A Phase III Study Comparing Anastrozole, Letrozole and Exemestane, Upfront (for 5 Years) or Sequentially (for 3 Years After 2 Years of Tamoxifen), as Adjuvant Treatment of Postmenopausal Patients With Endocrine-responsive Breast Cancer
- To compare sequential tamoxifen for 2 years followed by anastrozole, letrozole, or
exemestane for 3 years vs anastrozole, letrozole, or exemestane for 5 years in terms of
disease-free survival in postmenopausal women with nonrecurrent, nonmetastatic invasive
endocrine-responsive breast cancer.
- To compare disease-free survival in patients treated with anastrozole vs letrozole vs
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor
status (estrogen receptor [ER]-positive and progesterone [PgR] receptor-positive disease vs
ER-positive and PgR-negative disease vs ER-negative and PgR-positive disease vs ER- or
PgR-positive disease or ER or PgR status unknown), HER-2/neu status (positive [3+ by IHC or
positive by fluorescence in situ hybridization ( FISH)] vs negative vs unknown), prior
chemotherapy (none vs adjuvant vs neoadjuvant vs both adjuvant and neoadjuvant), and nodal
status (pN0 vs pN1 vs pN2 vs pN3). Patients are randomized to 1 of 6 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 5 years.
- Arm II: Patients receive oral exemestane once daily for 5 years.
- Arm III: Patients receive oral letrozole once daily for 5 years.
- Arm IV: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral
anastrazole once daily for 3 years.
- Arm V: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral
exemestane once daily for 3 years.
- Arm VI: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral
letrozole once daily for 3 years.
Treatment in all arms continues in the absence of disease recurrence or unacceptable
After completion of study therapy, patients are followed periodically.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Sabino De Placido, MD
Federico II University