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 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT00243503
Eligibility Criteria:
Inclusion Criteria:
* A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
* HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive)
* Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Exclusion Criteria:
* Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
* Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
* Prior treatment on a SU11248 clinical trial.
* Uncontrolled brain metastases.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00243503
Study Brief:
Protocol Section:
NCT00243503