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Status unknownNCT00367250Updated Sep 28, 2010

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

A Phase 1 interventional study of Cetuximab and Trastuzumab in Metastatic Breast Cancer, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-28.

Sponsored by Medical University of Vienna · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

02

Conditions studied

  • Metastatic Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 32 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Interventions

  • DrugCetuximab

    weekly i.v.

  • DrugTrastuzumab

    weekly i.v.

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What researchers measure

Primary outcomes

  1. Pharmacokinetics and drug/drug interaction of cetuximab and

    Time frame: repeated PK measurements week 1-13

Secondary outcomes

  1. Safety and tolerability of the combination treatment

    Time frame: week 1 -13

  2. Response

    Time frame: week 9 and 13

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Study locations

1 of 1 sites recruiting
  • Dept of Internal Medicine
    Vienna, 1090, Austria
    Recruiting
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00367250
Lead sponsor
Medical University of Vienna
First posted
Aug 22, 2006
Start date
Jul 2006
Primary completion
Jun 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Sep 28, 2010

Study contacts

Christoph Wiltschke, Prof
Contact
Christoph.Wiltschke@meduniwien.ac.at
+43 40400 4445
Christoph Zielinski, MD
principal investigator · Dept of Internal Medicine, Medical University Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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