Purpose: A sing le institute trial of com bination chem otherapy, w ith paclitaxel and cisplatin, in patients w ith m etastatic breast cancer, having failed previous com bination chem otherapy, w as perform ed. Materials and Methods: Patients w ere only eligible for this study if there disease had progressed, follow ing treatm ent w ith previous chem otherapy, in either an adjuvant or a m etastatic setting. Paclitaxel 175 m g/m 2 w as adm inistered as a 3-hour continuous infusion on day 1, and

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... isplatin 80 m g/m 2 was adm inistered for 2 hours on day 2, w ith adequate hydration. This w as repeated every 3 w eeks, and continued until one of the follow ing events occurred: disease prog ression, unacceptable adverse effect or treatm ent refusal by the patient. Intercurrent palliative radiotherapy, or concurrent horm onal therapy, w as perm itted, depending on each patient's status. A ll the endpoints w ere evaluated under the principle of intention to treat analysis. Results: A total of 24 patients entered the study, and 18 had at least one m easurable lesion, but 6 did not. The objective response rate of the 18 patients was 50% (9/18). Two were complete responses and seven show ed partial responses. The m edian response duration, progression free and overall survival w ere 5.3 m onths (range, 4 18), 6 m onths (95% CI, 5 7) and 12 m onths (95% CI, 7 17), respectively. 67% of the planned dose w as adm inistered. O ut of a total 135 cycles adm inistered, about 20% of cycles show ed grade 3 or 4 leukopenia and 7% show ed grade 3 throm bocytopenia. Tw o patients suffered from pneum onia, and one experienced neutropenic fever. M ucositis, greater than grade 3, existed in three cases. N o treatm ent related deaths w ere reported. Conclusion: The com bination chem otherapy, w ith paclitaxel and cisplatin, w as active in the treatm ent of m etastatic breast cancer patients having failed previous chem otherapy. (Cancer Research and Treatment 2003;35:267-273)