NeoSphere – Study Design
NeoSphere
Gianni L. et al. Lancet Oncol 2012
S
U
R
G
E
R
Y
Study dosing: q3w x 4
TH (n=107)
docetaxel
(75
100 mg/m
2
)
trastuzumab
(8
6 mg/kg)
THP (n=107)
docetaxel
(75
100 mg/m
2
)
trastuzumab
(8
6 mg/kg)
pertuzumab
(840
420 mg)
HP (n=107)
trastuzumab
(8
6 mg/kg)
pertuzumab
(840
420 mg)
TP (n=96)
docetaxel
(75
100 mg/m
2
)
pertuzumab
(840
420 mg)
HER2+ patients with operable
(T2–3, N0–1, M0) or
locally advanced
(T2–3, N2–3, M0 or T4a–c, any N, M0)
or
inflammatory
(T4d, any N,M0)
breast cancer
Chemo-naïve & primary tumors >2cm
(N=417)
A randomized, multicenter, open-label phase II study
•
Primary endpoint:
Comparison of pCR rates in breast (ypT0/is) ( (TH vs THP - TH vs HP - THP vs TP)
•
Secondary endpoints:
pCR in breast and nodes (ypT0/is ypN0), Clinical response rate, Time to clinical response,
Breast conservation surgery rate and Safety
