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Xichun Hu

Fudan University Shanghai Cancer Center

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SEP 11, 2026 · JOURNAL ARTICLE

Trastuzumab Botidotin Versus Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2–Positive Advanced Breast Cancer: A Phase III, Open-Label, Randomized Controlled Trial

Journal of Clinical Oncology

Phase 3 RCT with rigorous design (BICR-assessed primary endpoint, blinded review, 1:1 randomization) showing statistically significant and clinically meaningful PFS improvement (HR 0.39, p<.0001) meeting prespecified superiority boundary, though OS remains immature.

Strong EvidenceXichun Hu Jian Zhang Cancer Treatment and Pharmacology

Reported

Median PFS, trastuzumab botidotin11.1 months

Median PFS, trastuzumab emtansine4.4 months

Hazard ratio (PFS)0.39

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