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Therapy for Postmenopausal Women with Metastatic Breast Cancer
Untitled Document
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.
Principal Investigators
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Dr. Rita S. Mehta
Principal Investigator |
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.
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.
Contact Information
See the list
of study contacts 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.
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