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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00169104
Eligibility Criteria:
Inclusion Criteria:
* All patients must have pathological confirmation of carcinoma of the breast.
* Patients must have metastatic breast cancer by documented clinical or radiological assessment.
* Immunohistochemical analysis of HER-2/neu expression on paraffin-embedded specimens will be performed. HER-2/neu overexpression will be qualitatively scored as 0, 1+, 2+, or 3+, with 3+ indicating the strongest positivity. Fluorescence In Situ Hybridization (FISH) analyses will also be performed on these patients. Patients with 2+ to 3+ overexpression of HER-2/neu (membranous staining) are eligible, regardless of the results of the FISH analysis.
* Age ≥18 years.
* Karnofsky performance status ≥ 60%.
* Adequate hepatic, renal, and hematologic function.
* Prior treatment with trastuzumab will be allowed.
* All patients must have adequate cardiac function (defined as left ventricular ejection fraction ≥ 45%) documented by echocardiogram or MUGA scan.
* Premenopausal women will be required to have a negative urine or serum pregnancy test and to use an effective form of contraception.
* Patients with a history of brain metastases are permitted as long as it has been at least 30 days since definitive treatment, they are clinically stable and a magnetic resonance imaging scan of the brain demonstrates control of the lesion(s).
* All patients must give written informed consent indicating they are aware of the investigational nature of this treatment, as well as the risks and benefits of this protocol.
Exclusion Criteria:
* No treatment with chemotherapy or trastuzumab will be allowed within four weeks of study entry.
* Prior therapy with vinorelbine.
* Known history of hypersensitivity to trastuzumab, Chinese hamster ovary (CHO) cell proteins, or any component of these products.
* History of current unstable angina, symptomatic congestive heart failure, or myocardial infarction within the last 6 months.
* Pregnant women are excluded.
* History of a known hypersensitivity to E. coli-derived proteins, filgrastim, or any component of the product.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00169104
Study Brief:
Protocol Section:
NCT00169104