Table 1 Summary of included studies.

From: Tailored duration of adjuvant trastuzumab for human epidermal growth factor receptor 2-positive breast cancer

Trial

Patient number

Trial design

Country or region

Median age (years)

Node negative

Hormone receptor positive

Adjuvant chemotherapya

Non-inferiority margin of HR

HR with 95% CI

Shortened time (month)

Endpoint

Median follow-up (year)

PHARE6

1691

Non-inferiority

France

55

55%

61%

A + T 73%; A 15%; T 11%

1.15

1.08 (0.93–1.25)

6

DFS

7.5

HORG7

481

Non-inferiority

Greece

55

21%

67%

Unspecified

1.53

1.57 (0.86–2.10)

6

DFS

3

Short-HER9

1254

Non-inferiority

Italy

55

54%

68%

A + T 100%

1.29

1.13 (0.85–1.49)b

9.9

DFS

6

SOLD8

2174

Non-inferiority

Finland

56

60%

66%

A + T 100%

1.3

1.39 (1.08–1.80)b

9.9

DFS

5.2

PERSEPHONE10

4088

Non-inferiority

UK

56

58%

69%

A + T 48%; A 42%; T 10%

1.29

1.07 (0.90–1.27)b

6

DFS

5.4

E219824

227

Superiority

USA

49

0

62%

Unspecified

NA

1.18 (0.56–2.44)

12

DFS

6.4

NCCTG N983112

1944

Superiority

USA

51

15%

54%

A + T 100%

NA

1.67 (1.47–1.89)

12

DFS

8.4

NSABP B-3112

2102

Superiority

USA

49

0

56%

A + T 100%

NA

1.67 (1.47–1.89)

12

DFS

8.4

HERA25

3401

Superiority

Global

49

32%

45%

A + T 26%; A 68%

NA

1.45 (1.27–1.69)c

12

DFS

8

BCIRG-00611

2147

Superiority

USA

48

29%

54%

A + T 100%

NA

1.39 (1.18–1.64)

12

DFS

10.3

PACS0426

528

Superiority

Europe

49

0

60%

A + T 47%; A 53%

NA

1.16 (0.82–1.64)

12

DFS

3.9

NOAH27

235

Superiority

Global

52

15%

36%

A + T 100%

NA

1.69 (1.11–2.63)

12

EFS

5.4

  1. CI confidence interval, DFS disease-free survival, EFS event-free survival, HR hazard ratio, NA not applicable.
  2. aA, Anthracycline-based; T, Taxane-based; A + T, anthracycline and taxane-containing.
  3. bCalculation of the 95% CI using the 90% CI provided in the original paper.
  4. cUsing the censored analysis in HERA trial. The censored analysis removed the crossover patients’ follow-up, which is a confounding factor, after the start of treatment with trastuzumab.