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

September 27, 2010 updated by: Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Metastatic Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Vienna, Austria, 1090
    - Recruiting
    - Dept of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics and drug/drug interaction of cetuximab and Time Frame: repeated PK measurements week 1-13	repeated PK measurements week 1-13

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of the combination treatment Time Frame: week 1 -13	week 1 -13
Response Time Frame: week 9 and 13	week 9 and 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

Principal Investigator: Christoph Zielinski, MD, Dept of Internal Medicine, Medical University Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Dept of Oncology, Medical University Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)