Bevacizumab+CAPECITABINE in 1L MBC
Investigator’s
choice of
chemotherapy
Capecitabine
or taxane/
anthracycline
Optional
2nd-line
chemo
+
Beva
Treat to
disease
progression
RANDOMISE 2:1
Beva
+ Capecitaine
Placebo
+ Capecitabine
Beva
+ taxane/anthra
Placebo
+ taxane/anthra
Previously
untreated
LR/mBC
n=1237
Stratification
factors:
•
DFI
•
Previous
(neo)adjuvant
chemotherapy
•
No. of
metastatic sites
•
Taxane or
anthracycline
RIBBON-1: Pragmatic Trial Design
•
Primary endpoint:
–
PFS (investigator assessed)
• Secondary endpoints:
– OS and 1-year OS rate; ORR; DoR; PFS (assessed by IRC) and Safety
Robert et al JCO 2011
