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:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT00103233
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Clinical evidence of metastatic disease
* HER2-positive tumor, as indicated by one of the following methods:
* HER2 gene amplification by fluorescence in situ hybridization
* HER2 protein overexpression (3+) by immunohistochemistry
* Disease progression during or after prior taxane therapy (single-agent paclitaxel, docetaxel, or taxane-containing combination chemotherapy) in combination with trastuzumab (Herceptin®) as first- or second-line chemotherapy for metastatic disease
* Patients who received maintenance therapy with single-agent trastuzumab after acheiving a response or stable disease to prior taxane/trastuzumab combination therapy are eligible provided disease has progressed
* Measurable or nonmeasurable disease
* No effusions or ascites as the only sites of disease
* No leptomeningeal disease or lymphatic pulmonary metastases
* Brain metastases allowed provided disease is stable for \> 3 months after completion of prior radiotherapy to the brain
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL
Hepatic
* Bilirubin ≤ 2.0 mg/dL
* SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN in the presence of liver metastases)
* Alkaline phosphatase ≤ 3 times ULN (\< 5 times ULN in the presence of liver or bone metastases)
Renal
* Creatinine ≤ 2.0 mg/dL
* Calcium ≤ 11.0 mg/dL
Cardiovascular
* No history of significant symptomatic cardiac disease
* LVEF ≥ 50% of the lower limit of normal by MUGA or ECG
Other
* No pre-existing clinically significant (≥ grade 2) motor or sensory neuropathy except for abnormalities due to cancer
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* At least 28 days since prior trastuzumab
* No concurrent filgrastim (G-CSF)
Chemotherapy
* See Disease Characteristics
* No more than 2 prior chemotherapy regimens for metastatic breast cancer
* Prior adjuvant/neoadjuvant chemotherapy allowed, for a total of 3 prior regimens
* No prior vinorelbine
* No other prior chemotherapy after progression on a taxane/trastuzumab regimen
* No prior cumulative dose \> 360 mg/m\^2 of anthracycline-based chemotherapy
Endocrine therapy
* No prior hormonal therapy after progression on a taxane/trastuzumab regimen
* Prior exogenous hormonal therapy for stage IV disease and/or as adjuvant therapy allowed
Radiotherapy
* See Disease Characteristics
* No prior radiotherapy to \> 50% of the marrow-bearing bone
Surgery
* At least 4 weeks since prior major surgery (2 weeks for minor surgery) and recovered
Other
* Concurrent bisphosphonates allowed for bone metastasis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00103233
Study Brief:
Protocol Section:
NCT00103233