Background: The aim of this study was to evaluate chemotherapy side-effects, quality of life (QL) and monetary costs of a French national protocol (cycle 1: Cyclophosphamide (C) 6gr/m 2 , Doxorubicin (D) 75mg/m 2 ; cycle 2: C 3gr/m 2 , D 75mg/m 2 ; cycle 3: cycle 2 + 5FU 2500mg/m 2 ; cycle 4 cycle 3; mastectomy; radiotherapy) proposed to IBC patients (pts), in order to complete its clinical evaluation. Contrary to conventional graft, this intensive chemotherapy may be administered in outpts.Methods: Pts were included in this study between 12/94 and 09/96. Physical symptoms due to chemotherapy were assessed in terms of frequency, duration/severity and distress using a self-administered questionnaire including 19 side-effects and completed by pts at the 4th cycle. The multidimensional QL was evaluated by means of the EORTC QLQ-C30 administered : (a) prior the start of the treatment (b) at the 4th cycle of chemotherapy and at the end of radiotherapy (c) 1 month after the treatment and every year until 3 years. Variables for the evaluation of monetary costs were collected both in case report forms and by using a specially designed indirect cost form completed by pts at the end of the treatment and during the 3 years follow-up.Results: 100 pts were included in the protocol. The current estimation of the return rate of questionnaires is 84% during the treatment and 65% during the follow-up. At the 4th cycle, tiredness, alopecia, lack of appetite, nausea, vomiting, change in taste, fever and weight loss were reported by 96 % to 63% of pts. Most of symptoms were distressing for patients, the most distressing being mucitis, vomiting, change in taste and stomach pain. At the end of chemotherapy the scores of the EORTC functioning scales (physical, role, cognitive, social and global QL) were statistically significantly lower than baseline scores. At the end of radiotherapy, these scores regained baseline values except for physical and role scores (p<0.05). One year after inclusion in the treatment, all functioning scores were not statistically different from pre-treatment values excepted role score (p<0.05).Discussion: The protocol proposed to pts had an important adverse effect on QL, but this effect disappeared at the end of radiotherapy for several QL dimensions and for nearly all QL dimensions 1 year after inclusion. The cost study will be performed on the 100 pts, when all case report forms will be filled, to assess the ratio cost-effectiveness of this therapy. These results will be compared with those of 2 historical groups of IBC pts treated by high dose chemotherapy with conventional graft or by conventional chemotherapy + radiotherapy sequence.