Ineffectiveness of levamisole in prolonging remission or survival of women treated with cyclophosphamide, doxorubicin, and 5-fluorouracil for good-risk metastatic breast carcinoma: a Southeastern Cancer Study Group Trial.

A total of 97 women with good-risk metastatic breast cancer received therapy with cyclophosphamide, doxorubicin, and 5-FU; half of these patients were randomly allocated to receive levamisole, 2.5 mg/kg, 2 days of each week in addition to chemotherapy, while the other half received an identical placebo. Good-risk patients consisted of those with bone-only metastasis, or local chest wall recurrence with or without bone metastasis. No significant difference in response rate, duration of disease control, or survival was observed between the groups. No major toxicity was associated with levamisole.