Showed that most women with the commonest breast cancer can safely skip chemotherapy if a gene test says their risk is low or intermediate.
TAILORx, trial NCT00310180 sponsored by ECOG-ACRIN and the NCI and reported in 2018, showed that most women with the commonest breast cancer can safely skip chemotherapy if the Oncotype DX gene test puts their recurrence risk in the low or intermediate range. Among 6,711 women with HR-positive, HER2-negative, node-negative disease and mid-range scores, endocrine therapy alone was non-inferior to chemotherapy plus endocrine therapy on invasive disease-free survival, although women aged fifty or under with scores of sixteen to twenty-five derived some chemotherapy benefit, and the trial spared chemotherapy for roughly seventy percent of eligible patients worldwide. RxPONDER extended the finding to node-positive postmenopausal women, and whether the age effect reflects ovarian suppression rather than chemotherapy is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
10,273 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Invasive disease-free survival at 9 years (RS 11-25)primary | Endocrine therapy alone | 3,399 | 83.3% | 1.08 (0.94 to 1.24) | - | link |
| Chemo-endocrine therapy | 3,312 | 84.3% |
Shares Kathy S. Albain, Gene-expression assay → chemotherapy omission, A formal regulatory route for validating a biomarker on archived trial samples, Enrichment and biomarker-stratified designs.
Shares MammaPrint (70-gene signature), Oncotype DX, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, RNA sequencing & expression profiling.
Shares MammaPrint (70-gene signature), Oncotype DX, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.
Shares MammaPrint (70-gene signature), Enrichment and biomarker-stratified designs, High-risk early HR-positive breast cancer, RNA sequencing & expression profiling.
Shares MammaPrint (70-gene signature), RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.
Shares Intention-to-treat (ITT) and per-protocol analysis, Non-inferiority margin and equivalence trials, Non-inferiority trial.
Shares Intention-to-treat (ITT) and per-protocol analysis, Non-inferiority margin and equivalence trials, Non-inferiority trial.
Shares Oncotype DX, RNA sequencing & expression profiling, HR-positive / HER2-negative breast cancer.