A Randomized Phase-II Study of BB-10010 (Macrophage Inflammatory Protein- 1a) in Patients With Advanced Breast Cancer Receiving 5-Fluorouracil,

BB-10010 is a variant of the human form of macrophage inflammatory protein-1a (MIP-1a), which has been shown in mice to block the entry of hematopoietic stem cells into S-phase and to increase their self-renewal capacity during recovery from cytotoxic damage. Its use may constitute a novel approach for protecting the quality of the stem cell population and its capacity to regenerate after periods of cytotoxic treatment. Thirty patients with locally advanced or metastatic breast cancer were entered into the first random-ized, parallel group controlled phase II study. This was designed to evaluate the potential myeloprotective effects of a 7-day regimen of BB-10010 administered to patients receiving six cycles of 5-fluorouracil (5-FU), adriamycin, and cyclophosphamide (FAC) chemotherapy. Patients were ran-domized, 10 receiving 100 mg/kg BB-10010, 11 receiving 3