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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT00006104
Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease only, must have lytic lesions No carcinomatous meningitis or untreated or uncontrolled brain parenchymal disease Prior brain parenchymal disease allowed if controlled by appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic from CNS disease Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure Ejection fraction greater than 45% by MUGA No myocardial infarction within the past 6 months No ischemic heart disease requiring medication No uncontrolled hypertension Other: No peripheral neuropathy grade 2 or more No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral breast cancer No active unresolved infection No history of hypersensitivity reaction to products containing Polysorbate 80 No poorly controlled diabetes mellitus Not pregnant Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers Chemotherapy: Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease No prior taxane (docetaxel or paclitaxel) Prior doxorubicin allowed if total dose less than 250 mg/m2 No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior cumulative radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: At least 7 days since prior antibiotics No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent parenteral antibiotics
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00006104
Study Brief:
Protocol Section:
NCT00006104