SAN ANTONIO—Capecitabine improved disease-free survival (DFS) among women with residual HER2-negative breast cancer after neoadjuvant chemotherapy, according to findings from the phase 3 CREATE-X clinical trial. The findings were presented at the 2015 San Antonio Breast Cancer Symposium.1

“These first efficacy results show that after 2 years of follow-up, disease-free survival is significantly improved by addition of capecitabine to standard therapy,” said lead study author Masakazu Toi, MD, PhD, of Kyoto University Hospital in Japan, and founder and senior director of the Japan Breast Cancer Research Group (JBCRG). “These data are exciting, because the side effects of the treatment were manageable and the benefit of capecitabine treatment was clear.”

CREATE-X was designed to evaluate this clinical question by testing whether capecitabine could improve disease-free survival for patients with residual invasive disease after neoadjuvant chemotherapy, Dr. Toi explained.

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For the study, researchers enrolled 910 patients diagnosed with HER2-negative breast cancer and residual invasive disease following neoadjuvant therapy including an anthracycline and/or a taxane.

Patients received standard hormone therapy or chemotherapy, depending on their hormone-receptor status, and were randomly assigned 1:1 to a control group receiving no additional therapy (455 patients), or a capecitabine group (455 patients) who received 8 cycles lasting 21 days each, with 1250 mg/m2 capecitabine twice a day for the first 14 days, followed by 7 days without treatment.

Two years after treatment initiation, patients in the capecitabine group had a 31% lower risk of disease recurrence compared to patients in the control group, Dr. Toi reported (DFS: 87.2% for patients administered capecitabine, compared to 80.4 in the control group).

Median overall (OS) survival was similar for the capecitabine and control groups at 2 years (96% vs 94%, respectively), but the data remain immature and OS rates may diverge over time in the future.

Tolerability “was consistent with the established safety profile,” Dr Toi noted.

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The research team is now pursuing additional analyses to see if hormone-receptor status or other factors affect the findings for some subgroups.

“This evidence might allow the development of personalized individualized treatment based on the response to primary systemic therapy,” Dr Toi concluded.


  1. Lee S-J, Toi M, Lee ES, et al. A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). Oral presentation at: San Antonio Breast Cancer Symposium 2015; December 9, 2015; San Antonio, TX.