Status:
UNKNOWN
Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer
Lead Sponsor:
Medical University of Vienna
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
One important approach to change the natural history of advanced breast cancer is that of designing new combination chemotherapies in which the best drugs already available are used together with new ...
Eligibility Criteria
Inclusion
- diagnosis of metastatic breast cancer
- presence of at least 1 measurable lesion according to modified RECIST criteria
- Evidence (fluorescence in situ hybridization FISH) of
- Her-2 overexpression in tumor tissue:Group A: Her-2 +++, Group B: Her-2 + or ++
- EGFR-expressing disease as assessed by immunohistochemistry
- Recovered from relevant toxicities from other treatment prior to study entry
Exclusion
- Prior treatment with trastuzumab for metastatic breast cancer (adjuvant therapy is allowed)
- Prior treatment with cetuximab
- Concomitant cytotoxic chemotherapy
- Treatment with any investigational agent(s) within 4 weeks prior to study entry
- Known allergic/hypersensitivity reaction to any of the components of study treatments
- severe dyspnea
- Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment
- History of significant neurologic or psychiatric disorders
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00367250
Start Date
July 1 2006
End Date
June 1 2011
Last Update
September 28 2010
Active Locations (1)
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1
Dept of Internal Medicine
Vienna, Austria, 1090