# TAILORx

Source: https://onco.cc/trials/tailorx/  
OnCo record `tailorx` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed that most women with the commonest breast cancer can safely skip chemotherapy if a gene test says their risk is low or intermediate.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT00310180
- Phase: 3
- Setting: HR+/HER2-, node-negative early breast cancer with Oncotype DX recurrence score 11-25: endocrine therapy alone vs chemo-endocrine therapy
- Sponsor: ECOG-ACRIN / NCI
- Enrolled: 10273
- Result: 9-year iDFS 83.3% vs 84.3%; non-inferior.
- Outcomes: Invasive disease-free survival at 9 years (RS 11-25): Endocrine therapy alone 83.3% vs Chemo-endocrine therapy 84.3%, HR 1.08
- Replication: RxPONDER extended the finding to 1-3 positive nodes in postmenopausal women; MINDACT (MammaPrint) reached a similar conclusion with a different assay.

## Sources

- ClinicalTrials.gov NCT00310180: https://clinicaltrials.gov/study/NCT00310180

## Connected records

- cancers: [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [RNA sequencing & expression profiling](https://onco.cc/technologies/rna-seq/)
- drugs: [MammaPrint (70-gene signature)](https://onco.cc/drugs/mammaprint/), [Oncotype DX](https://onco.cc/drugs/oncotype-dx/)
- companies: [ECOG-ACRIN Cancer Research Group](https://onco.cc/companies/ecog-acrin/)
- people: [Joseph A. Sparano](https://onco.cc/people/joseph-sparano/), [Kathy S. Albain](https://onco.cc/people/kathy-albain/)
- key papers: [TAILORx: adjuvant chemotherapy guided by the 21-gene recurrence score in hormone receptor-positive, node-negative breast cancer](https://onco.cc/key-papers/paper-tailorx-nejm-2018/)
- pairings: [Gene-expression assay → chemotherapy omission](https://onco.cc/pairings/genomic-assay-to-chemo-omission/)
- ideas: [A formal regulatory route for validating a biomarker on archived trial samples](https://onco.cc/ideas/idea-tr2-prospective-retrospective-path/)
- terms: [Enrichment and biomarker-stratified designs](https://onco.cc/terms/biomarker-stratified-design/), [Intention-to-treat (ITT) and per-protocol analysis](https://onco.cc/terms/intention-to-treat/), [Non-inferiority margin and equivalence trials](https://onco.cc/terms/non-inferiority-margin/), [Non-inferiority trial](https://onco.cc/terms/non-inferiority/)
- institutions: [Montefiore Einstein Comprehensive Cancer Center](https://onco.cc/institutions/montefiore-einstein/)
- roadmaps: [Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs](https://onco.cc/roadmaps/chemotherapy-roadmap/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)

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JSON: https://onco.cc/api/v1/entities/tailorx.json