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Between June and July8, patients were enrolled. Indue to futility to demonstrate noninferiority of L versus T, the L arm was closed, and patients free of disease were offered adjuvant T. At a protocol-specified analysis with a median follow-up of 4. L-treated patients experienced more diarrhea, cutaneous rash, and hepatic toxicity compared with T-treated patients.
The incidence of cardiac toxicity was low in all treatment arms. Adjuvant treatment that includes L did not significantly improve DFS compared with T alone and added toxicity. One year of adjuvant T remains standard of care.
The Data Supplement provides additional eligibility criteria. Study design. Design 1: neoadjuvant or adjuvant chemotherapy completed before randomization; anti-HER2 agents were given. Design 2: anthracycline component of adjuvant chemotherapy before randomization; taxanes were given concomitantly with anti-HER2 agents.
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