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Annals of Oncology 12:S69-S73, 2001
© 2001 European Society for Medical Oncology


Symposium Article

Ongoing trials with trastuzumab in metastatic breast cancer

R. Bell

The Andrew Love Cancer Centre, Cancer Services and Medical Oncology Geelong, Australia

Correspondence to: R. Bell. MD The Andrew Love Cancer Centre Cancer Services and Medical Oncology 70 Swanson Street Geelong Victoria 3220 Australia E-mail: richardb{at}barwonhealth.org.au

Following the pivotal clinical trials of trastuzumab (Herceptin), further phase II and III studies have been initiated. Preliminary results from a phase II, dose-response study of single-agent trastuzumab in 113 HER2-positive metastatic breast cancer patients without prior chemotherapy for stage IV disease have shown that the overall response rate was 23% (six complete responses and 20 partial responses), with similar results using both standard- and high-dose regimens of trastuzumab. Another phase II study of trastuzumab plus paclitaxel, both given weekly, in-63 HER2-positive and -negative patients with metastatic breast cancer produced an overall response rate of 62% in HER2-positive and 44% in HER2-negative patients. A further phase II study is underway to investigate the combination of trastuzumab plus docetaxel in 30 HER2-positive patients with metastatic breast cancer. Finally, a number of European studies are at an advanced stage of planning or are about to start patient recruitment. These include docetaxel ± trastuzumab, aromatase inhibitor ± trastuzumab, CMF (cyclophosphamide, methotrexate, 5-fluorouracil) ± trastuzumab, vinorelbine + trastuzumab, all in HER2-positive patients, and epirubicin-cyclophosphamide (EC) + trastuzumab in HER2-positive patients vs. EC alone in HER2-negative patients. The results from these trials should be available over the next one to two years.

docetaxel, epirubicin, Herceptin, metastatic breast cancer, paclitaxel, trastuzumab


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