OBJECTIVES: To evaluate the cost effectiveness of capecitabine+docetaxel combination versus docetaxel alone in the treatment of advanced and/or metastatic breast cancer in France. METHODS: This analysis was based on primary data from an open-label, randomized, multi-centre phase III clinical trial (SO14999). Unit costs reflecting the French economic context was attached to patients' use of resource, i.e. reference tariffs for consultations, daily treatment costs for drugs and mean cost per DRG for hospitalizations. Direct medical costs were analyzed from a "payer" perspective, including payments from the public health insurance, private supplementary health insurers, and patients' co-payment. Significant differences in costs were identified with a Student's t-test for the means. To calculate incremental cost-effectiveness, the additional cost in the capecitabine arm was divided by the additional years of life saved. The time horizon of the clinical trial was 15 months and cost and health effects were not discounted. RESULTS: Survival was longer in the combination arm (mean 442 days versus 352 days). The cost of capecitabine amounted to €1786, while the cost of docetaxel was significantly reduced in the combination group (€6089 versus €7,856; p <0.0001). None of the other cost components differed between treatment groups, and the overall direct medical cost was comparable in the combination group (€9888 ± 343) and in the monotherapy group (€9852 ± 378; p = 0.9436). The additional cost in the combination arm was €36 and the clinical benefit was 0.23 life-year saved. Thus, the cost per life-year saved ratio was estimated to €157. CONCLUSIONS: Capecitabine/docetaxel combination appears as a highly cost-effective strategy in comparison to docetaxel monotherapy in the treatment of advanced or metastatic breast cancer in France, while these results derived from a randomized clinical trial need to be confirmed in current practice.