Metastatic Breast Cancer
Conditions
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 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.
Interventions
DRUGCetuximab
weekly i.v.
DRUGTrastuzumab
weekly i.v.
Sponsors
Medical University of Vienna
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics and drug/drug interaction of cetuximab and | repeated PK measurements week 1-13 |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of the combination treatment | week 1 -13 |
| Response | week 9 and 13 |
Countries
Austria
Contacts
Primary ContactChristoph Wiltschke, Prof
Outcome results
None listed