Pfizer to present new Aromasin data and begin phase III Sutent trial

Results of two studies evaluating the hormonal therapy Aromasin (exemestane tablets) and the chemotherapy Ellence (epirubicin hydrochloride injection) were presented at the San Antonio Breast Cancer Symposium (SABCS) from December 14 to 17 2006.

The Aromasin B-33 study is evaluating postmenopausal women with hormone receptor-positive breast cancer who, after five years of tamoxifen therapy, received either Aromasin or placebo. The Ellence Interim Analysis of Women with High Risk Node Negative Breast Cancer compared the efficacy of several common chemotherapy regimens, including Ellence, cyclophosphamide, flurorouracil (CEF), Ellence and cyclophosphamide followed by paclitaxel (ECT) and a combination of doxorubicin and cyclophosphamide followed by paclitaxel (AC/T).

The phase III Sutent trial is a randomised open-label study of sunitinib in combination with paclitaxel versus bevacizumab with paclitaxel as a first-line treatment for patients with advanced breast cancer. It is now open and enrolling more than 700 patients at 20 sites across the US and the initiation of a second phase III trial is expected in early 2007.

A phase II randomised, open-label study of sunitinib versus standard-of-care for patients with previously treated advanced triple receptor negative (ER-, PR- and HER2-) breast cancer is currently enrolling patients at 44 international sites, including more than 25 US ones.

Dr Charles Baum, vice-president of Pfizer Global Research and Development and oncology clinical leader, said: ìNew data are showing that Aromasin and Ellence can improve the outcomes for women with breast cancer. Looking forward, we are pleased to begin studying patients with Sutent in combination with a taxane in a phase III trial for the first-line treatment of advanced breast cancer.î