Table 5.
Study | Number | Population (treatment received pre-enrollment) | Arms at random assignment | Study number |
---|---|---|---|---|
MA.17R |
1,918 |
Prior 4.5-6 years of AI, with or without prior Ta |
L (5 years) versus placebo (5 years) |
NCT00754845 |
Completed AI ≤2 years prior random assignment | ||||
SALSA |
3,486 |
Any endocrine therapy (5 years) |
A (5 years) versus A (2 years) |
NCT00295620 |
LEAD |
4,050 |
T (4-6 years) |
L (5 years) versus L (2-3 years) |
NCT01064635 |
DATA |
1,900 |
T (2-3 years) |
A (6 years) versus A (3 years) |
NCT00301457 |
NSABP-B42 |
3,966 |
AI or T→AIb (to 5 years) |
L (5 years) versus placebo (5 years) |
NCT00382070 |
SOLE | 4,800 | Any endocrine therapyc (5 years) | L (5 years) versus intermittentd L (5 years) | NCT00553410 |
aIncluding as part of MA.17. bTamoxifen must have been up to 3 years and may not have been given during years 4 and 5 of the 5 years of adjuvant hormonal therapy. cMust have completed 4 to 6 years of prior selective estrogen receptor modulators or aromatase inhibitors (AIs), or a sequential combination of both. When calculating 4 to 6 years, neoadjuvant endocrine therapy should not be included. dIntermittent: 48 months over 5 years: 4 × 9 months (9 months followed by 3-month treatment-free interval in years 1 to 4, at least 36 months) plus 1 × 12 months in years 5 at least 48 months. →, switch to; A, anastrozole; DATA, Different Durations of Anastrozole after Tamoxifen trial; L, letrozole; LEAD, Letrozole Adjuvant Therapy Duration trial; NSABP, National Surgical Adjuvant Breast and Bowel Project; SALSA, Secondary Adjuvant Long-term Study with Arimidex trial; SOLE, Study of Letrozole Extension trial; T, tamoxifen.