Table 1 Demographic and clinical characteristics at baseline.

From: Subtyping-based platform guides precision medicine for heavily pretreated metastatic triple-negative breast cancer: The FUTURE phase II umbrella clinical trial

Characteristics

ITT (n = 141)

A (n = 4)

B (n = 20)

C (n = 46)

D (n = 10)

E (n = 46)

F (n = 6)

G (n = 9)

Age at enrollment, median (range), year

 

50 (23–74)

59.5 (54–65)

54 (33–74)

50.5 (29–71)

46 (29–56)

49 (28–66)

47 (34–58)

51 (23–65)

ECOG performance statusa, No. of patients (%)

      0

5 (3.5)

0

0

4 (8.7)

0

1 (2.2)

0

0

      1

120 (85.1)

4 (100.0)

19 (95.0)

39 (84.8)

8 (80.0)

38 (82.6)

4 (66.7)

8 (88.9)

      2

16 (11.3)

0

1 (5.0)

3 (6.5)

2 (20.0)

7 (15.2)

2 (33.3)

1 (11.1)

No. of previous therapies for metastatic disease, median (IQR)

 

3 (2–4)

4.5 (4–5)

3 (2–4)

3 (2–3)

3 (3–4)

3 (2–3)

2.5 (2–3)

3 (2–3)

Previous chemotherapy exposure, No. of patients (%)

      Taxane

140 (99.3)

4 (100.0)

20 (100.0)

46 (100.0)

9 (90.0)

46 (100.0)

6 (100.0)

9 (100.0)

      Anthracycline

131 (92.9)

4 (100.0)

18 (90.0)

44 (95.7)

9 (90.0)

44 (95.7)

5 (83.3)

7 (77.8)

      Platinum

132 (93.6)

4 (100.0)

19 (95.0)

40 (87.0)

10 (100.0)

44 (95.7)

6 (100.0)

9 (100.0)

      Gemcitabine

99 (70.2)

3 (75.0)

16 (80.0)

30 (65.2)

6 (60.0)

34 (73.9)

5 (83.3)

5 (55.6)

      Capecitabine

124 (87.9)

4 (100.0)

19 (95.0)

37 (80.4)

8 (80.0)

41 (89.1)

6 (100.0)

9 (100.0)

      Vinorelbine

114 (80.9)

3 (75.0)

16 (80.0)

35 (76.1)

9 (90.0)

39 (84.8)

6 (100.0)

6 (66.7)

No. of metastases, No. of patients (%)

      1

21 (14.9)

0

7 (35.0)

5 (10.9)

1 (10.0)

5 (10.9)

2 (33.3)

1 (11.1)

      2

49 (34.8)

2 (50.0)

4 (20.0)

19 (41.3)

2 (20.0)

16 (34.8)

2 (33.3)

4 (44.4)

      ≥ 3

71 (50.4)

2 (50.0)

9 (45.0)

22 (47.8)

7 (70.0)

25 (54.3)

2 (33.3)

4 (44.4)

Location of metastases, No. of patients (%)

      Lymph nodes

96 (68.1)

2 (50.0)

6 (30.0)

35 (76.1)

8 (80.0)

35 (76.1)

5 (83.3)

5 (55.6)

      Lung

69 (48.9)

2 (50.0)

8 (40.0)

19 (41.3)

5 (50.0)

29 (63.0)

2 (33.3)

4 (44.4)

      Liver

43 (30.5)

2 (50.0)

12 (60.0)

11 (23.9)

3 (30.0)

10 (21.7)

1 (16.7)

4 (44.4)

      Bone

69 (48.9)

3 (75.0)

8 (40.0)

21 (45.7)

5 (50.0)

25 (54.3)

3 (50.0)

4 (44.4)

      Chest wall

51 (36.2)

1 (25.0)

7 (35.0)

15 (32.6)

5 (50.0)

20 (43.5)

1 (16.7)

2 (22.2)

      Breast

32 (22.7)

1 (25.0)

4 (20.0)

12 (26.1)

4 (40.0)

7 (15.2)

1 (16.7)

3 (33.3)

      Others

30 (21.3)

0

5 (25.0)

11 (23.9)

4 (40.0)

8 (17.4)

2 (33.3)

0

Duration of first-line therapy, No. of patients (%)

      < 3 months

48 (34.0)

1 (25.0)

6 (30.0)

14 (30.4)

2 (20.0)

19 (41.3)

2 (33.3)

4 (44.4)

      3–6 months

42 (29.8)

2 (50.0)

6 (30.0)

13 (28.3)

4 (40.0)

16 (34.8)

1 (16.7)

0

      > 6 months

35 (24.8)

1 (25.0)

3 (15.0)

14 (30.4)

2 (20.0)

8 (17.4)

2 (33.3)

5 (55.6)

      Unknown

16 (11.3)

0

5 (25.0)

5 (10.9)

2 (20.0)

3 (6.5)

1 (16.7)

0

Disease-free intervalb, No. of patients (%)

      < 6 months

53 (37.6)

2 (50.0)

5 (25.0)

15 (32.6)

3 (30.0)

24 (52.2)

3 (50.0)

1 (11.1)

      6–12 months

17 (12.1)

1 (25.0)

5 (25.0)

5 (10.9)

0

5 (10.9)

1 (16.7)

0

      > 12 months

47 (33.3)

1 (25.0)

7 (35.0)

16 (34.8)

3 (30.0)

14 (30.4)

2 (33.3)

4 (44.4)

      Initially diagnosed as stage IV

24 (17.0)

0

3 (15.0)

10 (21.7)

4 (40.0)

3 (6.5)

0

4 (44.4)

  1. ITT Intention-to-treat, ECOG Eastern Cooperative Oncology Group, IQR interquartile range.
  2. aScores on the ECOG scale range from 0 (no disability) to 5 (death).
  3. bInterval between the time of metastasis or relapse and the last dose of adjuvant chemotherapy or surgery (for neoadjuvant chemotherapy cases without adjuvant chemotherapy).