Introduction
Methods
Study design
Endpoints
Assessments
Statistical methods
Results
Patients
Characteristic | Patients (N = 132) |
---|---|
Female, n (%) | 132 (100) |
Median age, years (range) | 56.5 (34–81) |
ECOG performance status, n (%) | |
0 | 115 (87.1) |
1 | 17 (12.9) |
Stage of disease at initial diagnosis, n (%) | |
Stage I | 8 (6.1) |
Stage II | 31 (23.5) |
Stage IIIA | 7 (5.3) |
Stage IIIB | 7 (5.3) |
Stage IIIC | 8 (6.1) |
Stage IV | 71 (53.8) |
Site of disease, n (%) | |
Non-visceral | 51 (38.6) |
Visceral | 81 (61.4) |
Hormone-receptor status, n (%) | |
ER- and/or PgR-positive | 72 (54.5) |
ER- and PgR-negative | 60 (45.5) |
HER2 status by IHC/ISH, n (%) | |
IHC 2 + and ISH-positive | 17 (12.9) |
IHC 3 + and ISH-positive IHC 3 + and ISH unknown | 4 (3.0) 107 (81.1) |
IHC unknown and ISH-positive | 4 (3.0) |
Recurrence | |
De novo metastatic disease | 83 (62.9) |
Recurrent metastatic diseasea | 49 (37.1) |
Disease-free interval (month)b,c | |
n | 49 |
Mean (SD) | 55.7 (41.7) |
Median | 44.3 |
Min–max | 0.6–179.4 |
Prior therapies, n (%) | |
No | 94 (71.2) |
Yes | 38 (28.8) |
Anthracycline | 25 (18.9) |
Taxanes | 22 (16.7) |
Trastuzumab | 30 (22.7) |
Progression-free survival (primary endpoint)
Key secondary endpoints
Best overall response | Patients, n (% [95% CI]) (n = 118) |
---|---|
Objective response | 99 (83.9 [77.3–90.5) |
Complete response | 11 (9.3 [4.08–14.6]) |
Partial response | 88 (74.6 [66.7–82.4]) |
Stable disease | 16 (13.6 [7.38–19.74]) |
Progressive disease | 3 (2.5 [0.00–5.38]) |
Exploratory analysis of efficacy
n | Number of events, n (%) | Median PFS, months (95% CI) | HR (95% CI) | |
---|---|---|---|---|
Overall population | 132 | 70 (53.0) | 22.8 (16.9–37.5) | – |
Prior (neo)adjuvant therapya | ||||
Yes | 38 | 18 (47.4) | 27.7 (12.4–NE) | 0.91 (0.53–1.56) |
No | 94 | 52 (55.3) | 20.8 (16.9–38.8) | – |
Age | ||||
< 65 | 96 | 53 (55.2) | 22.8 (16.5–37.5) | 1.29 (0.75–2.23) |
≥ 65 | 36 | 17 (47.2) | 33.1 (18.7–NE) | – |
Site of disease | ||||
Non-visceral | 51 | 19 (37.3) | 37.5 (20.7–NE) | 0.62 (0.37–1.06) |
Visceral | 81 | 51 (63.0) | 18.4 (13.8–33.7) | – |
HER2 status IHC/ISH | ||||
IHC ≤ 2 + and ISH-positive | 21 | 13 (61.9) | 16.5 (10.4–34.8) | – |
IHC 3 + | 111 | 57 (51.4) | 22.9 (18.4–49.5) | 0.66 (0.36–1.21) |
HR status | ||||
ER- and/or PgR-positive | 72 | 41 (56.9) | 18.9 (14.7–33.1) | – |
ER- and PgR-negative | 60 | 29 (48.3) | 33.7 (20.6–NE) | 0.79 (0.49–1.27) |
Menopausal status | ||||
Premenopausal | 46 | 27 (58.7) | 22.8 (16.6–49.5) | – |
Postmenopausal | 86 | 43 (50.0) | 22.8 (14.6–NE) | 1.05 (0.65–1.70) |
Recurrence | ||||
De novo metastatic disease | 83 | 48 (57.8) | 20.7 (16.6–37.5) | – |
Recurrent metastatic diseaseb | 49 | 22 (44.9) | 28.1 (16.7–NE) | 0.77 (0.47–1.28) |
Treatment exposure
Safety
Adverse event | Patients, n (%) (N = 132) | |
---|---|---|
Any grade | Grade ≥ 3 | |
Alopecia | 122 (92.4) | 0 |
Diarrhea | 104 (78.8) | 6 (4.5) |
Neutrophil count decreased | 83 (62.9) | 82 (62.1) |
Stomatitis | 81 (61.4) | 4 (3.0) |
Taste abnormality | 75 (56.8) | 0 |
White blood cell count decreased | 70 (53.0) | 67 (50.8) |
Loss of appetite | 70 (53.0) | 7 (5.3) |
Nasopharyngitis | 69 (52.3) | 0 |
Malaise | 65 (49.2) | 0 |
Rash | 63 (47.7) | 1 (0.8) |
Nausea | 60 (45.5) | 1 (0.8) |
Peripheral edema | 57 (43.2) | 1 (0.8) |
Injection-site reaction | 53 (40.2) | 0 |
Peripheral neuropathy | 50 (37.9) | 1 (0.8) |
Muscle pain | 50 (37.9) | 1 (0.8) |
Fever | 45 (34.1) | 1 (0.8) |
Vomiting | 42 (31.8) | 1 (0.8) |
Febrile neutropenia | 42 (31.8) | 42 (31.8) |
Neutropenia | 32 (24.2) | 32 (24.2) |
Anemia | 22 (16.7) | 9 (6.8) |
Leukopenia | 14 (10.6) | 14 (10.6) |