- A phase 3 trial from China finds that add-on capecitabine improved DFS in patients with nonmetastatic, newly diagnosed triple-negative breast cancer (TNBC).
Why this matters
- Current treatment guidelines mention the benefit of add-on capecitabine, but without a firm recommendation because of a lack of evidence to date.
- The results of this trial suggest that capecitabine should be formally incorporated into treatment guidelines.
- Phase 3, open-label, randomized controlled trial (RCT; CBCSG010) of add-on capecitabine vs control (N=585).
- Add-on capecitabine consisted of 3 cycles of capecitabine plus docetaxel followed by 3 cycles of capecitabine plus epirubicin and cyclophosphamide.
- Control consisted of 3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide.
- Funding: Chinese Ministry of Education; other.
- Median follow-up, 67 months.
- The capecitabine group had a higher 5-year DFS rate vs the control group (86.3% vs 80.4%; HR, 0.66; P=.044).
- The capecitabine had numerically higher but not significantly better 5-year OS (93.3% vs 90.7%, respectively).
- No new safety signal emerged, but 39.1% of capecitabine patients needed dose reductions.
- Open-label design.