Table 1: Adjuvant trastuzumab trials.

TrialsNEligible patientPathological tumor size in enrolled patientspN (UICC) in enrolled patientER (+) in enrolled patientsHG in enrolled patientsMedian follow-up, yearsDFS HR (95% CI,
𝑃 value)
OS HR (95% CI,
𝑃 value)
Reference

NCCTG N9831 and NSABP B-31Joint 3,969≤20 mm 39%
21–40 mm 45%
>40 mm 15%
pN0 53%
pN1 27%
pN3 14%
52%HG1, 2% HG2 28% HG3 69%2.90.49 (0.41–0.58, 𝑃 < 0 . 0 0 0 1 )0.63 (0.49–0.81, 𝑃 = 0 . 0 0 0 4 )[13]
NCCTG N9831 (control versus sequential HER) 2,184n (+) or n (−) and t > 1 cm for HR (−) and t > 2 cm for HR (+) NR NR  NR NR 5.50.67 (0.55–0.82, 𝑃 = 0 . 0 0 0 5 )0.86 (0.65–1.13, 𝑃 = 0 . 2 8 1 )[41]
NCCTG N9831 (concurrent HER versus sequential HER) 5.30.75 (0.60–0.94, 𝑃 = 0 . 0 1 9 0 )0.79 (0.59–1.08, 𝑃 = 0 . 1 3 5 )[41]

HERA5,081n (+) or n (−) and t > 1 cm≤20 mm 40%
21–50 mm 44%
>50 mm 5%
pN0 32%
pN1 29%
pN2 28%
46%HG1 3% HG2 32% HG3 60%20.76 (0.66–0.87, 𝑃 < 0 . 0 0 0 1 )0.85 (0.70–1.04, 𝑃 = 0 . 1 1 )[43]

BCIRG 006 (control versus DXT+HER) 3,222n (+) or n (−) and either t > 2 cm, HR (−), HG 2-3, or <35y.o ≤20 mm 40%
21–50 mm 54%
>50 mm 6%
pN0 29%
pN1 39%
pN3 33%
54% (ER and/or PgR) NR 5.40.64 (0.53–0.78, 𝑃 < 0 . 0 0 1 )0.63 (0.48–0.81, 𝑃 = 0 . 0 0 4 )[12]
BCIRG 006 (control versus TCH)0.75 (0.54–0.90, 𝑃 = 0 . 0 4 )0.77 (0.60–0.99, 𝑃 = 0 . 0 1 7 )[12]

FinHER232n (+) or n (−) and t ≥ 2 cm and PgR (−)≤10 mm 7%
1.1–20 mm 28%
>20 mm 65%
pN0 16%
pN1 53%
pN3 31%
47%HG1 2% HG2 31% HG3 65%30.42 (0.21–0.83, 𝑃 = 0 . 0 1 )0.41 (0.16–1.08, 𝑃 = 0 . 0 7 )[16]

PACS 04528n (+)≤20 mm 44%
>20 mm 54%
pN0 0%
pN1 58%
pN3 42%
60%HG1 3% HG2 31% HG3 65%3.90.86 (0.61–1.22, 𝑃 = 0 . 4 1 )1.27 (0.68–2.38, NR)[44]

HR: hazard ratio; 𝑛 (+): nodepositive; 𝑛 (−): nodenegative; NR: not reported; UICC: International Union Against Cancer.