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

Monotherapy (versus tamoxifen)

ATAC [42]

Double-blind

A versus T versus T + A (5 years)

9,366

HR⁺ EBC

DFS^a, occurrence of AEs

BIG 1-98 [43]

Double-blind

L versus T versus L→T versus T→L (5 years)

8,010

HR⁺ EBC

DFS^b

TEAM [44, 45]

Open-label, multinational

Upfront T versus E (2.75 years)

9,775

HR⁺ EBC

DFS^c

Sequential T→E versus E (5 years)

Sequential therapy

IES [46]

Double-blind

T→E versus T→T (5 years)

4,724

HR⁺ EBC

DFS^d

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

DFS^a

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

RFS^e

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

RFS^f

BIG 1-98 [43]

Double-blind

L versus T versus L→T versus T→L (5 years)

8,010

HR⁺ EBC

DFS^b

TEAM [44]

Open-label, multinational

Upfront E (2.75 years) versus T

9,779

HR⁺ EBC

DFS^c

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

DFS^g

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

RFS^h

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

DFS^a