Combined Neoadjuvant Chemotherapy and Celecoxib in Locally Advanced Breast Cancer

Background: Locally advanced breast cancer is a presentation form of cancer with poor prognosis. The optimal method of treatment for these cases remains unclear. In this trial, the role of low dose celecoxib combined with neoadjuvant chemotherapy in locally advanced breast cancer was evaluated. Methods: Fifty women with pathologically proven locally advanced breast cancer were enrolled. All patients received preoperative chemotherapy with CAF (Cyclophosphamide 600 mg/m2, doxorubicin 60 mg/m2, 5-FU 600 mg/m2) regimen. They were randomly assigned into two groups. The first group received oral celecoxib (100 mg twice daily) concurrently with chemotherapy and the second group was offered placebo. Chemotherapy was administered every three weeks and celecoxib continued until one week before the surgery. The patients received an average of 3 months treatment. The size of breast mass was measured before each cycle of chemotherapy by a caliper. The pathologic response rate was the primary endpoint of the study. Results: In this trial, 50 patients were eligible, of whom 44 were evaluable. There were 25 patients in the celecoxib group and 25 patients in the placebo arm. Two patients in each group developed metastasis during the treatment course and two patients in group one could not tolerate celecoxib and quit it, so they were excluded from the trial. There was no statistically significant difference in terms of partial or complete response (90.5% vs. 87.0%) between celecoxib and placebo groups. Histological type, grade and hormonal receptor were similar in the two groups. No significant association was observed between menstrual status, size of mass at presentation and response to celecoxib. Conclusion: This study suggests that the use of celecoxib with a dose of 100 mg twice daily combined with neoadjuvant chemotherapy does not improve response rate in locally advanced breast cancer.