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•
Primary end point, IDFS
, was defined as the time from randomization until the date of the first
occurrence of one of the following events:
•
Recurrence of ipsilateral invasive breast tumor,
•
Recurrence of ipsilateral locoregional invasive disease,
•
Distant disease recurrence,
•
Contralateral invasive breast cancer,
•
Death from any cause.
• This definition of invasive-disease–free survival (which excludes 2nd primary non breast cancer
as events) differs from the standardized definitions for efficacy end points (STEEP) definition
• 80% power to detect a
HR of 0.75
at a 5%, two-sided significance level.
• OP:
A 3-year rate of IDFS of
•
89.2% was assumed for the placebo group
, on the basis of the results of the Breast
Cancer International Research Group 006 trial
• 91.8% was assumed for the pertuzumab group,
• with approximately 379 events required for the primary analysis.
• The final (event-driven) OS analysis is planned to be conducted when 640 deaths have
occurred.
• Three interim overall survival analyses are planned, with the first reported in NEJM 2017 at an
adjusted two-sided significance level of 0.00001 to control the overall alpha level at 0.05.
ESTUDIO APHINITY: OBJETIVO PRIMARIO Y DISEÑO
von Minckwitz G, et al. N Engl J Med 2017;
377
:122–131.