Table 2 Association between TIMP-1 status and patient demographics, disease characteristics, and prior therapy

No. of patients

54

210

Regimen

0.36

  Docetaxel and Gemcitabine

25

(46.3)

112

(53.3)

  Docetaxel

29

(53.7)

98

(46.7)

Median age at randomization, years

60

59

0.79^e

  Range

37-74

30-75

ECOG performance status

0.91

  0-1

47

(87.0)

176

(83.8)

  2

6

(11.1)

26

(12.4)

  Unknown

1

(1.9)

8

(3.8)

Stage of disease

0.58

  Locally advanced

3

(5.6)

19

(9.0)

  Metastatic

51

(94.4)

191

(91.0)

No. of metastatic sites

0.40

  1

12

(22.2)

66

(31.4)

  2

22

(40.7)

71

(33.8)

  ≥ 3

20

(37.0)

73

(34.8)

Type of metastatic site

  Visceral

31

(57.4)

119

(56.7)

1.00

  Lung

17

(31.5)

61

(29.0)

0.87

  Liver

18

(33.3)

81

(38.6)

0.44

  Non-visceral

23

(42.6)

91

(43.3)

  Bone

33

(61.1)

142

(67.6)

0.42

Hormone receptor status

0.30

  Positive

42

(77.8)

148

(70.5)

  Negative

11

(20.4)

59

(28.1)

  Unknown

1

(1.9)

3

(1.4)

HER2 status^a

0.66

  Normal/deletion

40

(74.1)

172

(81.9)

  Amplification

8

(14.8)

29

(13.8)

  Unknown

6

(11.1)

9

(4.3)

PAM50 subtype

0.89

  Luminal A

15

(27.8)

63

(30.0)

  Luminal B

20

(37.0)

74

(35.2)

  Basal-like

7

(13.0)

33

(15.7)

  HER2-enriched

11

(20.4)

35

(16.7)

  Unknown

1

(1.9)

5

(2.4)

Prior chemotherapy

  Total

37

(68.5)

151

(71.9)

0.62

  (Neo)adjuvant

23

(42.6)

104

(49.5)

0.45

   Anthracycline

14

(25.9)

57

(27.1)

   Non-anthracycline

9

(16.7)

47

(22.4)

  Locally advanced/metastatic

21

(38.9)

81

(38.6)

1.00

   Anthracycline

15

(27.8)

71

(33.8)

   Non-anthracycline

6

(11.1)

10

(4.8)

Hormonal therapy

  Total

36

(66.7)

137

(65.2)

0.87

  Adjuvant

24

(44.4)

95

(45.2)

1.00

  Locally advanced/metastatic

27

(50.0)

93

(44.3)

0.54

Radiation therapy

33

(61.1)

124

(59.0)

0.88

Disease-free interval, months^b

  Median

36

31

0.41^e

  Range

0-224

0-250