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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT00244933
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed breast cancer
* Stage IV disease
* Clinical and/or radiological evidence of metastatic disease
* Measurable disease
* Prior radiotherapy allowed provided there is ≥ 1 measurable disease site outside the radiation field
* No active CNS metastases
* Previously treated CNS metastases allowed provided disease is stable for ≥ 3 months without steroids or antiseizure medications
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Sex
* Female
Menopausal status
* Not specified
Performance status
* SWOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
Hepatic
* Bilirubin ≤3.0 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal
Renal
* Creatinine ≤ 1.5 mg/dL
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No serious systemic disorder that would preclude study compliance
* No history of another malignancy except curatively treated carcinoma of the cervix or basal cell or squamous cell skin cancer in complete remission
* No unresolved bacterial infection requiring antibiotic treatment
* No known HIV-1 positivity
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic therapy
Chemotherapy
* Prior adjuvant chemotherapy allowed
* Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed
* Patient must have failed therapy within 2 years after completion of treatment
* At least 3 weeks since prior chemotherapy
* No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
* No prior gemcitabine hydrochloride
* No other concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* At least 2 weeks since prior and no concurrent hormonal therapy
* Must have documented disease progression during prior hormonal therapy
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy
Surgery
* At least 3 weeks since prior surgery
Other
* At least 3 weeks since prior investigational therapy
* At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates)
* Dietary soy as part of a meal (e.g., tofu) allowed once a week
* No concurrent nutritional supplements, herbal agents, or high doses of antioxidants (e.g., vitamins C, D, or E) that may interact with, antagonize, alter, or imitate the potential effects of gemcitabine hydrochloride or genistein
* A single daily multivitamin is allowed
* No other concurrent immunotherapy
* No other concurrent experimental medication
* Concurrent anticoagulants, appetite stimulants, and replacement steroids allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00244933
Study Brief:
Protocol Section:
NCT00244933