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Table 2 Baseline patient demographic and disease characteristics (FAS)

From: Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study

 

gBRCAm status

 

Positive (N = 33)

Negative (N = 308)

FAS (N = 341)

Age at enrollment (years)

n

33

308

341

 Median (range)

47.0 (25–71)

56.5 (29–89)

56.0 (25–89)

Race, n (%)

n

28

267

295

 White

22 (78.6)

201 (75.3)

223 (75.6)

 Black or African American

0

4 (1.5)

4 (1.4)

 Asian

6 (21.4)

60 (22.5)

66 (22.4)

 Native Hawaiian or Other Pacific Islander

0

1 (0.4)

1 (0.3)

 Other

0

1 (0.4)

1 (0.3)

Age at initial breast cancer diagnosis (years)

n

31

307

338

 Median (range)

40.0 (24–71)

52.0 (24–86)

50.0 (24–86)

Family history of breast and/or ovarian cancer, n (%)

n

33

307

340

 Yes

15 (45.5)

51 (16.6)

66 (19.4)

 No

18 (54.5)

256 (83.4)

274 (80.6)

Time since initial breast cancer diagnosis to enrollment (months)

n

31

307

338

 Median (interquartile range)

28.1 (13.4–73.0)

29.9 (6.3–78.2)

29.8 (7.2–76.8)

Sites of metastatic disease, n (%)

n

33

308

341

 Bone and locomotor

13 (39.4)

162 (52.6)

175 (51.3)

 Lymph nodes

15 (45.5)

134 (43.5)

149 (43.7)

 Respiratory

10 (30.3)

86 (27.9)

96 (28.2)

 Liver

8 (24.2)

69 (22.4)

77 (22.6)

 Other metastatic sites

23 (69.7)

194 (63.0)

217 (63.6)

HR status at most recent assessment, n (%)

n

31

303

334

 Positive

20 (64.5)

195 (64.4)

215 (64.4)

AJCC stage at initial breast cancer diagnosis, n (%)

n

33

303

336

 0

1 (3.0)

8 (2.6)

9 (2.7)

 Stage I (I, A, B, C)

3 (9.1)

28 (9.2)

31 (9.2)

 Stage II (II, A, B, C)

13 (39.4)

104 (34.3)

117 (34.8)

 Stage III (III, A, B, C)

8 (24.2)

80 (26.4)

88 (26.2)

 Stage IV (IV, A, B, C)

8 (24.2)

83 (27.4)

91 (27.1)

Nodal status at original diagnosis, n (%)

n

33

307

340

 N0

12 (36.4)

74 (24.1)

86 (25.3)

 N1

8 (24.2)

106 (34.5)

114 (33.5)

 N2

7 (21.2)

54 (17.5)

61 (17.9)

 N3

5 (15.2)

38 (12.4)

43 (12.6)

 pN0

0

4 (1.3)

4 (1.2)

 NX

1 (3.0)

29 (9.4)

30 (8.8)

 N1a

0

2 (0.7)

2 (0.6)

Tumor grade at original diagnosis, n (%)

n

33

303

336

 X (undetermined)

3 (9.1)

65 (21.5)

68 (20.2)

 1 (well differentiated)

2 (6.1)

22 (7.3)

24 (7.1)

 2 (moderately differentiated)

10 (30.3)

101 (33.3)

111 (33.0)

 3 (poorly differentiated)

15 (45.5)

103 (34.0)

118 (35.1)

 4 (undifferentiated)

0

3 (1.0)

3 (0.9)

 High grade*

3 (9.1)

9 (3.0)

12 (3.6)

Non-chemotherapy treatment prior to metastatic disease, n (%)

n

33

305

338

 Tamoxifen

7 (21.2)

74 (24.3)

81 (24.0)

 Letrozole

3 (9.1)

37 (12.1)

40 (11.8)

 Anastrozole

2 (6.1)

35 (11.5)

37 (10.9)

 Exemestane

1 (3.0)

3 (1.0)

4 (1.2)

 Fulvestrant

0

8 (2.6)

8 (2.4)

 Everolimus

1 (3.0)

0

1 (0.3)

 Other

1 (3.0)

11 (3.6)

12 (3.6)

  1. AJCC American Joint Committee on Cancer, BRCA breast cancer susceptibility gene, eCRF electronic case report form, FAS full analysis set, gBRCA germline BRCA mutation, HR hormone receptor, SD standard deviation
  2. *High grade was listed as an additional category in the eCRF and is based on the Nottingham grading system (total score: 8–9)
  3. A patient may have had more than one type of non-chemotherapy treatment
  4. Additional non-chemotherapy treatments to those listed in the table included leuprorelin/leuprorelin acetate (n = 5), toremifene/toremifene citrate (n = 3), bevacizumab (n = 1), goserelin (n = 1), tamoxifen citrate (n = 1), and trastuzumab (n = 1)