Name of the Trial
Phase III Randomized Study of Anastrozole with or without Fulvestrant as First-Line Therapy in Postmenopausal Women with Metastatic Breast Cancer (SWOG-S0226). See the protocol summary at http://cancer.gov/clinicaltrials/SWOG-S0226.

Principal Investigators
Dr. Rita S. Mehta, Southwest Oncology Group, and Dr. Theodore Vandenberg, National Cancer Institute of Canada.

Why Is This Trial Important?
In women with breast cancer, cancer cell growth may be promoted by estrogen (referred to as hormone-sensitive disease). Postmenopausal women whose tumors are hormone sensitive often take an antiestrogen drug following initial treatment of their cancer. The most common antiestrogen drug used is tamoxifen, which blocks the binding of estrogen to its receptors inside cells. Recent studies, however, indicate that another drug, anastrozole, is more effective than tamoxifen and has fewer side effects. Anastrozole reduces estrogen levels in the body by inhibiting production of the hormone, thereby suppressing hormone-sensitive tumor growth. If breast cancer progresses while a patient is on hormonal therapy, fulvestrant, a drug that lowers estrogen receptor levels, may be given.

In this phase III trial, researchers are comparing the effectiveness of anastrozole alone or in combination with fulvestrant as first-line therapy in treating postmenopausal women who have hormone-sensitive, metastatic breast cancer.

"This study will show us whether there is an added benefit to combining fulvestrant with anastrozole as a first-line therapy," said Dr. Mehta. "Furthermore, this type of regimen may ultimately serve as a treatment for earlier breast cancer."

Who Can Join This Trial?
Researchers seek to enroll 690 postmenopausal women with advanced metastatic breast cancer and whose tumors are hormone sensitive. See the full list of eligibility criteria for this trial at http://cancer.gov/clinicaltrials/SWOG-S0226.

Where Is This Trial Taking Place?
Multiple study sites in the United States and Canada are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/SWOG-S0226.

Contact Information
See the list of study contacts at http://cancer.gov/clinicaltrials/SWOG-S0226 or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.


An archive of "Featured Clinical Trial" columns is available at
http://cancer.gov/clinicaltrials/ft-all-featured-trials.