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Table 5 Ongoing clinical trials of extended aromatase inhibitor therapy

From: Status of adjuvant endocrine therapy for breast cancer

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
  1. 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.