Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00367250
• Other study ID #: CETRA 01
• Status: Recruiting
• Phase: Phase 1
• First received: August 21, 2006
• Last updated: September 27, 2010
• Start date: July 2006
• Est. completion date: June 2011

Study information

• Verified date: September 2010
• Source: Medical University of Vienna
• Contact: Christoph Wiltschke, Prof
• Phone: +43 40400 4445
• Email: Christoph.Wiltschke[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Cetuximab
weekly i.v.
• Trastuzumab
weekly i.v.

Locations

Country	Name	City	State
Austria	Dept of Internal Medicine	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics and drug/drug interaction of cetuximab and		repeated PK measurements week 1-13	No
Secondary	Safety and tolerability of the combination treatment		week 1 -13	Yes
Secondary	Response		week 9 and 13	No

External Links

•   Dept of Oncology, Medical University Vienna