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Investigator(s):
Claude Sportés, M.D. Principal Investigator Phone: 301-435-5280 Fax: 301-451-5578
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Caroline Stewart, R.N., B.S.N. Research Nurse Phone: 301-451-6569 Fax: 301-451-5578 cstewartv@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed metastatic infiltrating carcinoma of the breast
• More than 18 months since prior chemotherapy or radiotherapy for non-metastatic or for metastatic disease
• CEA positive tumor by standard immunohistochemistry
• Defined as more than 30% of cells staining positive
• Measurable or evaluable disease or no evidence of disease (post surgery)
• No brain metastases
• Hormone receptor status:
• Positive or negative
• 18 and over
• ECOG 0-1
• Absolute neutrophil count > 1,000/mm³; platelet count > 90,000/mm³; no history of abnormal bleeding tendency
• Bilirubin < 1.5 mg/dL (except in patients with Gilbert’s disease); AST and ALT < 3 times upper limit of normal; hepatitis B and C negative
• No illness that would preclude study participation

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Study Outline:

• Patients receive immunization with CEA vaccine before chemotherapy
• Patients’ own white blood cells (lymphocytes sensitized by the vaccine) are collected and preserved frozen (cyro-preserved) for future use
• Patients receive paclitaxel/cyclophosphamide on days 1 through 3 plus filgrastim (G-CSF) on day 5 for 3 to 5 monthly courses
• Patients then receive doxorubicin/cyclophosphamide for 4 cycles (if not previously treated with an anthracycline)
• Patients receive fludarabine/cyclophosphamide on days 1-4, for one cycle
• Patients receive infusions of their own cryo-preserved lymphocytes
• Patients then receive recombinant vaccines at multiple time points for up to 2.5 years after the start of treatment

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/9/09
Updated: 7/14/08