Outcomes Data

Oncotype DX: The Only Genomic Breast Cancer Test with Prospective Outcomes Data

Watershed TAILORx trial finds 99% of women with low Oncotype DX Recurrence Scores are free of breast cancer recurrence after five years of hormone therapy alone. Learn more about this historic study published in the New England Journal of Medicine.

A new analysis of TAILORx confirms the original, definitive conclusions reported previously with additional detail on clinical risk, focusing on patients with early-stage breast cancer who are age 50 years or younger. Read the analysis in the New England Journal of Medicine.

The publication in the Journal of the American Medical Association – Oncology by Sparano et al., described clinical outcomes for women with a high Recurrence Score result 26-100, who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone. Read the study in JAMA.

Journal of Clinical Oncology publishes prospective outcomes results from large international trial using Oncotype DX. Read the study in the Journal of Clinical Oncology.

Nature Partner Journals publish five-year outcomes results from SEER Registry demonstrating Oncotype DX accurately identifies early-stage breast cancer patients with excellent survival. Read the study in the Nature Partner Journal.

Published outcomes results from SEER Registries indicates that many node-positive breast cancer patients can avoid chemotherapy based on Oncotype DX results. Read the study in the journal Breast Cancer Research and Treatment.


The Oncotype DX Breast Recurrence Score is the only multi-gene breast cancer assay considered standard of care and incorporated into major international breast cancer treatment guidelines based on its proven ability to predict chemotherapy benefit for patients with early stage breast cancer.

Updated US guidelines, including NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®), support the use of the 21-gene assay (Oncotype DX Breast Recurrence Score test)1-3


The only NCCN® preferred multigene test for patients with HR+, HER2-, node-negative disease, with Category 1 evidence1,2

NCCN® recommendation to strongly consider for patients with HR+, HER2-, node-negative disease and tumors >0.5 cm1,2


Strongly recommended by ASCO to guide decisions on adjuvant chemotherapy in patients with ER+, HER2-, node-negative breast cancer3


The only multi-gene test with Level IA evidence incorporated in the Eighth Edition AJCC Cancer Staging Manual to downstage breast cancer patients.

* Also incorporated in international guidelines, including ESMO, St Gallen, NICE, and IQWiG.4-7
* NCCN is a registered trademark of the National Comprehensive Cancer Network; ASCO is a registered trademark of the American Society of Clinical Oncology. NCCN and ASCO do not endorse any therapy or product.

  1. Referenced with permission from the NCCN Guidelines® for Breast Cancer V.3.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed September 26, 2019. To view the most recent and complete version of the guideline, go online to
  2. Telli et al. J Natl Compr Cancer Netw. 2019.
  3. Andre et al. J Clin Oncol. 2019.
  4. Cardoso et al. Ann Oncol. 2019.
  5. Burstein et al. Ann Oncol. 2019.
  6. NICE Guidelines. Published December 2018.
  7. IQWiG press release. Published September 9, 2018.
Clinical Validation

A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, D Watson, T Park, W Hiller, ER Fisher, DL Wickerham, J Bryant, N Wolmark
N Engl J Med. 2004 Dec 30;351(27):2817-26.

Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
S Paik, G Tang, S Shak, C Kim, J Baker, W Kim, M Cronin, FL Baehner, D Watson, J Bryant, JP Costantino, C Geyer Jr., DL Wickerham, N Wolmark
J Clin Oncol. 2006 Aug 10;24(23):3726-34.

A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. 
LA Habel, S Shak, M Jacobs, A Capra, C Alexander, M Pho, J Baker, MG Walker, D Watson, J Hackett, N Blick, D Greenberg, L Fehrenbacher, B Langholz, CP Quesenberry
Breast Cancer Res. 2006;8(3):R25.

Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population.
Toi M, Iwata H, Yamanaka T, Masuda N, Ohno S, Nakamura S, Nakayama T, Kashiwaba M, Kamigaki S, Kuroi K; Japan Breast Cancer Research Group-Translational Research Group.
Cancer. 2010 Jul 1;116(13):3112-8.

Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S.
J Clin Oncol. 2010 Apr 10;28(11):1829-34.

Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, estrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomized trial.
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America.
Lancet Oncol. 2010 Jan;11(1):55-65.

Decision Impact

Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER1) node-negative breast cancer.
J. Albanell, A. Gonzalez, M. Ruiz-Borrego, et al.
Ann Oncol.

Impact of the 21-Gene Recurrence Score Assay Compared With Standard Clinicopathologic Guidelines in Adjuvant Therapy Selection for Node-Negative, Estrogen Receptor-Positive Breast Cancer.
Partin JF, Mamounas EP.
Annals of Surgical Oncology

The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy.
Geffen DB, Abu-Ghanem S, Sion-Vardy N, Braunstein R, Tokar M, Ariad S, Delgado B, Bayme M, Koretz M.
Ann Oncol.

Physician Survey of the Effect of the 21-Gene Recurrence Score Assay Results on Treatment Recommendations for Patients With Lymph Node–Positive, Estrogen Receptor–Positive Breast Cancer
Ruth Oratz, MD, FACP, Benjamin Kim, MD, MPhil, Calvin Chao, MD, Stanley Skrzypczak, MS, Caron Ory, RN, MSN, Roberto Bugarini, DStat, and Michael Broder, MD, FACOG
Journal of Oncology Practice 2011.

Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection.
Shelly S. Lo,*Patricia B. Mumby, ­John Norton, ­Karen Rychlik, ­Jeffrey Smerage, ­Joseph Kash, ­Helen K. Chew, ­Ellen R. Gaynor, ­Daniel F. Hayes, ­Andrew Epstein, ­and Kathy S. Albain

Association Between the 21-Gene Recurrence Score Assay and Risk of Locoregional Recurrence in Node-Negative, Estrogen Receptor–Positive Breast Cancer: Results From NSABP B-14 and NSABP B-20. 
Eleftherios P. Mamounas,*­Gong Tang, ­Bernard Fisher, ­Soonmyung Paik, ­Steven Shak, ­Joseph P. Costantino, ­Drew Watson, ­Charles E. Geyer Jr, ­D. Lawrence Wickerham, ­and Norman Wolmark

The influence of a gene expression profile on breast cancer decisions.
Henry L, Stojadinovic A, Swain SM et al.
Journal of Surgical Oncology:319–323.

Does Oncotype DX recurrence score affect management of patients with early –stage breast cancer? 
Asad J, Jacobson A, Estabrook A et al.
Am J Manag Care. 2008;American Journal of Surgery:527–529.

Low Recurrence Score by the Oncotype DX Breast Cancer Assay Rarely Results in Recommendation for or Administration of Chemotherapy: A Pooled Analysis
P Hall, S Skrzypczak, G Palmer
Abstract #2601: Poster Session

Impact of a Commercial Reference Laboratory Test Recurrence Score on Decision Making in Early-Stage Breast Cancer
R Oratz, D Paul, AL Cohn, SM Sedlacek

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik

A Retrospective Analysis of the Impact of Oncotype DX Low Recurrence Score Results on Treatment Decisions in a Single Academic Breast Cancer Center
H Liang, AM Brufsky, BB Lembersky, P Rastogi, VG Vogel
Abstract #2061 : Poster Session

Evaluation of Practice Patterns in the Treatment of Node-Negative, Hormone-Receptor Positive Breast Cancer Patients with the Use of the Oncotype DX Assay at the University of Pennsylvania
C Erb, KR Fox, M Patel, K Hook, A DeMichele, C Kaplan, S Domchek
Abstract #3082 : Poster Session

Prospective Multi-Center Study of the Impact of the 21-Gene Recurrence Score (RS) Assay on Medical Oncologist (MO) and Patient (PT) Adjuvant Breast Cancer (BC) Treatment Selection
SS Lo, J Norton, PB Mumby, J Smerage, J Kash, HK Chew, D Hayes, A Epstein, KS Albain
Abstract #577 : Poster Session

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers
R Simon
J Clin Oncol. 2005;23(29):7332-7341.

Impact of Oncotype DX™ on Decision Making in Breast Cancer Clinical Practice
R Oratz, D Paul, A Cohn, S Sedlacek
Abstract #2049 : Poster Session

Prospective Multi-Center Study of the Impact of the 21-Gene Recurrence Score Assay on Patient Satisfaction, Anxiety and Decisional Conflict for Adjuvant Breast Cancer Treatment Selection
PB Mumby, SS Lo, J Norton, J Smerage, K Joseph, HK Chew, D Hayes, KS Albain
Abstract #1092 : Poster Session

Neoadjuvant Treatment
Health Economics
Platform Technology
Assay Development
Additional Oncotype DX Assay Related Articles

The Role of the Breast Cancer Surgeon in Personalized Cancer Care: Clinical Utility of the 21-Gene Assay
Laronga C, Harness JK, Dixon M, Borgen P
Am J Surg. 2012.

Estrogen Receptor (ESR1) mRNA Expression and Benefit From Tamoxifen in the Treatment and Prevention of Estrogen Receptor–Positive Breast Cancer
Kim C, Tang G, Pogue-Geile KL, et al
J Clin Oncol. 2011.

Strategies for Subtypes—Dealing with the Diversity of Breast Cancer: Highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011
Goldhirsch A, Wood WC, Coates AS, et al
Ann Oncol. 2011.

Human Epidermal Growth Factor Receptor 2 Assessment in a Case-Control Study: Comparison of Fluorescence In Situ Hybridization and Quantitative Reverse Transcription Polymerase Chain Reaction Performed by Central Laboratories
Baehner FL, Achacoso N, Maddala T, et al
J Clin Oncol. 2010.

Comparison of the Prognostic and Predictive Utilities of the 21-Gene Recurrence Score Assay and Adjuvant! for Women with Node-Negative, ER-Positive Breast Cancer: Results from NSABP B-14 and NSABP B-20
Tang G, Shak S, Paik S, et al
Breast Cancer Res Treat. 2010.

Problems and Solutions in the Evaluation of Hormone Receptors in Breast Cancer
Allred DC
J Clin Oncol. 2008.

Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory
Badve SS, Baehner FL, Gray RP, et al
J Clin Oncol. 2008.

Development of the 21-Gene Assay and Its Application in Clinical Practice and Clinical Trials
Sparano JA, Paik S
J Clin Oncol. 2008.

American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
Harris L, Fritsche H, Mennel R, et al
J Clin Oncol. 2007.

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers
Simon R
J Clin Oncol. 2005.

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