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About
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission.
Full description
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive recombinant modified vaccinia Ankara-5T4 vaccine (TroVax®) intramuscularly once a month in months 1-3. Patients then receive booster vaccinations once in months 6, 9, and 12. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 2 years.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Stage IIIB-IV disease
In remission (no evidence of disease)
Hormone receptor status:
PATIENT CHARACTERISTICS:
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Hematopoietic
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PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 28 days since prior and no concurrent treatment on another clinical trial
Concurrent bisphosphonates allowed provided it is not part of treatment on another clinical trial
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Data sourced from clinicaltrials.gov
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