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Table 2 Safety overview (safety population, regardless of causality)

From: A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer

 

Part 1: pictilisib + paclitaxel ± bevacizumaba

Part 2A: pictilisib + paclitaxel

Part 2B: pictilisib + paclitaxel + bevacizumab

Part 2C: pictilisib + paclitaxel + trastuzumab

Part 3: pictilisib + letrozole

All patients

(N = 69)

Pictilisib dose

n (%)

60 mg

(n = 13)

100 mg

(n = 7)

165 mg

(n = 3)

250 mg

(n = 9)

330 mg

(n = 6)

200 mg

(n = 6)

250 mg

(n = 6)

260 mg

(n = 3)

180 mg

(n = 3)

260 mg

(n = 6)

260 mg

(n = 7)

All-grade AEs

13 (100)

7 (100)

3 (100)

9 (100)

6 (100)

6 (100)

6 (100)

3 (100)

3 (100)

6 (100)

7 (100)

69 (100)

Grades 3–4 AEs

8 (61.5)

7 (100)

3 (100)

7 (77.8)

5 (83.3)

3 (50.0)

5 (83.3)

3 (100)

1 (33.3)

3 (50.0)

3 (42.9)

48 (69.6)

Grade 5 AEs

1 (7.7)b

0

0

0

0

0

0

0

0

0

1 (14.3)c

2 (2.9)

SAEs

3 (23.1)

1 (14.3)

1 (33.3)

5 (55.6)

5 (83.3)

2 (33.3)

0

0

0

1 (16.7)

3 (42.9)

21 (30.4)

DLTs

1 (7.7)

0

0

1 (11.1)

2 (33.3)

0

1 (16.7)

0

0

1 (16.7)

0

6 (8.7)

Study withdrawal due to AE

3 (23.1)

2 (28.6)

0

1 (11.1)

2 (33.3)

0

1 (16.7)

2 (66.7)

0

2 (33.3)

2 (28.6)

15 (21.7)

Pictilisib withdrawal due to AE

4 (30.8)

2 (28.6)

1 (33.3)

1 (11.1)

2 (33.3)

0

1 (16.7)

3 (100)

0

2 (33.3)

2 (28.6)

18 (26.1)

            

n = 62

Paclitaxel withdrawal due to AE

6 (46.2)

3 (42.9)

2 (66.7)

1 (11.1)

2 (33.3)

0

1 (16.7)

2 (66.7)

1 (33.3)

3 (50.0)

–

21 (33.9)

            

n = 35

Bevacizumab withdrawal due to AE

6 (46.2)

3 (42.9)

–

–

–

2 (33.3)

1 (16.7)

2 (66.7)

–

–

–

14 (40.0)

            

(n = 9)

Trastuzumab withdrawal due to AE

–

–

–

–

–

–

–

–

0

0 2 (33.3)

–

2 (22.2)

Letrozole withdrawal due to AE

–

–

–

–

–

–

–

–

–

–

2 (28.6)

–

Pictilisib dose reduction due to AE

0

0

0

1 (11.1)

1 (16.7)

0

3 (50.0)

1 (33.3)

0

0

0

6 (8.7)

Pictilisib dose interruption due to AE

7 (53.8)

3 (42.9)

2 (66.7)

5 (55.6)

4 (66.7)

4 (66.7)

3 (50.0)

3 (100)

0

4 (66.7)

4 (57.4)

39 (56.5)

  1. Abbreviations: AE Adverse event, DLT Dose-limiting toxicity, ECOG PS Eastern Cooperative Oncology Group Performance Status, SAE Serious adverse event
  2. aOne patient did not receive bevacizumab
  3. bPatient had grade 5 left ventricular dysfunction
  4. cPatient had a worsened ECOG PS (grade 5)
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Breast Cancer Research

ISSN: 1465-542X

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