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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT00041067
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV breast cancer
* Metastasis to the ipsilateral supraclavicular lymph nodes allowed
* HER2-positive by fluorescence in situ hybridization (FISH) or immunohistochemistry 3+ staining confirmed in the adjuvant or metastatic setting
* No effusions or ascites as only sites of disease
* No primary or metastatic brain or central nervous system tumor
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin normal
* aspartate aminotransferase or Alanine aminotranferease no greater than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Not specified
Cardiovascular:
* left ventricular ejection fraction normal by multigated radionuclide angiography or echocardiogram (patients who have received prior anthracycline therapy)
* No clinical evidence or history of cardiomyopathy
Other:
* No pre-existing grade 2 or greater motor or sensory peripheral neuropathy except abnormalities due to cancer
* No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
* 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 other adequately treated stage I or II cancer currently in complete remission
* No known sensitivity to E. coli-derived proteins
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* At least 6 months since prior chemotherapy
* Prior anthracycline as adjuvant therapy allowed
* No prior cumulative dose of doxorubicin more than 360 mg/m\^2
* No prior cumulative dose of epirubicin more than 720 mg/m\^2
* No more than 1 prior adjuvant or neoadjuvant chemotherapy regimen for primary disease
* No prior docetaxel
* No prior vinorelbine
* Prior paclitaxel allowed
Endocrine therapy:
* Prior hormonal therapy as adjuvant therapy or for metastatic breast cancer allowed
* No concurrent hormonal therapy
Radiotherapy:
* At least 3 weeks since prior radiotherapy
Surgery:
* At least 2 weeks since prior surgery and recovered
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00041067
Study Brief:
Protocol Section:
NCT00041067