Addition of Capecitabine to Taxane/Anthracycline Adjuvant Chemotherapy for Triple-Negative Breast Cancer

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In a Chinese phase III trial reported in the Journal of Clinical Oncology, Li et al found that the addition of capecitabine to taxane/anthracycline adjuvant therapy for triple-negative breast cancer was associated with improved disease-free survival.

Study Details

In the open-label multicenter trial, 585 patients were randomly assigned between June 2012 and December 2013 to the capecitabine group (n = 297) or a control group (n = 288). Treatment in the capecitabine group consisted of three cycles of capecitabine/docetaxel, followed by three cycles of capecitabine/epirubicin/cyclophosphamide. The control group received three cycles of docetaxel, followed by three cycles of fluorouracil/epirubicin/cyclophosphamide. The primary endpoint was disease-free survival.


  • The addition of capecitabine to adjuvant chemotherapy was associated with improved disease-free survival.
  • A numeric improvement in overall survival did not achieve statistical significance.

Efficacy Outcomes

Median follow-up was 67 months. The 5-year disease-free survival rate was 86.3% in the capecitabine group vs 80.4% in the control group (hazard ratio [HR] = 0.66, P = .044). Five-year rates were 89.5% vs 83.1% for recurrence-free survival (HR = 0.59, P = .02), 89.8% vs 84.2% for distant disease-free survival (HR = 0.63, P = .048), and 93.3% vs 90.7% for overall survival (HR = 0.67, P = .19).


Grade 3 or 4 adverse events occurred in 81.1% of the capecitabine group vs 82.6% of the control group, with the most common being alopecia (69.4% vs 71.2%). Grade 3 or 4 neutropenia occurred in 45.8% vs 41.0% of patients, and febrile neutropenia occurred in 16.8% vs 16.0%. Hand-foot syndrome of any grade occurred in 52.5% vs 33.0% and was grade ≥ 3 in 8.4% vs 0%. Grade ≥ 3 stomatitis occurred in 5.1% v 1.0%. Capecitabine dose reductions were required in 39.1% of patients. No patients died during treatment.

The investigators concluded, “Capecitabine, when added to three cycles of docetaxel followed by three cycles of a three-drug anthracycline combination containing capecitabine instead of fluorouracil, significantly improved [disease-free survival] in triple-negative breast cancer without new safety concerns.”

Zhimin Shao, MD, of the Department of Breast Surgery, Fudan University Shanghai Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.  

Disclosure: The study was supported by grants from the Ministry of Education Innovation Team and Shanghai Health System Joint Project of Key Disease. For full disclosures of the study authors, visit

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