Phase III Study of Adjuvant Capecitabine Metronomic Chemotherapy in Triple-negative Operable Breast Cancer
Triple negative (ER-/PR-/HER2-) breast cancer (TNBC) is an aggressive disease without
tumor-specific treatment options. Patients with triple-negative disease had an increased
likelihood of distant recurrence and death within 5 years of diagnosis. Median time to
distant recurrence was significantly shorter.This study will evaluate the efficacy and
safety of the addition of Capecitabine (Xeloda) to standard adjuvant therapy in patients
with triple negative breast cancer. Patients will be randomized to receive either standard
chemotherapy (according to NCCN guideline), or standard chemotherapy followed by 1 year of
metronomic Capecitabine (650mg/m2, twice every day). The anticipated time on study treatment
is 6-12 months, and the target sample size is 424 individuals.Disease-free Survival (DFS)
will be primary end point.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The interim analysis and the final analysis are expected ot occur 18 and 36 months after the end of recruitment.
Yuan Zhong-yu, MD
Sun Yat-sen University
United States: Institutional Review Board