Capecitabine
1250 mg/m
2
BID orally
Days 1-14, q21 days
Study 301: Study Schema
Patients
(planned N=1100)
● Locally advanced or
MBC
● ≤3 prior chemotherapies
(≤2 for advanced disease)
● Prior anthracycline and
taxane in (neo)adjuvant
setting or for locally
advanced / metastatic
disease
Eribulin
1.23 mg/m
2
,
*
2-5 min IV
Day 1 & 8 q21 days
Randomization 1:1
Stratification
–
Geographical region, HER2/
neu
status
Co-Primary End
Point
● OS and PFS
Secondary End
Points
● Quality of life
● ORR
● Duration of
response
● 1-, 2- and 3-year
Survival
● Tumour related
symptom
assessments
● Safety parameters
● Population PK
(eribulin arm only)
*Equivalent to 1.4 mg/m
2
eribulin mesilate.
BID=twice daily; HER2=human epidermal growth factor receptor type 2; IV=intravenous;
MBC=metastatic breast cancer.
