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Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

Phase I Study Investigating the Combined Immunotherapy With Trastuzumab and Cetuximab in Patients With Metastatic Breast Cancer With High and Moderate HER2 Expression


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pharmacokinetics and drug/drug interaction of cetuximab and

Outcome Time Frame:

repeated PK measurements week 1-13

Safety Issue:

No

Principal Investigator

Christoph Zielinski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept of Internal Medicine, Medical University Vienna

Authority:

Austria: Federal Ministry for Health and Women

Study ID:

CETRA 01

NCT ID:

NCT00367250

Start Date:

July 2006

Completion Date:

June 2011

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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