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BACKGROUND: We evaluated the efficacy and safety of weekly paclitaxel therapy in women with locally advanced or metastatic breast cancer in an unselected hospital-based patient population. PATIENTS AND METHODS: Using a specific search tool we were able to find 49 cases in our department-based database MedicoHelp containing more than 36,000 files. All cases were evaluable. The mean number of involved sites was 2.4 (range 1-4) and 38/49 patients had visceral predominant disease. 44 patients received prior antitumor therapies, 33 patients had received prior anthracycline- and/or taxane-containing chemotherapy. Weekly paclitaxel was given at a mean dose of 80 mg/m(2) (day 1, 8, 15, repeated every 28 days), 38 patients with HER2 overexpression had a combination therapy with trastuzumab (Herceptin). Median treatment duration with paclitaxel was 4.4 months (range 0.25-9 months). A dose reduction was necessary in 5 patients. RESULTS: Therapy was tolerated well, with a 12% incidence of hematologic grade 3/4 toxicity and 22% cumulative nonhematologic grade 3 toxicity (asthenia: 5 patients, mucosa/skin: 3 patients, neurotoxicity: 3 patients). Other toxicities were rare. The overall response rate was 63%. 22% of the patients achieved disease stabilization. Symptom improvement was seen in 73% of patients. The mean time to progression was 6.0 months (range 0.25-23 months). CONCLUSIONS: Weekly paclitaxel (mostly in combination with trastuzumab) is a well-tolerated regimen and had a surprisingly high efficacy in this observation study in heavily pre-treated patients. Symptom improvement was seen in the majority of patients who responded to the treatment.