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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00025493
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed breast cancer
* Distant metastatic disease confirmed by histology, cytology, or strong clinical evidence
* Measurable disease
* No known brain or CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 70 and over OR
* Under 60
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Hemoglobin at least 9 g/dL
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT or SGPT no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)
* Alkaline phosphatase no greater than 1.5 times ULN (2.0 times ULN if liver metastases are present)
Renal:
* Creatinine no greater than ULN
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* HIV negative
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy for breast cancer
Chemotherapy:
* Prior adjuvant or neoadjuvant chemotherapy allowed
* Prior adjuvant taxanes allowed
* No other concurrent chemotherapy for breast cancer
Endocrine therapy:
* Prior hormonal therapy in the adjuvant setting or for metastatic disease allowed
* No concurrent hormonal therapy for breast cancer
Radiotherapy:
* No concurrent radiotherapy for breast cancer
Surgery:
* Not specified
Other
* No more than 1 prior regimen for advanced, recurrent, or metastatic disease
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00025493
Study Brief:
Protocol Section:
NCT00025493