S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer|
- Time to tumor progression [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Clinical response rates [ Time Frame: 13 months ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||October 2013|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I
Patients receive oral anastrozole once daily on days 1-28.
Experimental: Arm II
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
Given orallyDrug: fulvestrant
- Compare the time to tumor progression in postmenopausal women with metastatic breast cancer treated with anastrozole with or without fulvestrant as first-line therapy.
- Compare the clinical benefit (complete or partial response, confirmed or unconfirmed, or stable disease ≥ 24 weeks) and overall survival of patients treated with these regimens.
- Compare adverse events in patients treated with these regimens.
- Determine the prognostic significance of estrogen receptor positivity and HER2/neu status in patients treated with these regimens.
- Determine parameters of estrogen and clinical pharmacology and estrogen levels in patients treated with these regimens.
- Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009).
- Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009).
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.
- Arm I: Patients receive oral anastrozole once daily on days 1-28.
- Arm II: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
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.
Show 426 Study Locations
|Study Chair:||Rita S. Mehta, MD||Chao Family Comprehensive Cancer Center|
|Study Chair:||Theodore A. Vandenberg, MD||London Regional Cancer Program at London Health Sciences Centre|