Introduction
cancer
CANCER, INVASIVE CANCER
Patient-reported outcomes (PROs) are increasingly recognized as essential components of clinical researchPROs are particularly important in cancer therapy de-escalation trials for several reasons. As these trials can rarely be blinded, substantive patient buy-in and shared decision-making are essential. Patients may have second thoughts about forgoing standard therapies and this uncertainty may influence future treatment decisions. Fears about oncologic safety may also impact well-being and, in turn, clinical outcomes. When oncologic outcomes are noninferior to the standard of care, the impact of de-escalation on health-related quality of life (HRQOL) is particularly meaningful.This article reports the first planned analysis of longitudinal PROs for a prospective, multicenter clinical trial evaluating the omission of breast surgery for invasive cancers with exceptional response to neoadjuvant systemic therapy (NST). Trial feasibility has been described previously,