•
T-DM1 has demonstrated significant improvements in survival compared with lapatinib and capecitabine
in HER2-positive second-line mBC, and pertuzumab has proven efficacy in both
eBC and mBC
– The combination of the two agents offers a potential for a traditional chemotherapy-free treatment
regimen
•
KRISTINE
is a randomised, multicentre, open-label
Phase III study
of neoadjuvant
T-DM1 plus
pertuzumab vs. TCHP
in HER2-positive eBC
– Primary endpoint: pCR rate (ypT0/is, ypN0)
KRISTINE: pCR rates after neoadjuvant T-DM1
+ P vs. TCHP in patients with HER2+ EBC
HER2-positive,
operable, locally advanced
or inflammatory
eBC (>2 cm)
N = 444
Docetaxel
+ carboplatin
+ pertuzumab
+ trastuzumab
T-DM1 + pertuzumab
Surgery
Pertuzumab
+ trastuzumab
T-DM1
+ pertuzumab
Follow-up
6 cycles of neoadjuvant therapy
Hurvitz SA, et al. ASCO 2016
