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 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00020904
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed metastatic breast carcinoma
* Stage IV or recurrent disease with distant metastases
* Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease
* Progressed during therapy or within 4 months of last dose OR
* Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only
* Received prior anthracycline therapy
* Bidimensionally measurable metastatic lesion
* Bony lesions not considered measurable
* No known brain metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Menopausal status:
* Not specified
Sex:
* Female
Performance status:
* ECOG 0-1
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count greater than 125,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present)
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months
Other:
* No grade 2 or greater neuropathy (motor or sensory)
* No uncontrolled infection or other medical illness that would preclude study
* No psychiatric disorder or other condition that would preclude study
* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* No hypersensitivity to agents containing Cremophor EL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 24 hours since prior growth factor
* No concurrent trastuzumab (Herceptin)
* No concurrent immunotherapy
Chemotherapy:
* See Disease Characteristics
* No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy (except hormone replacement therapy)
Radiotherapy:
* At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered
* No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine)
* No prior radiotherapy to target lesion if only measurable lesion
* No concurrent therapeutic radiotherapy
Surgery:
* At least 1 week since prior minor surgery
* At least 3 weeks since prior major surgery
* Recovered from prior surgery
Other:
* Recovered from all prior treatment-related toxic effects (alopecia allowed)
* No other concurrent experimental anticancer medications
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00020904
Study Brief:
Protocol Section:
NCT00020904