CREATE-X Study in Breast Cancer

  • The CREATE-X study:
    • Randomly assigned 910 patients with HER2 negative breast cancer and residual disease after undergoing neoadjuvant chemotherapy:
      • To standard postsurgical treatment and capecitabine or placebo
  • The primary end point:
    • Was disease-free survival (DFS)
  • Secondary end points included:
    • Overall survival (OS)
  • DFS was longer in the capecitabine group than in the control group (placebo):
    • 74.1% vs. 67.6% of the patients were alive and free from recurrence or second cancer at 5 years
  • Among patients with triple-negative disease:
    • DFS was 69.8% in the capecitabine group versus 56.1% in the control group
  • OS rate was 78.8% versus 70.3%
  • There is no role for tamoxifen or anastrozole in triple negative breast cancer
  • Residual disease after completion of neoadjuvant chemotherapy:
    • Is associated with worse outcomes


1. Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, et al. Adjuvant capecitabine for breast cancer after preoperative chemotherapy. N Eng J Med. 2017;376(22):2147-2159.

2. Symmans WF, Wei C, Gould R, Yu X, Zhang Y, Liu M, et al. Long-term prognostic risk after neoadjuvant chemotherapy associated with residual cancer burden and breast cancer subtype. J Clin Oncol. 2017;35(10):1049-1060.

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