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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT00036868
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic breast cancer c-erbB2 positive (3+ overexpression by the HercepTest™ method) in the primary tumor or metastatic site
* At least 1 unidimensionally measurable target lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* Lesions that have been irradiated in the preceding 3 months cannot be used as target lesions unless they have appeared or clearly progressed since prior irradiation
* No bone lesions as the only target lesions
* No contralateral breast cancer that is c-erbB2-positive or c-erbB2-negative/unknown, with status determined on a metastatic site
* No CNS metastases
* CT scan of brain and CSF cytology are required if neurologic symptoms are present
* Hormone receptor status:
* Any estrogen or progesterone receptor status
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Any status
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* Transaminases less than 2.5 times ULN (5 times ULN if liver metastases present)
Renal:
* For patients age 18 to 69:
* Creatinine no greater than ULN
* For patients age 70 and over:
* Creatinine clearance normal
Cardiovascular:
* LVEF normal by MUGA or echocardiogram
* No clinical heart failure
Pulmonary:
* No malignancy-associated dyspnea at rest
* No requirement for supportive oxygen therapy
Other:
* Not pregnant or nursing
* No other prior or concurrent malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude compliance with study therapy and follow-up schedule
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior anti-c-erbB2 antibody, including trastuzumab (Herceptin®)
* No other concurrent biologic therapy
Chemotherapy:
* No more than 1 prior chemotherapy regimen for metastatic breast cancer
* Prior combination of cyclophosphamide, methotrexate, and fluorouracil (CMF) allowed in the adjuvant or metastatic setting only if the disease-free interval after completion of CMF was at least 12 months
* Prior anthracyclines and/or taxanes allowed
* At least 4 weeks since prior anthracyclines
* 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 prior cumulative dose of mitoxantrone more than 90 mg/m\^2
* No other concurrent chemotherapy
Endocrine therapy:
* More than 2 weeks since prior hormonal therapy in the adjuvant or metastatic setting
* No concurrent hormonal therapy
Radiotherapy:
* See Disease Characteristics
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent anticancer therapy or investigational drugs
* No concurrent bisphosphonates started after study enrollment except for hypercalcemia
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00036868
Study Brief:
Protocol Section:
NCT00036868