A randomized, Phase 3 study of sunitinib in combination with capecitabine compared with capecitabine in patients with previously treated breast cancer
Indication
Advanced/Metastatic
Subindication
Any HER2, any HR
Target sample size
340
Actual accrual
430
Date: 10/02/2009
Estimated study completion date
10/02/2009
Contact
Sponsor
Pfizer
Principal Investigator(s)
A.H. Honkoop
Monitoring
Pfizer
Endpoints
Primary enpoint:
Progression Free Survival
Secondary enpoints:
Overall response rate
Duration of response
Overall survival
Two- and 3-year survival
Quality of life.
Eligibility Criteria
Metastatic orlocally advanced breast cancer Measurable disease or botmetastasis only Pre treatment withanthracyclines and taxane Her2positive and negative >18 years
