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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT00005635
Eligibility Criteria:
DISEASE CHARACTERISTICS: HER2 overexpressing (3+) metastatic breast cancer by immunohistochemistry, or amplified by fluorescent in situ hybridization (FISH) No prior chemotherapy for breast cancer metastases No bilateral disease Bidimensionally measurable disease At least 1 target lesion greater than 1 cm2 No significant lymphedema in the arm ipsilateral to mastectomy site, unless patient has an indwelling catheter for the purpose of chemotherapy infusion No CNS metastases Hormone receptor status: Not specified
PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT, AST, and alkaline phosphatase no greater than 2.5 times ULN (no greater than 4.0 times ULN with liver or bone metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina, intractable arrhythmia, congestive heart failure, or New York Heart Association class II-IV heart disease) Left ventricular ejection fraction at least 50% or above lower limit of normal, whichever is lower Other: No severe hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide for injection concentrate) No other serious medical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 14 days since prior immunotherapy No prior trastuzumab (Herceptin) No other concurrent immunotherapy Chemotherapy: See Disease Characteristics Prior cytotoxic chemotherapy allowed in adjuvant setting Prior cumulative doxorubicin exposure no greater than 300 mg/m2 At least 1 year since prior taxane therapy No other concurrent chemotherapy Endocrine therapy: At least 14 days since prior hormonal therapy No concurrent hormonal therapy (e.g., tamoxifen, megestrol acetate, fluoxymesterone, or aminoglutethimide) Radiotherapy: At least 14 days since prior radiotherapy No concurrent radiotherapy to target lesions Surgery: Not specified Other: At least 30 days since other prior investigational agent or procedure No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00005635
Study Brief:
Protocol Section:
NCT00005635