15 / 16
Timepoint, n/N1 (%)
ABP 980
(n=364)
Trastuzumab
(n=361)
Visit 9*
1/345 (0.3)
2/344 (0.6)
End of neoadjuvant phase
0/5 (0.0)
1/5 (20.0)
Overall
1/350 (0.3)
3/348 (0.9)
AE category, n (%)
ABP 980
(n=364)
Trastuzumab
(n=361)
Any treatment-emergent AE
292 (80.2)
287 (79.5)
Any grade
³
3 treatment-emergent AE
54 (14.8)
51 (14.1)
Any fatal treatment-emergent AE
1 (0.3)
0 (0.0)
*3 (0.8%) and 2 patients (0.6%) experienced serious AEs that were considered by the investigator to be related to IP
Incidence of LVEF Decline by ≥10% and to <50%
von Minckwitz et al. ESMO 2017, Poster discussion 151 PD
Escenario Neoadyuvancia
Fase III – ABP 980