Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075764
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2004-01-09
Brief Title:
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
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 HER2neu 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 4162009
Compare estradiol serum levels at 8 16 and 24 weeks in patients treated with these regimens closed as of 4162009
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
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 HER2neu 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 4162009
Compare estradiol serum levels at 8 16 and 24 weeks in patients treated with these regimens closed as of 4162009
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0226 | OTHER | None | None |
| CAN-NCIC-MAC7 | OTHER | NCIC-CTG | httpsreporternihgovquickSearchU10CA032102 |