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 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT00107393
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Metastatic disease
* Patients with only bone metastases are not eligible
* Refractory disease, defined as disease progression, drug-related adverse reaction, or disease relapse during or within 12 months after completion of paclitaxel or docetaxel AND doxorubicin or epirubicin administered in the neoadjuvant, adjuvant, or metastatic setting
* Total neoadjuvant or adjuvant taxane dose \> 700 mg/m\^2 for paclitaxel or \> 240 mg/m\^2 for docetaxel
* Total taxane dose \> 350 mg/m\^2 for paclitaxel or \> 120 mg/m\^2 for docetaxel in the metastatic setting
* Total neoadjuvant or adjuvant anthracycline dose \> 240 mg/m\^2 for doxorubicin or epirubicin
* Total anthracycline dose \> 120 mg/m\^2 for doxorubicin or epirubicin in the metastatic setting
* HER2/neu overexpression
* 3+ by immunohistochemistry or positive by fluorescence in situ hybridization
* No symptomatic brain metastases
* No pleural or pericardial effusion or ascites
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 20 to 75
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-2
Life expectancy
* At least 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* SGOT or SGPT ≤ 2.0 times upper limit of normal (ULN) (\< 3.0 times ULN for patients with liver metastases)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine ≤ 1.2 mg/dL
Cardiovascular
* LVEF \> 50%
Pulmonary
* No interstitial pneumonia with pulmonary fibrosis
Other
* No history of hypersensitivity reactions
* No serious, uncontrolled infection
* No other malignancy
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior trastuzumab (Herceptin®) for metastatic disease allowed
Chemotherapy
* See Disease Characteristics
* No prior capecitabine
* At least 2 weeks since prior antimetabolites for metastatic disease
* At least 4 weeks since prior alkylating agents, carcinostatic antibiotics, or other carcinostatic agents
Endocrine therapy
* At least 4 weeks since prior goserelin or leuprolide for metastatic disease
* At least 2 weeks since prior oral endocrine agents for metastatic disease
* No concurrent endocrine therapy
Radiotherapy
* No prior radiotherapy to target lesions
* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy, including radiotherapy for brain metastases
Surgery
* Not specified
Other
* Concurrent bisphosphonates for bone metastases allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT00107393
Study Brief:
Protocol Section:
NCT00107393