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
  Purpose

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 Intervention Phase
Metastatic Breast Cancer
Drug: Cetuximab
Drug: Trastuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Pharmacokinetics and drug/drug interaction of cetuximab and [ Time Frame: repeated PK measurements week 1-13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 32
Study Start Date: July 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cetuximab
    weekly i.v.
    Drug: Trastuzumab
    weekly i.v.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367250

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

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

Additional Information:
No publications provided

Responsible Party: Medical University Vienna, Austria, Dept of Internal Medicine I,
ClinicalTrials.gov Identifier: NCT00367250     History of Changes
Other Study ID Numbers: CETRA 01
Study First Received: August 21, 2006
Last Updated: September 27, 2010
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cetuximab
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014