Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer

Background: Weekly docetaxel therapy is currently used as a standard treatment for patients with metastatic breast cancer. Although many patients initially respond to this form of therapy, the majority will eventually develop disease progression and die from their disease. We have explored the use of combining pox vector vaccines with docetaxel. In a recent clinical trial, men with prostate cancer were given both the vaccine and docetaxel without any significant toxicity and the docetaxel did not diminish immune responses to the vaccine. Objectives: To evaluate progression free survival comparing PANVAC + docetaxel vs. docetaxel alone in patients with metastatic breast cancer. To evaluate overall survival comparing PANVAC + docetaxel vs. docetaxel alone in patients with metastatic breast cancer. To evaluate in both arms cluster of differentiation 8 (CD8+) T cell responses directed against carcinoembryonic antigen (CEA) and mucin (MUC-1) in human leukocyte antigen 2 (HLA-A2), A3, and A24 positive patients by interferon-gamma enzyme linked immunosorbent spot (ELISPOT) assay. Eligibility: Metastatic breast cancer (either male or female) with evidence of metastatic disease (must have radiographic evidence of disease) and life expectancy of at least 4 months. Patients may have received unlimited prior hormonal therapy or chemotherapy, but no prior docetaxel for metastatic disease. Hematological eligibility parameters within 16 days of starting therapy: Granulocyte count greater than or equal to 1,500/mm\^3, Platelet count greater than or equal to 100,000/mm\^3, hemoglobin (Hgb) greater than or equal to 8 Gm/dL. Design: A randomized Phase II study evaluating the role of combining docetaxel with PANVAC\[TM\]-V (recombinant vaccinia containing the genes encoding for CEA, MUC-1, lymphocyte function-associated antigen 3 (LFA-3), intercellular adhesion molecule 1 (ICAM-1) and B7.1) and PANVAC\[TM\]-F (recombinant fowlpox containing the genes encoding for CEA, MUC-1, LFA-3, ICAM-1 and B7.1) vs. docetaxel alone to determine if the addition of the vaccine can prolong the time to disease progression as well as overall survival in patients with metastatic breast cancer. Patients randomized to docetaxel alone may receive sequential therapy with PANVAC\[TM\]-V and PANVAC\[TM\]-F at time of disease progression. In patients randomized to the concurrent therapy, PANVAC\[TM\]-V will be administered to patients 3 weeks prior to the start of chemotherapy as the initial vaccine. The immune responses to CEA and MUC-1 will then be boosted by administration of PANVAC\[TM\]-F. Sargramostim or granulocyte macrophage colony stimulating factor (GM-CSF) will be administered with each vaccine inoculation for four consecutive days only for patients treated at the National cancer Institute (NCI).