Historically, novel postneoadjuvant therapies for patients with early breast cancer have been assessed in multiyear trials. In an effort to address the unmet need of postneoadjuvant therapies in high-risk populations, the US Food and Drug Administration established guidelines for expediting the drug approval process by using pathologic complete response (pCR) as the end point. Previous randomized neoadjuvant trials have suggested that this end point may predict long-term outcome in patients with early-stage breast cancer.1
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Shyr Y, Shyr D. What Constitutes a Valid Surrogate End Point in Cancer Clinical Trials? JAMA Oncol. Published online July 23, 2020. doi:10.1001/jamaoncol.2020.1847
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