Tamoxifen in Treating Women With Breast Cancer
|ClinicalTrials.gov Identifier: NCT00003678|
Recruitment Status : Unknown
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: tamoxifen citrate Procedure: adjuvant therapy||Phase 3|
- 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 8,000-20,000 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20000 participants|
|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|
|Study Start Date :||May 1991|
- All-cause mortality
- Disease recurrence
- Death due to breast cancer, other primary tumors, or cardiovascular causes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003678
|Cancer Research UK Clinical Trials Unit - Birmingham|
|Birmingham, England, United Kingdom, B15 2TT|
|Study Chair:||Daniel Rea, MD||University Hospital Birmingham|