- Anthracycline-free neoadjuvant chemotherapy (NACT) is as effective, but safer than anthracycline-containing NACT in the presence of dual HER2 blockade in patients with HER2+ early breast cancer enrolled in the TRAIN-2 study.
Why this matters
- The authors suggest that the anthracycline-free regimen is preferred, but long-term follow-up is needed.
- Randomized controlled phase 3 trial (n=438) of:
- 5-fluorouracil, epirubicin, and cyclophosphamide followed by paclitaxel and carboplatin (anthracycline group) for 6 cycles, or
- 9 cycles of paclitaxel and carboplatin (anthracycline-free group).
- Both NACT regimens were accompanied by dual HER2 blockade with trastuzumab and pertuzumab.
- Primary outcome was percentage of patients attaining a pathologic complete response (pCR).
- Funding: Roche Netherlands.
- Median follow-up was 19 months (interquartile range, 16-23 months).
- No difference between groups on % attaining pCR (anthracycline-inclusive, 67% vs anthracycline-free, 68%; P=.95).
- The anthracycline group had higher rates of grade 3 or worse febrile neutropenia (10% vs 1% in the anthracycline-free group; P<.0001>
- No difference between groups in symptomatic left ventricular systolic dysfunction (1% vs 0%, respectively).
- Neither of the NACT regimens is widely used today.
- Open-label design.