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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00093834
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Stage IV disease
* Stable disease for ≥ 28 days
* Measurable or evaluable disease OR no evidence of disease
* Not eligible for potentially curative therapy
* Adequately treated CNS metastases are allowed
* Hormone receptor status:
* Not specified
* HER-2/neu status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2.0 mg/dL (unless due to Gilbert's syndrome)
* AST and ALT ≤ 2 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 5 times ULN
Renal
* Creatinine \< 2.0 mg/dL
Cardiovascular
* Ejection fraction ≥ 45% by echocardiogram or MUGA
Pulmonary
* Asthma or chronic obstructive pulmonary disease allowed provided daily systemic corticosteroid therapy is not required
Immunologic
* No active autoimmune disease requiring systemic immunosuppressive therapy, including any of the following:
* Inflammatory bowel disease
* Systemic vasculitis
* Scleroderma
* Psoriasis
* Multiple sclerosis
* Hemolytic anemia
* Immune-mediated thrombocytopenia
* Rheumatoid arthritis
* Systemic lupus erythematosus
* Sjögren's syndrome
* Sarcoidosis
* Other rheumatologic disease
* HIV negative
* No active acute or chronic infection
* No allergy to corn
Other
* No other malignancy within the past 5 years except carcinoma in situ of the cervix, superficial nonmelanoma skin cancer, or superficial bladder cancer
* No active major medical or psychosocial problem that would preclude study participation
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 28 days since prior biologic therapy
* No other concurrent biologic therapy, including trastuzumab (Herceptin®)
Chemotherapy
* Prior adjuvant chemotherapy allowed
* Prior doxorubicin and cyclophosphamide allowed
* Prior doxorubicin dose combined with planned study therapy dose must not exceed a lifetime cumulative dose of ≥ 450 mg/m\^2
* More than 28 days since prior systemic chemotherapy
* No other concurrent systemic chemotherapy
Endocrine therapy
* More than 28 days since prior systemic corticosteroids
* Concurrent hormonal or endocrine therapy allowed
* No concurrent systemic corticosteroids
Radiotherapy
* More than 28 days since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* More than 28 days since prior participation in another investigational drug trial
* No other concurrent investigational drugs
* Concurrent bisphosphonates allowed
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00093834
Study Brief:
Protocol Section:
NCT00093834