# MINDACT

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

## TL;DR

MINDACT showed that women whose early breast cancer looked high-risk to doctors but low-risk on the 70-gene MammaPrint test could skip chemotherapy: those who did met the trial's prespecified safety threshold, and about 46% of clinically high-risk women could avoid chemotherapy. Women aged 50 or under may still gain from it.

## Summary

Among 6,693 women, 1,550 had high clinical risk but low genomic risk by MammaPrint; those randomised to no chemotherapy had 5-year distant metastasis-free survival of 94.7% (NEJM 2016), meeting the prespecified threshold, with a 1.5 percentage point difference versus chemotherapy that was not statistically significant. The 8-year update (Lancet Oncology 2021) confirmed the finding, with a suggestion of chemotherapy benefit in women aged 50 or under. About 46% of clinically high-risk women could avoid chemotherapy.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Registry id: NCT00433589
- Phase: 3
- Setting: Early breast cancer with discordant clinical and genomic (MammaPrint) risk: chemotherapy or not according to genomic risk
- Sponsor: EORTC / Breast International Group
- Enrolled: 6693
- Result: 5-year distant metastasis-free survival 94.7% without chemotherapy in clinical-high, genomic-low risk women.
- Outcomes: 5-year distant metastasis-free survival, clinical-high / genomic-low risk, no chemotherapy: No chemotherapy (genomic risk) 94.7%
- Replication: TAILORx and RxPONDER reached parallel conclusions with the 21-gene Oncotype DX assay.

## Sources

- ClinicalTrials.gov NCT00433589: https://clinicaltrials.gov/study/NCT00433589
- MINDACT (NEJM 2016): https://doi.org/10.1056/NEJMoa1602253
- 8-year update (Lancet Oncol 2021): https://doi.org/10.1016/S1470-2045(21)00007-3

## 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/)
- companies: [Agendia](https://onco.cc/companies/agendia/), [Breast International Group (BIG)](https://onco.cc/companies/big/), [EORTC](https://onco.cc/companies/curie-nki-eortc/)
- key papers: [70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age](https://onco.cc/key-papers/paper-piccart-lancet-oncol/), [70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer](https://onco.cc/key-papers/paper-cardoso-n-engl-j-med/), [High concordance of protein (by IHC), gene (by FISH; HER2 only), and microarray readout (by TargetPrint) of ER, PgR, and HER2: results from the EORTC 10041/BIG 03-04 MINDACT trial](https://onco.cc/key-papers/paper-mindact-ann-oncol-2014/)
- terms: [Enrichment and biomarker-stratified designs](https://onco.cc/terms/biomarker-stratified-design/), [Pre-specified vs post-hoc analysis](https://onco.cc/terms/prespecified-vs-post-hoc/)

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