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 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT00004935
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed HER2-overexpressing metastatic breast carcinoma
* Clinically or radiologically measurable or evaluable disease
* Bidimensionally or unidimensionally measurable lesions
* No ascitic, pleural, or pericardial effusions, osteoblastic bone metastases, or carcinomatous lymphangitis of the lung as only indicator lesion
* No known clinical brain or meningeal involvement
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 to 70
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-1 OR
* SAKK 0-1
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Hemoglobin at least 10 g/dL
* Platelet count at least 100,000/mm\^3
* Absolute neutrophil count at least 2,000/mm\^3
Hepatic:
* Bilirubin normal
* SGOT and/or SGPT no greater than 2 times upper limit of normal (ULN) (3 times ULN if proven liver metastases) OR
* No SGOT and/or SGPT greater than 1.5 times ULN if alkaline phosphatase greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.25 times ULN
Cardiovascular:
* LVEF normal
* No history of atrial ventricular arrhythmia, congestive heart failure, or angina pectoris, even if medically controlled
* No history of second or third-degree heart blocks
* No uncontrolled hypertension
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No pre-existing motor or sensory neuropathy grade 2 or greater
* No psychiatric disorder that would preclude informed consent
* No other prior malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
* No definite contraindications for use of corticosteroids
* No other concurrent serious illness or medical condition
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Prior adjuvant or neoadjuvant chemotherapy allowed
* No more than 2 prior chemotherapy regimens for metastatic disease
* No prior cumulative dose of doxorubicin greater than 240 mg/m\^2
* No prior cumulative dose of epirubicin greater than 360 mg/m\^2
* No prior taxanes
Endocrine therapy:
* Prior hormonal therapy as adjuvant treatment or for metastatic disease allowed
* No concurrent corticosteroids unless started more than 6 months prior to study and at low doses (i.e., no greater than 20 mg methylprednisolone or equivalent)
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No other concurrent anticancer drugs
* No other concurrent experimental drugs
* No concurrent bisphosphonates unless initiated more than 3 months prior to study
* Chronic use allowed provided bone metastases are not sole indicator lesions
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00004935
Study Brief:
Protocol Section:
NCT00004935