The validity of giving adjuvant capecitabine after standard anthracycline and/or taxanes based neo-/adjuvant chemotherapy in early triple-negative breast cancer patients: An Egyptian prospective multicentric phase III trial

Background : Triple-negative breast cancer (TNBC) is considered an aggressive breast cancer subtype despite giving standard therapies, these patients have high metastatic and relapse rates in addition to short survival. Therefore, we conducted this trial to study the validity of giving adjuvant Capecitabine, after receiving standard neoadjuvant /adjuvant chemotherapy in operable TNBC patients. The primary end point was disease-free survival (DFS) and secondary end points were overall survival (OS) and safety profile. Material and Methods : The 89 eligible patients were randomly assigned into two groups (A “Capecitabine arm” and B “observation arm”) after receiving neo/adjuvant anthracycline and/or taxanes-containing chemotherapy. Results : 78.7% were invasive duct carcinoma (IDC), and a median age was 48 years. 50.6% were node positive patients. 79.5% received adjuvant anthracyclines and taxanes chemotherapy protocol for group A and (75.6%) for group B. (56.2%) underwent breast-conservative surgery. regarding 4-year disease free survival (DFS), there was statistically significant difference between both groups (P = 0.032) and 4-y overall survival (OS) (P = 0.050)) with an acceptable toxicity profile in the Capecitabine arm. Conclusions : Our study showed statistically significant increase in DFS and OS after giving adjuvant Capecitabine to standard Neo-/Adjuvant chemotherapy in early TNBC patients with acceptable toxicity of Capecitabine arm. However, a larger study with more number of patients is recommended to give more statistical powered results.