Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00367250
Recruitment Status : Unknown
Verified September 2010 by Medical University of Vienna. Recruitment status was: Recruiting
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 anticancer agents devoid of clinical cross-resistance. The possibility of exploiting the combined use of cetuximab and trastuzumab represents an option of potential great impact on the probability of response and long-term therapeutic results for patients with advanced breast cancer and HER2 overexpression.Therefore, patients with tumors that demonstrate EGFR expression and clear-cut erbB-2 overexpression (3+) or limited erbB-2 overexpression (+ or 2+) will be included in the study. Patients will be treated with trastuzumab and cetuximab to study the pharmacokinetics and potential drug/drug interaction of both antibodies as well as the safety and tolerability of this novel combination treatment.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
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