The primary objective of this open-label, single-arm trial is to determine if preoperative administration of NOV-002 in combination with eight cycles of chemotherapy (four of doxorubicin and cyclophosphamide followed by four of docetaxel) results in an appreciably higher pathologic complete response (pCR) rate than expected with this same chemotherapeutic regimen alone. According to the Simon two-stage trial design, if four or more pCRs are observed in the first stage of the trial (19 women), enrollment would continue into the second stage, for a total of 46 women.
To date, 16 women have been enrolled with four pCRs already demonstrated in the first eight women that have both completed chemotherapy and undergone surgery. Furthermore, NOV-002 was associated with decreased hematologic toxicities and with decreased use of growth factors relative to historical experience. Full enrollment of 46 patients is expected mid-2009, with trial conclusion in early 2010.