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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT00639366
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven breast carcinoma
* Metastatic or locally advanced disease
* Must demonstrate HER2 3+ positivity on IHC or 2+ over-expression and FISH test demonstrating C-erB2 gene amplification
* No known or suspected brain metastases or CNS disease, as defined by the presence of any of the following key symptoms:
* Headache
* Nausea and/or vomiting
* Clinical signs of raised intracranial pressure
* Seizures
* Focal symptoms
* Cognitive dysfunction
* Affective disorder
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal status not specified
* ECOG performance status 0 or 1
* Patients must a-priori be suitable for trastuzumab (Herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
* No prior history of cerebrovascular disease or neurological disorder including seizures
PRIOR CONCURRENT THERAPY:
* No prior cranial radiotherapy
* No prior neurosurgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00639366
Study Brief:
Protocol Section:
NCT00639366