ORIGINAL PAPER Catharina Wenzel Æ Dagmar Hussian Æ Rupert Bartsch Ursula Pluschnig Æ Gottfried J. Locker Margarethe Rudas Æ Michael F. Gnant Raimund Jakesz Æ Christoph C. Zielinski Guenther G. Steger Preoperative therapy with epidoxorubicin and docetaxel plus trastuzumab in patients with primary breast cancer: a pilot study Received: 10 November 2003 / Accepted: 6 February 2004 / Published online: 27 May 2004 Ó Springer-Verlag 2004 Abstract Purpose: Combining anthracyclines and tax- anes are to date the most active cytotoxic treatment option in the neoadjuvant and palliative therapy of breast cancer patients. Adding trastuzumab to these cytotoxic agents can improve outcome for women with human epidermal growth factor receptor 2 (HER2)- overexpressing advanced breast cancer. We conducted a pilot study of preoperative epidoxorubicin and docetaxel plus trastuzumab in outpatient patients suffering from breast cancer. Patients and methods: Fourteen consecu- tive patients were enrolled in this prospective clinical pilot trial. Preoperative treatment consisted of weekly trastuzumab (4 mg/kg body-weight loading dose, 2 mg/ kg/week maintenance dose), in combination with weekly epidoxorubicin (30 mg/m 2 body surface area [BSA]) and docetaxel (35 mg/m 2 BSA) once a week for 6 weeks followed by 1 week off therapy. Results: Patients re- ceived a total of 30 cycles (median: 2 cycles, range: 2–3 cycles) of this therapeutic regimen. Outpatient epi- doxorubicin and docetaxel plus trastuzumab were well tolerated. A major response to this preoperative therapy regimen could be demonstrated in 12 of 14 patients (86%) leading to breast-conserving surgery in 11 of 14 patients (79%). Conclusions: We conclude that outpa- tient epidoxorubicin and docetaxel plus trastuzumab are safe in the neoadjuvant treatment of patients suffering from breast cancer, based on a favorable side-effect and activity profile. Thus, this regimen can be considered for further clinical trials. Keywords Breast cancer Æ Neoadjuvant Æ Docetaxel Æ Epidoxorubicin Æ Trastuzumab Introduction Breast cancer is the most common malignancy among women in Europe and the United States. Moreover, it is the second most common cause of cancer death in this population (Jemal et al. 2003). Preoperative chemotherapy can lead to a significant reduction in tumor size and can, therefore, improve both the rate and the cosmetic result of breast-conserving surgery. Another reason for applying preoperative che- motherapy is that the early use of cytotoxic drugs can potentially avoid resistance and possibly kill or inhibit clinically undetectable micrometastases, to prevent or delay the development of metastatic disease (Fisher et al. 1997, Scholl et al. 1994). To date, anthracyclines and taxanes are the most active drugs in the treatment of advanced breast cancer, and a combination of these is considered to produce the highest response rates in the neoadjuvant as well as in Work under the Auspices of CLEXO (Center of Excellence for Clinical and Experimental Oncology) C. Wenzel Æ D. Hussian Æ R. Bartsch Æ U. Pluschnig G. J. Locker Æ C. C. Zielinski Æ G. G. Steger (&) Department of Internal Medicine I, Division of Oncology, University Hospital of Vienna, Waehringer Guertel 18–20, 1090 Vienna, Austria E-mail: guenther.steger@meduniwien.ac.at M. Rudas Department of Pathology, University Hospital of Vienna, Vienna, Austria M. F. Gnant Æ R. Jakesz Department of Surgery, University Hospital of Vienna, Vienna, Austria C. C. Zielinski Chair of Medical Experimental Oncology, University Hospital of Vienna, Vienna, Austria C. C. Zielinski Ludwig Boltzmann Institute for Clinical Oncology, University Hospital of Vienna, Vienna, Austria J Cancer Res Clin Oncol (2004) 130: 400–404 DOI 10.1007/s00432-004-0559-6