- Results of a randomized controlled trial show that the combination of capecitabine plus docetaxel (DC) is neither safer nor more effective than standard anthracycline-based chemotherapy in early breast cancer.
- Most participants were at high clinical and genomic risk according to MammaPrint.
Why this matters
- Results counter expectations that DC would be safer and superior in efficacy.
- MINDACT Phase 3 trial involving patients with early breast cancer who underwent a second random allocation to either DC (n=652, 60.4% at high clinical/genomic risk) or standard anthracycline-based chemotherapy (n=649, 60.6% at high clinical/genomic risk).
- Primary outcome: DFS.
- Funding: Industry funders; Breast Cancer Research Foundation; NIH; others.
- No difference between groups in DFS at median 5 years of follow-up:
- 90.7% in DC group vs 88.8% in anthracycline-based group;
- HR, 0.83 (P=.26).
- No difference in DFS between subgroups with high clinical/high genomic risk:
- 88.1% DC vs 86.1% standard therapy;
- HR, 0.83 (95% CI, 0.58-1.21).
- DC group had higher rates of grade 1 neuropathy (27.1% vs 11.2%) and grade 2 hand/foot syndrome (28.5% vs 3.3%) but fewer second cancers (21 vs 32).
- Study was underpowered, so results are only suggestive and need further evaluation.