Between July 1988 and May 1990, we treated 45 women with newly diagnosed, unilateral, nonmetastatic, inflammatory breast cancer with an intensive neoadjuvant chemotherapy regimen (FEC-HD) repeated every 21 days, followed by surgery or radiation therapy. Evaluation of efficacy performed 3 to 4 weeks after at least 2 cycles showed disappearance of inflammatory signs in 91% of the patients and improvement in the remaining 9%. With regard to primary tumor and lymph nodes, there were 13 (28.9%) clinical complete responses, 30 (66.6%) partial responses, and 2 (4.5%) without change. No progressive disease was observed. Hematologic toxicity from this regimen was high with grade 4 neutropenia observed at day 14 in 100% of the patients. Retreatment at day 21 was possible in 83% of the cycles. Grade 1 or 2 infections occurred in 102 cycles out of 176 (57.9%). Grade 3 infections were seen in 9 cycles (5%). No septicemia or septic shock occurred. No toxic death occurred. After induction chemotherapy, locoregional treatment consisted of modified radical mastectomy in 39 patients and radiotherapy alone in 6. The mastectomy specimen showed no residual invasive tumor (primary tumor and lymph nodes) in 10 cases (25.6%). Two patients judged as partial responders were in fact histologic complete responders. The clinical and histological response rates observed appeared very promising. For this reason we are currently testing FEC-HD with or without GCSF in a randomized multicenter trial with correction of neutropenia, disease-free survival, and overall survival as main end points.