Clinical trial NCT00367250: Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer
Official title: Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2006-08-22
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pharmacokinetics and drug/drug interaction of cetuximab and
timeFrame: repeated PK measurements week 1-13
Secondary outcomes:
measure: Safety and tolerability of the combination treatment
timeFrame: week 1 -13
measure: Response
timeFrame: week 9 and 13
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept of Internal Medicine
Study officials:
affiliation: Dept of Internal Medicine, Medical University Vienna
name: Christoph Zielinski, MD
role: PRINCIPAL_INVESTIGATOR
References: