AstraZeneca announced that patient recruitment has begun on an important new clinical trial that will assess the efficacy and tolerability of Faslodex (fulvestrant) Injection vs. exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer. The trial, called EFECT (Evaluation of Faslodex vs. Exemestane Clinical Trial), is designed to evaluate the effectiveness of Faslodex in patients with advanced breast cancer whose disease has recurred or progressed on treatment with a nonsteroidal aromatase inhibitor (NSAI). The study will enroll 660 women from 100 to 150 centers in the United States and throughout the world.

EFECT is a randomized, double-blinded phase III trial. Participants in the trial will be randomly assigned to receive 250 mg injection of Faslodex administered every 28 days (an initial 500 mg injection on day zero followed by 250 mg injection on days 14 and 28, and once monthly thereafter) or 25 mg of exemestane (a steroidal aromatase inhibitor) administered once daily as a tablet. Trial participants must be postmenopausal women receiving treatment with a NSAI for locally advanced or metastatic breast cancer whose disease has progressed, or whose disease has recurred within six months of discontinuing NSAI therapy.

"This trial represents the first time that Faslodex will be studied in patients who have experienced disease progression or recurrence on a nonsteroidal aromatase inhibitor," said William Gradishar, EFECT International Coordinating Investigator, and Associate Professor of Medicine and Director of Breast Medical Oncology, Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Ill. "Previous trials in this patient population have been in post-tamoxifen failures. EFECT is an important trial that will help us better understand the sequencing options available for patients with hormone receptor-positive metastatic breast cancer."

"The EFECT trial is another step in AstraZeneca's ongoing commitment to breast cancer. We believe it is essential that we continue to explore new treatment options for women with breast cancer," said Gerard Kennealey, Vice President, Oncology Clinical Research, AstraZeneca. Faslodex is currently approved in the United States for treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy such as tamoxifen. It is an estrogen receptor antagonist without known agonist effects, and the only antiestrogen to be proven effective after tamoxifen failure. Faslodex works by finding estrogen receptors in the cancer cells and binding to them. In doing so, it keeps estrogen from binding to them. The binding of Faslodex also causes the receptors to change shape and become less functional. In clinical studies of postmenopausal women with breast cancer, treatment with Faslodex showed a decrease (downregulation) in the amount of estrogen receptors in breast cancer cells.