Status:
COMPLETED
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combin...
Eligibility Criteria
Inclusion
- A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
- HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive)
- Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Exclusion
- Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
- Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
- Prior treatment on a SU11248 clinical trial.
- Uncontrolled brain metastases.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00243503
Start Date
February 1 2006
End Date
July 1 2010
Last Update
July 22 2011
Active Locations (27)
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1
Pfizer Investigational Site
Montgomery, Alabama, United States, 36106
2
Pfizer Investigational Site
Newark, Delaware, United States, 19713
3
Pfizer Investigational Site
Newark, Delaware, United States, 19718-6001
4
Pfizer Investigational Site
Wilmington, Delaware, United States, 19899