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 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT00003432
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed metastatic breast cancer that expresses carcinoembryonic antigen (CEA)
* At least 25% of the tumor cells must stain positive for CEA with at least moderate intensity
* Must have achieved either partial response or complete response after high dose chemotherapy and peripheral blood stem cell transplant
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Menopausal status:
* Not specified
Performance status:
* Karnofsky 70-100%
Life expectancy:
* Greater than 6 months
Hematopoietic:
* Absolute neutrophil count at least 1000/mm\^3
* Absolute lymphocyte count at least 1000/mm\^3
* Hemoglobin at least 9 mg/dL
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 2.0 mg/dL
* No serious ongoing chronic or acute hepatic disease
Renal:
* Creatinine less than 2.5 mg/dL
Cardiovascular:
* No serious ongoing chronic or acute cardiac disease (New York Heart Association class III or IV)
Pulmonary:
* No serious ongoing chronic or acute pulmonary illness such as asthma, chronic obstructive pulmonary disease, or radiation or drug induced pneumonitis
Other:
* No other prior or concurrent malignancy except nonmelanoma skin cancer or controlled superficial bladder cancer within the past 5 years
* No history of autoimmune disease such as inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, or multiple sclerosis
* No inflammatory bowel condition such as active infectious enteritis or eosinophilic enteritis
* No active acute or chronic infection such as urinary tract infection, HIV, or viral hepatitis
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* No concurrent immunotherapy
Chemotherapy:
* See Disease Characteristics
* No concurrent chemotherapy
Endocrine therapy:
* At least 4 weeks since steroids
* No concurrent steroid therapy
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No concurrent immunosuppressive agents such as azathioprine or cyclosporine A
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003432
Study Brief:
Protocol Section:
NCT00003432