{"entity":{"id":"rxponder","kind":"trial","name":"RxPONDER (SWOG S1007)","aka":[],"tldr":"Postmenopausal women with a few positive lymph nodes and a low gene-test score can skip chemotherapy; premenopausal women still benefit from it.","summary":"RxPONDER, SWOG trial S1007, NCT01272037, sponsored by SWOG and the NCI and reported in 2020, showed that postmenopausal women with one to three positive lymph nodes and a low Oncotype DX recurrence score can skip chemotherapy, while premenopausal women still benefit from it. Among 5,083 women with HR-positive, HER2-negative disease and scores of 25 or below, chemotherapy added nothing to endocrine therapy in the 3,350 postmenopausal women but improved invasive disease-free survival in the 1,665 premenopausal women, a benefit possibly mediated by chemotherapy-induced ovarian suppression. OnCo links it to Oncotype DX, the ovarian function suppression term, the gene-assay-to-chemotherapy-omission pairing, Kathy S. Albain and Kevin Kalinsky. Whether ovarian suppression alone could replace chemotherapy in younger women is being tested in NRG-BR009, known as OFSET.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01272037","url":"https://clinicaltrials.gov/study/NCT01272037"}],"tags":[],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":["gene-expression-prognostic-assays","rna-seq"],"targets":[],"drugs":["oncotype-dx"],"companies":["swog"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kathy-albain","kevin-kalinsky"],"bottlenecks":[],"keyPapers":["paper-rxponder-n-engl-j-med-2021"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01272037","phase":"3","setting":"HR+/HER2- breast cancer with 1-3 positive nodes and recurrence score ≤25: endocrine therapy alone vs chemo-endocrine therapy","sponsor":"SWOG / NCI","result":"No chemo benefit postmenopausal; iDFS HR 0.60 with chemo premenopausal.","started":"2011-02-28","startedType":"actual","yearReported":2020,"enrolled":5018,"enrolledBasis":"registry","outcomes":[{"endpoint":"5-year iDFS, postmenopausal","primary":true,"unit":"%","arms":[{"name":"Endocrine alone","value":91.9},{"name":"Chemo-endocrine","value":91.3}],"hr":1.02,"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2108873"},{"endpoint":"5-year iDFS, premenopausal","primary":true,"unit":"%","arms":[{"name":"Endocrine alone","value":89},{"name":"Chemo-endocrine","value":93.9}],"hr":0.6,"ci":[0.43,0.83],"source":"https://doi.org/10.1056/NEJMoa2108873"}],"replication":"Consistent with TAILORx age interaction; the OFS-vs-chemotherapy question is being tested prospectively (NRG-BR009 / OFSET)."},"route":"/trials/rxponder/","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":"gene-expression-prognostic-assays","kind":"technology","name":"Gene-expression prognostic assays","route":"/technologies/gene-expression-prognostic-assays/"},{"id":"rna-seq","kind":"technology","name":"RNA sequencing & expression profiling","route":"/technologies/rna-seq/"}],"drug":[{"id":"oncotype-dx","kind":"drug","name":"Oncotype DX","route":"/drugs/oncotype-dx/"}],"company":[{"id":"swog","kind":"company","name":"SWOG Cancer Research Network","route":"/companies/swog/"}],"person":[{"id":"kathy-albain","kind":"person","name":"Kathy S. Albain","route":"/people/kathy-albain/"},{"id":"kevin-kalinsky","kind":"person","name":"Kevin Kalinsky","route":"/people/kevin-kalinsky/"}],"paper":[{"id":"paper-rxponder-n-engl-j-med-2021","kind":"paper","name":"21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer","route":"/key-papers/paper-rxponder-n-engl-j-med-2021/"}],"term":[{"id":"biomarker-stratified-design","kind":"term","name":"Enrichment and biomarker-stratified designs","route":"/terms/biomarker-stratified-design/"},{"id":"ovarian-function-suppression","kind":"term","name":"Ovarian function suppression (OFS)","route":"/terms/ovarian-function-suppression/"},{"id":"subgroup-analysis","kind":"term","name":"Subgroup analysis (forest plots)","route":"/terms/subgroup-analysis/"}],"pairing":[{"id":"genomic-assay-to-chemo-omission","kind":"pairing","name":"Gene-expression assay → chemotherapy omission","route":"/pairings/genomic-assay-to-chemo-omission/"}],"idea":[{"id":"idea-tr2-prospective-retrospective-path","kind":"idea","name":"A formal regulatory route for validating a biomarker on archived trial samples","route":"/ideas/idea-tr2-prospective-retrospective-path/"}],"institution":[{"id":"emory-winship","kind":"institution","name":"Winship Cancer Institute of Emory University","route":"/institutions/emory-winship/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}