{"entity":{"id":"mindact","kind":"trial","name":"MINDACT","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT00433589","url":"https://clinicaltrials.gov/study/NCT00433589"},{"label":"MINDACT (NEJM 2016)","url":"https://doi.org/10.1056/NEJMoa1602253"},{"label":"8-year update (Lancet Oncol 2021)","url":"https://doi.org/10.1016/S1470-2045(21)00007-3"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["rna-seq"],"targets":[],"drugs":["mammaprint"],"companies":["curie-nki-eortc","big"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-piccart-lancet-oncol","paper-cardoso-n-engl-j-med","paper-mindact-ann-oncol-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"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","result":"5-year distant metastasis-free survival 94.7% without chemotherapy in clinical-high, genomic-low risk women.","started":"2007-02","yearReported":2016,"enrolled":6693,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year distant metastasis-free survival, clinical-high / genomic-low risk, no chemotherapy","primary":true,"unit":"%","arms":[{"name":"No chemotherapy (genomic risk)","value":94.7}],"source":"https://doi.org/10.1056/NEJMoa1602253"}],"replication":"TAILORx and RxPONDER reached parallel conclusions with the 21-gene Oncotype DX assay."},"route":"/trials/mindact/","neighbours":{"cancer":[{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"}],"drug":[{"id":"mammaprint","kind":"drug","name":"MammaPrint (70-gene signature)","route":"/drugs/mammaprint/"}],"company":[{"id":"agendia","kind":"company","name":"Agendia","route":"/companies/agendia/"},{"id":"big","kind":"company","name":"Breast International Group (BIG)","route":"/companies/big/"},{"id":"curie-nki-eortc","kind":"company","name":"EORTC","route":"/companies/curie-nki-eortc/"}],"paper":[{"id":"paper-piccart-lancet-oncol","kind":"paper","name":"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","route":"/key-papers/paper-piccart-lancet-oncol/"},{"id":"paper-cardoso-n-engl-j-med","kind":"paper","name":"70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer","route":"/key-papers/paper-cardoso-n-engl-j-med/"},{"id":"paper-mindact-ann-oncol-2014","kind":"paper","name":"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","route":"/key-papers/paper-mindact-ann-oncol-2014/"}],"term":[{"id":"biomarker-stratified-design","kind":"term","name":"Enrichment and biomarker-stratified designs","route":"/terms/biomarker-stratified-design/"},{"id":"prespecified-vs-post-hoc","kind":"term","name":"Pre-specified vs post-hoc analysis","route":"/terms/prespecified-vs-post-hoc/"}]}}