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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00367250
First received: August 21, 2006
Last updated: September 27, 2010
Last verified: September 2010

August 21, 2006
September 27, 2010
July 2006
June 2011   (final data collection date for primary outcome measure)
Pharmacokinetics and drug/drug interaction of cetuximab and [ Time Frame: repeated PK measurements week 1-13 ] [ Designated as safety issue: No ]
  • Pharmacokinetics and drug/drug interaction of cetuximab and
  • trastuzumab
Complete list of historical versions of study NCT00367250 on ClinicalTrials.gov Archive Site
  • Safety and tolerability of the combination treatment [ Time Frame: week 1 -13 ] [ Designated as safety issue: Yes ]
  • Response [ Time Frame: week 9 and 13 ] [ Designated as safety issue: No ]
  • Safety and tolerability of the combination treatment
  • Response
Not Provided
Not Provided
 
Safety Study of Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer
Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Cetuximab
    weekly i.v.
  • Drug: Trastuzumab
    weekly i.v.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Christoph Wiltschke, Prof +43 40400 4445 Christoph.Wiltschke@meduniwien.ac.at
Austria
 
NCT00367250
CETRA 01
No
Medical University Vienna, Austria, Dept of Internal Medicine I,
Medical University of Vienna
Not Provided
Principal Investigator: Christoph Zielinski, MD Dept of Internal Medicine, Medical University Vienna
Medical University of Vienna
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP