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Abstract:
This review summarizes the available data of phase II and phase III single-agent trials with predminustine and one phase II trial of prednimustine in combination with methotrexate, 5-fluorouracil, and tamoxifen in the treatment of advanced breast cancer. The data available so far indicate that the drug is more active than in combined treatment with the two components, chlorambucil and prednisolone. Future trials should be designed to analyze whether this could be ascribed to a sustained release of the components from the parent drug. The data also indicate that prednimustine is as active but less toxic than cyclophosphamide, but this needs to be confirmed in ongoing randomized comparisons. A number of phase II and phase III trials with prednimustine as a part of combinations are in progress. Mature results from these studies are needed to define the future role of prednimustine in the systemic therapy of breast cancer.