Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT00367250
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00367250
Study Brief:
Protocol Section:
NCT00367250