Skip to main content

Table 1 Main prospective, randomized, phase III clinical trials testing adjuvant aromatase inhibitors

From: Status of adjuvant endocrine therapy for breast cancer

Study Design Arms Number Population (post-menopausal women) Primary endpoint (s)
Monotherapy (versus tamoxifen)
ATAC [42] Double-blind A versus T versus T + A (5 years) 9,366 HR+ EBC DFSa, occurrence of AEs
BIG 1-98 [43] Double-blind L versus T versus L→T versus T→L (5 years) 8,010 HR+ EBC DFSb
TEAM [44, 45] Open-label, multinational Upfront T versus E (2.75 years) 9,775 HR+ EBC DFSc
   Sequential T→E versus E (5 years)    
Sequential therapy
IES [46] Double-blind T→E versus T→T (5 years) 4,724 HR+ EBC DFSd
ARNO 95 [47] Open-label T (2 years) → earsabears) versus T (2 years) → T (3 years) 979 HR+ EBC who received 2 years of T DFSa
ABCSG Trial 8 [48] Open-label T (5 years) versus T (2 years)→A (3 years) 3,714 HR+ EBC who received 2-3 years of T RFSe
ITA [49] Open-label, multi-center T (2-3 years)→A (5 years) versus T (5 years) 448 HR+ (or unknown) node+ EBC who received 2-3 years of T RFSf
BIG 1-98 [43] Double-blind L versus T versus L→T versus T→L (5 years) 8,010 HR+ EBC DFSb
TEAM [44] Open-label, multinational Upfront E (2.75 years) versus T 9,779 HR+ EBC DFSc
   E (5 years) versus sequential T→E    
Extended therapy
MA.17 [50] Double-blind L versus placebo 5,187 HR+ EBC who had received 4.5 to 6 years of adjuvant T therapy DFSg
ABCSG Trial 6a [51] Open-label A (3 years) versus no further treatment 856 HR+ EBC who had received 5 years of adjuvant T, with or without AG, for the first 2 years of therapy RFSh
NSABP-33 [52] Double-blind E (5 years) versus placebo (5 years) 1,598 HR+ T1-3N1M0 EBC who were disease-free after 5 years of adjuvant T DFSa
  1. aTime from random assignment to the occurrence of local or distant recurrence, new contralateral breast cancer, or death from any cause; btime from random assignment to the first of the following events: invasive recurrence in local, regional, or distant sites; a new invasive cancer in the contralateral breast; any second (non-breast) primary cancer; or death without a previous cancer event; ctimes from random assignment to the earliest documentation of disease relapse (locoregional or distant tumor recurrence or ipsilateral or contralateral breast cancer) or death from any cause; dtime from random assignment to local or distant breast cancer recurrence, new primary breast cancer, or death without recurrence (intercurrent death); etime from random assignment to the earliest occurrence of local or distant recurrence or death as a result of any cause; ftime from random assignment to disease recurrence, including both locoregional and distant recurrences (except contralateral breast cancer); gtime from random assignment to the recurrence of the primary disease (in the breast, chest wall, or nodal or metastatic sites) or the development of a new primary breast cancer in the contralateral breast; hinterval between the start of treatment or of the observation period and the first evidence of locoregional recurrence, contralateral breast cancer, or distant metastasis. →, switch to; A, anastrozole; ABCSG, Austrian Breast and Colorectal Cancer Study Group; AE, adverse event; AG, aminoglutethimide; ARNO 95, Arimidex-Nolvadex 95; ATAC, Arimidex, Tamoxifen, Alone or in Combination; BIG, Breast International Group; DFS, disease-free survival; E, exemestane; EBC, early breast cancer; HR, hormone receptor; IES, Intergroup Exemestane Study; ITA, Italian Tamoxifen Anastrozole (trial); L, letrozole; NSABP, National Surgical Adjuvant Breast and Bowel Project; RFS, recurrence-free survival; T, tamoxifen; TEAM, Tamoxifen Exemestane Adjuvant Multinational.