytoxan administered every two weeks for four cycles, the most commonly used regimen in the adjuvant treatment of breast cancer, followed by 260mg/m2 of Abraxane administered in a dose dense regimen, every two weeks for four cycles.
In light of recent findings, which demonstrated that Roche and Genentech’s Herceptin plus chemotherapy (combination of AC followed by paclitaxel) improved disease-free survival and overall survival in the adjuvant setting, combination therapy of AC with Abraxane, in addition to a dose dense regimen, as well as the inclusion of Herceptin for HER2-positive patients, forms the basis for a pivotal phase III study in the adjuvant setting to examine the important role Abraxane may play.