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6 months vs 12 months of adjuvant trastuzumab in early breast cancer (PHARE): Final analysis of a multicentre, open-label, phase 3 randomised trial

The Lancet Jun 13, 2019

Pivot X, et al. – Researchers reported the planned final analysis of the PHARE trial—an open-label, phase 3, non-inferiority, randomized trial involving patients with HER2-positive early breast cancer that compared 6 vs 12 months of trastuzumab treatment concomitant with or following standard neoadjuvant or adjuvant chemotherapy—based on the prespecified number of occurring events. The study sample consisted of 3,384 patients with HER2-positive early breast cancer. The investigators did not observe any change in the cardiac safety comparison, and noted that only three additional cases in which the left ventricular ejection fraction decreased to < 50% in the 12-month group. Overall, PHARE did not demonstrate the non-inferiority of 6 vs 12 months of adjuvant trastuzumab. Thus, the authors suggested that adjuvant trastuzumab standard duration should remain 12 months.

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