Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
|ClinicalTrials.gov Identifier: NCT00003016|
Recruitment Status : Unknown
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: tamoxifen citrate Procedure: adjuvant therapy||Phase 3|
- Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.
OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
Patients are followed annually.
PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20000 participants|
|Official Title:||Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study|
|Study Start Date :||October 1995|
- Overall survival (i.e., all-cause mortality)
- Specific-cause mortality
- Incidence of second primary tumors
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003016
|Atlas Trial Office|
|Oxford, England, United Kingdom, OX2 6HE|
|Study Chair:||Rodrigo Arriagada, MD||Karolinska Institutet|