Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016432
Status:
COMPLETED
Last Update Posted:
2011-04-19
First Post:
2001-05-06
Brief Title:
Exemestane in Treating Postmenopausal Women With Resected Stage I Stage II or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Randomized Trial Evaluating The Effect Of Exemestane In Clinical Stage T1-3 N0-1 M0 Postmenopausal Breast Cancer Patients Completing At Least Five Years Of Tamoxifen Therapy
Status:
COMPLETED
Status Verified Date:
2011-04
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 exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer
PURPOSE Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I stage II or stage IIIA breast cancer and have completed 5 years of tamoxifen
PURPOSE Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I stage II or stage IIIA breast cancer and have completed 5 years of tamoxifen
Detailed Description:
OBJECTIVES
Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival overall survival and time to treatment failure in postmenopausal women with resected stage I II or IIIA breast cancer
Determine the effect of tamoxifen withdrawal on bone in terms of height fractures and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients
Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients
Evaluate the quality of life of a subset of these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral exemestane daily for 5 years
Arm II closed as of 101503 Patients receive an oral placebo daily for 5 years
Quality of life is assessed at baseline and then every 6 months for 55 years
Patients are followed every 6 months for 6 years and then annually thereafter
PROJECTED ACCRUAL A total of 3000 patients will be accrued for this study within 3 years and 4 months
Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival overall survival and time to treatment failure in postmenopausal women with resected stage I II or IIIA breast cancer
Determine the effect of tamoxifen withdrawal on bone in terms of height fractures and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients
Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients
Evaluate the quality of life of a subset of these patients
OUTLINE This is a randomized study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral exemestane daily for 5 years
Arm II closed as of 101503 Patients receive an oral placebo daily for 5 years
Quality of life is assessed at baseline and then every 6 months for 55 years
Patients are followed every 6 months for 6 years and then annually thereafter
PROJECTED ACCRUAL A total of 3000 patients will be accrued for this study within 3 years and 4 months
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 |
|---|---|---|---|
| CDR0000068640 | None | None | None |