TAILORx — Trial Assigning Individualized Options for Treatment (Rx)

Phase 3 · 2018 · Breast Cancer

Design

Recurrence Score 11-25 patients randomized to endocrine therapy alone vs chemotherapy plus endocrine therapy; low and high scores assigned by score.

Population

HR-positive, HER2-negative, axillary node-negative early breast cancer with 21-gene Oncotype DX Recurrence Score.

Primary Endpoint

invasive disease-free survival (iDFS), non-inferiority

Key Result

Endocrine therapy non-inferior to chemo-endocrine at RS 11-25 (9-yr iDFS 83.3% vs 84.3%); chemo benefit limited to some women <=50 with RS 16-25.

Guideline Impact

NCCN endorses 21-gene assay to guide chemotherapy in node-negative HR+/HER2- disease