Rationale and trial design of NATALEE: a Phase III trial of adjuvant ribociclib + endocrine therapy <i>versus</i> endocrine therapy alone in patients with HR+/HER2- early breast cancer.

16 , 41 While abemaciclib has also shown significant OS benefit in combination with fulvestrant in the second-line setting in MONARCH-2, 42 an interim OS analysis in MONARCH-3 has yet to show a statistically significant benefit of abemaciclib + NSAI versus NSAI alone in the first-line setting; however, interim results suggested a positive trend. 43 Neither Phase III trial evaluating palbociclib in ABC (PALOMA-3 and PALOMA-2) demonstrated a statistically significant improvement in OS. 44 , 45 ET is the current standard of care for patients with HR+/HER2− EBC.

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