Trial reportThe New England journal of medicine2015
Prospective Validation of a 21-Gene Expression Assay in Breast Cancer.
Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 606 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment:The TAILORx Trial
LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer
French Prospective Real-life Evaluation of the Endopredict® Genomic Signature for HR-positive,HER2-negative Early Breast Cancer
Who cites it
606 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- Symptom clusters and their temporal patterns in breast cancer patients undergoing chemotherapy: a systematic review of cross-sectional and longitudinal studies.Frontiers in oncology · 2026Pooled it
- SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- Clinical and Genomic Risk for Late Breast Cancer Recurrence and Survival.NEJM evidence · 2024Pooled it
- SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (2022).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023Pooled it
- Evolution of Breast Cancer Recurrence Risk Prediction: A Systematic Review of Statistical and Machine Learning-Based Models.JCO clinical cancer informatics · 2023Pooled it
- A risk-based subgroup analysis of the effect of adjuvant S-1 in estrogen receptor-positive, HER2-negative early breast cancer.Breast cancer research and treatment · 2023Trial
- Phase III study of long-term prognosis of estrogen receptor-positive early breast cancer treated with neoadjuvant endocrine therapy with/without adjuvant chemotherapy.Breast cancer research and treatment · 2023Trial
- Evaluation of the Sensitivity to Endocrine Therapy Index and 21-Gene Breast Recurrence Score in the SWOG S8814 Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Expanding the Staging Criteria for T1-2N0 Hormone-Receptor Positive Breast Cancer Patients Enrolled in TAILORx.Annals of surgical oncology · 2022Trial
- Sample size methods for evaluation of predictive biomarkers.Statistics in medicine · 2022Trial
- Trial
- IMPARTER, Phase 1 of an intervention to improve patients' understanding of gene expression profiling tests in breast cancer.Breast cancer research and treatment · 2022Trial
- Trial
- Cyclophosphamide-Free Adjuvant Chemotherapy for Ovarian Protection in Young Women With Breast Cancer: A Randomized Phase 3 Trial.Journal of the National Cancer Institute · 2021Trial
- Oncotype DX: Clinical Utility, Evidence, and Future Trends in Personalized Breast Cancer Management.International journal of cancer · 2026Review
- Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways.Clinical pharmacology and therapeutics · 2026Review
- Multi-omic Profiling of Recurrence Risk Across Breast Cancer Subtypes.medRxiv : the preprint server for health sciences · 2026Article
- Clinician- and facility-level factors associated with chemotherapy dose reductions in stages I-IIIA breast cancer.Journal of the National Cancer Institute · 2026Article
- The Sig27 multigene stratifies breast cancer fatality risk via reflecting tumor-associated immune suppressive features.Translational oncology · 2026Article
- Clinical Significance of Tumor Invasion Gene Profiling in Early-Stage Hormone Receptor-Positive Breast Cancer: A Cross-Sectional Study.Health science reports · 2026Article
546 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
31 authors.
Funding
Abstract
backgroundPrior studies with the use of a prospective-retrospective design including archival tumor samples have shown that gene-expression assays provide clinically useful prognostic information. However, a prospectively conducted study in a uniformly treated population provides the highest level of evidence supporting the clinical validity and usefulness of a biomarker.
methodsWe performed a prospective trial involving women with hormone-receptor-positive, human epidermal growth factor receptor type 2 (HER2)-negative, axillary node-negative breast cancer with tumors of 1.1 to 5.0 cm in the greatest dimension (or 0.6 to 1.0 cm in the greatest dimension and intermediate or high tumor grade) who met established guidelines for the consideration of adjuvant chemotherapy on the basis of clinicopathologic features. A reverse-transcriptase-polymerase-chain-reaction assay of 21 genes was performed on the paraffin-embedded tumor tissue, and the results were used to calculate a score indicating the risk of breast-cancer recurrence; patients were assigned to receive endocrine therapy without chemotherapy if they had a recurrence score of 0 to 10, indicating a very low risk of recurrence (on a scale of 0 to 100, with higher scores indicating a greater risk of recurrence).
resultsOf the 10,253 eligible women enrolled, 1626 women (15.9%) who had a recurrence score of 0 to 10 were assigned to receive endocrine therapy alone without chemotherapy. At 5 years, in this patient population, the rate of invasive disease-free survival was 93.8% (95% confidence interval [CI], 92.4 to 94.9), the rate of freedom from recurrence of breast cancer at a distant site was 99.3% (95% CI, 98.7 to 99.6), the rate of freedom from recurrence of breast cancer at a distant or local-regional site was 98.7% (95% CI, 97.9 to 99.2), and the rate of overall survival was 98.0% (95% CI, 97.1 to 98.6).
conclusionsAmong patients with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who met established guidelines for the recommendation of adjuvant chemotherapy on the basis of clinicopathologic features, those with tumors that had a favorable gene-expression profile had very low rates of recurrence at 5 years with endocrine therapy alone. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00310180.).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.