CHAT Randomization Scheme

1
CHAT Randomization Scheme
RANDO MIZATION
TDC Capecitabine 950 mg/m2 b.i.d., day 114
Docetaxel 75 mg/m2, day 1 Trastuzumab 8 mg/kg
(loading dose), day 1 followed by 6 mg/kg, day
1, q3w
No prior trastuzumab, docetaxel or capecitabine

• Stratification
• Prior paclitaxel
• Prior anthracycline
• Liver metastases
• Karnofsky performance status

TD Docetaxel 100 mg/m2, day 1 Trastuzumab 8
mg/kg (loading dose), day1 followed by 6
mg/kg, day1, q3w
TDC trastuzumab, docetaxel and capecitabine TD
trastuzumab and docetaxel
Adapted from Wardley et al. San Antonio Breast
Cancer Symposium 2007, abstract 309.
2
Time to Progression and Progression-free
SurvivalCHAT Results
TDC (n112) TD (n110) HR P-value
Median TTP (months) 18.6 13.6 0.70 (0.510.97) 0.0290
Median PFS (months) 17.9 12.8 0.72 (0.530.99) 0.0402
One-year survival rate(95 CI) 0.91(0.86, 0.96) 0.85(0.79, 0.92)
Two-year survival rate(95 CI) 0.75(0.66, 0.83) 0.66(0.56, 0.75)
Median OS not yet reached events in only 38.7
of patients
Adapted from Wardley et al. San Antonio Breast
Cancer Symposium 2007, abstract 309.