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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
First Posted : August 22, 2006
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
Medical University of Vienna

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Cetuximab Drug: Trastuzumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2006
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Intervention Details:
  • Drug: Cetuximab
    weekly i.v.
  • Drug: Trastuzumab
    weekly i.v.

Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics and drug/drug interaction of cetuximab and [ Time Frame: repeated PK measurements week 1-13 ]

Secondary Outcome Measures :
  1. Safety and tolerability of the combination treatment [ Time Frame: week 1 -13 ]
  2. Response [ Time Frame: week 9 and 13 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367250


Contacts
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Contact: Christoph Wiltschke, Prof +43 40400 4445 Christoph.Wiltschke@meduniwien.ac.at

Locations
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Austria
Dept of Internal Medicine Recruiting
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Christoph Zielinski, MD Dept of Internal Medicine, Medical University Vienna
More Information
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Additional Information:

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Responsible Party: Medical University Vienna, Austria, Dept of Internal Medicine I,
ClinicalTrials.gov Identifier: NCT00367250    
Other Study ID Numbers: CETRA 01
First Posted: August 22, 2006    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents