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Table 3 Study subject end of treatment objective response rates

From: Phase II trial of utidelone as monotherapy or in combination with capecitabine in heavily pretreated metastatic breast cancer patients

Utidelone starting dose, mg/m2

Best response,a n

ORR,b %

 

CR

PR

SD

PD

NA

Total

ORR

95 % CIc

Combination therapy: utidelone (30 mg/m2) and capecitabine (2000 mg/m2) n = 33

 25

0

2

1

0

0

3

66.7

9.4, 99.2

 30

1

11

10

2

1

25

48.0

27.8, 68.7

 35

0

0

4

1

0

5

0

Total

1

13

15

3

0

33

42.4

26.6, 60.9

Monotherapy: utidelone (40 mg/m2) n = 70

 40

1

19d

25

18

7

70

28.57

18.40, 40.62

  1. CR complete response, PR partial response, SD stable disease, PD progressive disease, ORR objective response rate, CI confidence interval
  2. aAssessed according to RECIST1.1
  3. bORR = (CR + PR)/total × 100 %
  4. cCalculated using Clopper Pearson method
  5. dIncluding 17 patients with PR and 2 patients with unconfirmed PR