Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.
PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 4 years.
PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer meeting 1 of the following criteria:
Measurable or nonmeasurable disease
No known brain or CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Postmenopausal, as defined by 1 of the following:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Prior adjuvant hormonal therapy allowed
At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues
More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane)
More than 12 months since prior fulvestrant
No prior hormonal therapy for recurrent or metastatic disease
No other concurrent hormonal therapy for malignancy
No concurrent hormone replacement therapy
Radiotherapy
Surgery
Other
Tucson, Arizona 85724-5024, United States
Fort Smith, Arkansas 72903, United States
Loma Linda, California 92354, United States
Los Angeles, California 90089-9181, United States
Marysville, California 95901, United States
Aurora, Colorado 80045, United States
Boca Raton, Florida 33486, United States
Pensacola, Florida 32514, United States
Savannah, Georgia 31405, United States
Boise, Idaho 83706, United States
Boise, Idaho 83712, United States
Maywood, Illinois 60153, United States
Ottawa, Illinois 61350, United States
Peoria, Illinois 61615, United States
La Porte, Indiana 46350, United States
Wichita, Kansas 67214, United States
Lewiston, Maine 04240, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Cape Girardeau, Missouri 63701, United States
St Louis, Missouri 63110, United States
Billings, Montana 59101, United States
Missoula, Montana 59807, United States
Concord, New Hampshire 03301, United States
Morristown, New Jersey 07962, United States
New Brunswick, New Jersey 08903, United States
Albuquerque, New Mexico 87110, United States
Santa Fe, New Mexico 87505, United States
Cooperstown, New York 13326, United States
Poughkeepsie, New York 12601-3990, United States
Rochester, New York 14642, United States
Pinehurst, North Carolina 28374, United States
Wilmington, North Carolina 28401, United States
Portland, Oregon 97213-2967, United States
Portland, Oregon 97227, United States
Drexel Hill, Pennsylvania 19026, United States
DuBois, Pennsylvania 15801, United States
Scranton, Pennsylvania 18510, United States
Orangeburg, South Carolina 29118, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195-6043, United States
Yakima, Washington 98902, United States
Huntington, West Virginia 25701, United States
Parkersburg, West Virginia 26102, United States
Eau Claire, Wisconsin 54701, United States
Elkhorn, Wisconsin 53121, United States
Green Bay, Wisconsin 54301-3526, United States