Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
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.
Drug: tamoxifen citrate
Procedure: adjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study|
- Overall survival (i.e., all-cause mortality) [ Designated as safety issue: No ]
- Specific-cause mortality [ Designated as safety issue: No ]
- Incidence of second primary tumors [ Designated as safety issue: No ]
|Study Start Date:||October 1995|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003016
|Atlas Trial Office|
|Oxford, England, United Kingdom, OX2 6HE|
|Study Chair:||Rodrigo Arriagada, MD||Karolinska Institutet|