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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00052351
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast
* Stage II or III
* At least 4 positive lymph nodes
* No inflammatory ductal carcinoma
* No positive lymph nodes by immunohistochemistry only
* Carcinoembryonic antigen (CEA) expression, as indicated by 1 of the following:
* At least 30% of tumor stains for CEA on immunohistochemistry
* Elevated serum CEA (greater than 5 ng/mL) anytime during disease course
* Must be HLA-A2 positive
* Must have received prior vaccinia for smallpox immunization with 1 of the following as evidence:
* If age 25 and under, physician certification of prior vaccination
* If over age 25, patient recollection and vaccination-site scar
* Any age, detectable anti-vaccinia antibodies
* No metastases by CT scan of chest, abdomen, and pelvis and a bone scan
* Hormone receptor status:
* Estrogen receptor status and progesterone receptor status known
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status:
* Not specified
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 1.5 times ULN
* Hepatitis B and C negative
Renal
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance greater than 60 mL/min
* No proteinuria OR
* Protein less than 1,000 mg per 24-hour urine collection
* No hematuria
* No abnormal sediment
Cardiovascular
* LVEF at least 45% by echocardiogram or MUGA if either of the following are true:
* History of cardiac disease
* Received prior cardiotoxic chemotherapy
Immunologic
* No evidence of immunocompromised status
* No autoimmune disease such as any of the following:
* Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
* Systemic lupus erythematosus
* Sjogren's syndrome
* Scleroderma
* Myasthenia gravis
* Goodpasture syndrome
* Addison's disease
* Hashimoto's thyroiditis
* Active Graves' disease
* No active or prior eczema or other eczematoid skin disorders
* No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
* HIV negative
* No active infection within the past 3 days
* No allergy to eggs
* No history of allergy or untoward reaction to prior vaccination with vaccinia virus
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other serious illness
* No other malignancy within the past 3 years except squamous cell or basal cell skin cancer
* No history of seizures, encephalitis, or multiple sclerosis
* No active inflammatory bowel disease
* Must be able to avoid close household contact with the following during and for 2 weeks after vaccinations:
* Persons with active or prior eczema or other eczematoid skin disorders
* Persons with any other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
* Pregnant or nursing women
* Children under 5 years old
* Immunodeficient or immunosuppressed persons (by disease or therapy), including those with HIV infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* No prior doxorubicin, cyclophosphamide, or paclitaxel
Endocrine therapy
* No concurrent steroids except the following:
* Topical steroids
* Inhaled steroids for moderate asthma
* Dexamethasone prior to taxanes
Radiotherapy
* No prior radiotherapy to more than 50% of the lymph nodes
Surgery
* At least 2 weeks since prior surgery and recovered
* No prior splenectomy
Other
* No other concurrent anti-tumor therapies
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00052351
Study Brief:
Protocol Section:
NCT00052351