Table 1.
Summary of the NSABP breast cancer adjuvant systemic therapy clinical trials
| Trial | Trial period* | Treatment | No. of patients† | Receptor status | Nodal status | No. of events‡ | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| OS | DFS | R | LRR | DR | ||||||
| B-05 | 1972–1996 | P vs placebo | 348 | Not recorded | + | 256 | 276 | 214 | 76 | 136 |
| B-07 | 1975–1996 | PF vs P | 671 | Not recorded | + | 446 | 517 | 392 | 130 | 262 |
| B-08 | 1976–1996 | PMF vs PF | 686 | Not recorded | + | 444 | 506 | 404 | 131 | 266 |
| B-09 | 1977–2004 | PF+TAM vs PF | 1545 | ER±/PR± | + | 1090 | 1222 | 949 | 324 | 616 |
| B-10 | 1977–1996 | PF+CP vs PF | 254 | Not recorded | + | 154 | 181 | 159 | 54 | 105 |
| B-11 | 1981–1996 | PAF vs PF | 683 | ER- and /or PR- | + | 378 | 441 | 371 | 162 | 209 |
| B-12 | 1981–2004 | PAF+TAM vs PF+TAM | 1073 | ER+ | + | 667 | 762 | 511 | 134 | 373 |
| B-13 | 1981–2004 | Surgery vs surgery + M→F | 731 | ER- | – | 240 | 351 | 204 | 80 | 116 |
| B-14 | 1982–2007 | Placebo vs TAM | 2817 | ER+ | – | 1187 | 1652 | 796 | 312 | 477 |
| B-15 | 1984–2004 | AC vs AC+CMF(x3) vs CMF | 2295 | ER±/PR± | + | 1182 | 1461 | 1208 | 425 | 761 |
| B-16 | 1984–2004 | AC+TAM vs TAM§ | 833 | ER±/PR± | + | 467 | 568 | 382 | 117 | 260 |
| B-19 | 1988–2006 | M→F vs CMF | 1074 | ER- | – | 266 | 428 | 228 | 96 | 132 |
| B-20 | 1988–2006 | TAM vs M→F+TAM vs CMF+TAM | 2299 | ER+ | – | 439 | 774 | 380 | 148 | 231 |
| B-22 | 1989–2006 | AC vs AC(i) vs AC(ii) | 2255 | ER±/PR± | + | 1053 | 1367 | 1048 | 364 | 681 |
| B-23 | 1991–2006 | AC±TAM vs CMF±TAM | 1952 | ER- | – | 335 | 545 | 316 | 126 | 186 |
| B-25 | 1992–2006 | AC(ii) vs AC(ii-i) vs AC(ii-ii) | 1977 | ER±/PR± | + | 794 | 1069 | 854 | 294 | 558 |
| B-28 | 1995–2009 | AC vs AC→T1 | 3036 | ER±/PR± | + | 862 | 1266 | 919 | 288 | 626 |
| B-30 | 1999–2012 | AC→T2 vs AT2 vs AT2C | 5240 | ER±/PR± | + | 1169 | 1769 | 1218 | 262 | 948 |
| B-31 | 2000-open | AC→T1 vs AC→T1+H | 2050 | ER±/PR±; HER2+ | + | 395 | 642 | 487 | 120 | 367 |
* Trial period: year opened to accrual – year closed to follow-up. A = adriamycin; C = cyclophosphamide; CP = corynebacterium parvum; DFS = disease-free survival; DR = distant recurrence; ER = estrogen receptor; F = 5-fluorouracil; H = herceptin; i = intensified; ii = intensified and increased; LRR = local-regional recurrence; M = methotrexate; OS = overall survival; P = L-Phenylalanine mustard; PR = progesterone receptor; R = recurrence; TAM = tamoxifen; T1 = taxol; T2 = taxotere.
† Eligible with follow-up and known receptor status.
‡ The location for some of the recurrences was unknown, and could not be classified as either LRR or DR.
§ B-16 is a three-arm trial, the primary comparison relates to these two regimens.