Weekly intravenous recombinant humanized anti-P185(HER2) monoclonal antibody (herceptin) plus docetaxel in patients with metastatic breast cancer: A pilot study

Background: In patients with HER2-positive metastatic breast cancer (MBC), combined treatment of herceptin (H) and chemotherapy (CT) improves time to progression, response rates and survival compared with CT alone. Materials and Methods: We evaluated the safety and efficacy of weekly Docetaxel combi ned with weekly H as treatment in HER2 overexpressing MBC. Results: Prelimi nary toxicity data from 12 patients and 76 cycles of D and 80 cycles of H w ere analysed No G3/4 toxicity was observed. The most frequent non-hematolog ic toxicities were fatigue (2 patients G2, 2 patients G2), dyspepsia (1 pat ients G2, 3 patients G1), diarrhea (1 patient G2, 3 patients G1), and nause a (1 patient G2, 3 patients G1). Six partial responses have been observed i n 12 patients (ORR 50%). Conclusions: The combination of weekly Docetaxel a nd Herceptin is well tolerated with significant anti-tumor activity.