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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT00006120
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven unresectable locally advanced or metastatic breast cancer
* Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines
* At least one bidimensionally measurable lesion
* No brain metastasis
* No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease
* Hormone receptor status:
* Known hormone receptor status
PATIENT CHARACTERISTICS:
Age:
* 18 to 75
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2 OR
* Karnofsky 60-100%
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* AST and ALT no greater than 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 2.5 times ULN
* Bilirubin normal
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No uncontrolled angina or arrhythmia
* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease
Other:
* No sensitive neuropathy worse than grade 2
* No other significant, uncontrolled medical or psychiatric condition
* No serious active infection
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior specific antitumoral immunotherapy
Chemotherapy:
* See Disease Characteristics
* No prior taxanes
* At least 4 weeks since other prior specific antitumoral chemotherapy
Endocrine therapy:
* At least 4 weeks since prior specific antitumoral hormonal therapy
Radiotherapy:
* At least 4 weeks since prior specific antitumoral radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent experimental medication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00006120
Study Brief:
Protocol Section:
NCT00006120