Studieoverzicht - 2008-02 A6181099

Number 2008-02 A6181099
Nickname A6181099
Status Closed Date: 10-02-2009
Inclusion closed
Other study number(s)
Participating parties/groups
Full title A randomized, Phase 3 study of sunitinib in combination with capecitabine compared with capecitabine in patients with previously treated breast cancer
Phase and type Randomized Phase III
Age > 18
Menopausal status Both pre- and postmenopausal
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
CCMO approval Not applicable Date: Nr:
EudraCT nr.
Trial Register
METC approval Yes Date: METC: Nr:
Amendments No Date:
KWF-CKS approval No Date: Nr:
News item
Sponsor Pfizer
Principal Investigator(s) A.H. Honkoop
Study manager
Central datamanagement and randomization
Monitoring Pfizer
Local datamanagement


Primary enpoint:

  • Progression Free Survival

Secondary enpoints:

  • Overall response rate
  • Duration of response
  • Overall survival
  • Two- and 3-year survival
  • Quality of life.
Main eligibility criteria:
  • Metastatic or locally advanced breast cancer
  • Measurable disease or botmetastasis only
  • Pre treatment with anthracyclines and taxane
  • Her2 positive and negative
  • >18 years
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