TRYPHAENA – Study Design
Tryphaena
Trastuzumab
to complete
1 year
All three arms are experimental
FEC: 5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2; Docetaxel 75 mg/m2 (escalated to 100 mg/m2 in Arms A and B if tolerated);
Trastuzumab 8 mg/kg Cycle 1, then 6 mg/kg; Pertuzumab 840 mg loading dose, then 420 mg; Carboplatin AUC6
pCR, pathologic complete response; DFS, disease free survival; OS, overall survival; AUC, area under the curve
•
Primary endpoints:
Safety and Tolerability
Cardiac safety: Assessed by symptomatic LVSD and LVEF decline (≥10 percentage points from
baseline to <50% over the course of neoadjuvant therapy)
•
Secondary endpoints:
pCR, Clinical response rate, Rate of breast-conserving surgery, DFS, OS
Pertuzumab + trastuzumab (Cycles 1–6) +
FEC (Cycles 1–3) + docetaxel (Cycles 4–6)
FEC (Cycles 1–3)
Pertuzumab + trastuzumab + docetaxel
(Cycles 4–6)
Pertuzumab + trastuzumab + docetaxel
+ carboplatin (Cycles 1–6)
S
U
R
G
E
R
Y
HER2-positive
eBC
(N = 225)
Schneeweiss et al. Ann of Oncology 2013;
A randomized, multicenter, open-label phase II study
