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
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Daniel Rea, MD
University Hospital Birmingham
United States: Federal Government