Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003678
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Tamoxifen in Treating Women With Breast Cancer
Sponsor:
University Hospital Birmingham
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Large Uniquely Simple Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2007-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed
PURPOSE Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed
Detailed Description:
OBJECTIVES
Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years
OUTLINE This is a randomized study Patients are stratified for analysis according to duration of tamoxifen given before randomization 2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over age less than 49 vs over 50 and important prognostic factors including tumor type and grade and nodal and estrogen receptor status Patients are randomized to 1 of 2 treatment arms
Arm I Patients discontinue tamoxifen after at least 2 years of prior treatment
Arm II Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression
Patients are followed annually
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 8000-20000 patients will be accrued for this study
Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years
OUTLINE This is a randomized study Patients are stratified for analysis according to duration of tamoxifen given before randomization 2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over age less than 49 vs over 50 and important prognostic factors including tumor type and grade and nodal and estrogen receptor status Patients are randomized to 1 of 2 treatment arms
Arm I Patients discontinue tamoxifen after at least 2 years of prior treatment
Arm II Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression
Patients are followed annually
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 8000-20000 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN17222211 | None | None | None |
| CRC-TU-ATTOM | None | None | None |
| EU-98042 | None | None | None |