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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cetuximab

weekly i.v.

Intervention Type DRUG

Trastuzumab

weekly i.v.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Dept of Internal Medicine I,

Principal Investigators

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Christoph Zielinski, MD

Role: PRINCIPAL_INVESTIGATOR

Dept of Internal Medicine, Medical University Vienna

Locations

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Dept of Internal Medicine

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Christoph Wiltschke, Prof

Role: CONTACT

[email protected]

+43 40400 4445

Other Identifiers

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CETRA 01

Identifier Type: -

Identifier Source: org_study_id