For providers
Clinical evidence

Rigorous, independent testing. Consistent results.

The Oncotype DX Breast Recurrence Score® test is validated to predict the likelihood of chemotherapy benefit in patients with node-negative or node-positive HR+, HER2- invasive breast cancer.1,2
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Level 1 evidence

The Oncotype DX Breast Recurrence Score test is the only test that provides level 1 evidence for prognosis of distant recurrence risk and prediction of chemotherapy benefit in patients with early-stage, HR+/HER2- invasive breast cancer, regardless of nodal status.1-5

Clinical validation studies

TAILORx trial

The Trial Assigning Individualized Options for Treatment (Rx), TAILORx, is the largest randomized, prospective, phase 3 trial assessing the ability of multi-gene assays to help inform adjuvant treatment strategies for women with early-stage breast cancer.6-11

Over 10,000 patients with node-negative (N0) disease across 7 countries around the world6,7
Demonstrated that the majority of patients with N0 disease may be able to safely forgo adjuvant chemotherapy6

RxPONDER trial

A Clinical Trial RX for Positive Node, Endocrine Responsive Breast Cancer, RxPONDER, expands the groundbreaking benefits to node-positive patients.12

Over 5,000 patients with node-positive (N1) disease
Demonstrated that the majority of postmenopausal patients with N1 breast cancer may be able to safely omit adjuvant chemotherapy from their treatment plan

SEER registry analysis

Long-term Surveillance, Epidemiology, and End Results (SEER)13

Over 6,000 patients
Demonstrated that the Oncotype DX Breast Recurrence Score test is prognostic for breast cancer-specific mortality in patients with invasive ductal carcinoma and invasive lobular breast cancer
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References

  1. Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55-65.
  2. Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726-3734.
  3. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817-2826.
  4. Dowsett M, Cuzick J, Wale C, et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in nodenegative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010;28(11):1829-1834.
  5. Referenced with permission from the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Breast Cancer V.3.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed March 31, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
  6. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379(2):111-121.
  7. National Library of Medicine. Hormone therapy with or without combination chemotherapy in treating women who have undergone surgery for node-negative breast cancer (the TAILORx trial) (TAILORx). Updated March 27, 2025. Accessed April 1, 2025. https://clinicaltrials.gov/study/NCT00310180
  8. Cardoso F, van’t Veer LJ, Bogaerts J, et al; MINDACT Investigators. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717-729.
  9. Sestak I, Martín M, Dubsky P, et al. Prediction of chemotherapy benefit by EndoPredict in patients with breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone. Breast Cancer Res Treat. 2019;176(2):377-386.
  10. Lænkholm A-V, Jensen M-B, Eriksen JO, et al. PAM50 risk of recurrence score predicts 10-year distant recurrence in a comprehensive Danish cohort of postmenopausal women allocated to 5 years of endocrine therapy for hormone receptor-positive early breast cancer. J Clin Oncol. 2018;36(8):735-740.
  11. Noordhoek I, Treuner K, Putter H, et al. Breast Cancer Index predicts extended endocrine benefit to individualize selection of patients with HR+ early-stage breast cancer for 10 years of endocrine therapy. Clin Cancer Res. 2021;27(1):311-319.
  12. Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med. 2021;385(25):2336-2347.
  13. Hortobagyi GN, Shak S, Sledge GW, et al. Breast cancer-specific mortality in patients with node-negative and node-positive breast cancer guided by the 21-gene assay: a SEER-genomic population-based study. Poster presented at: 41st Annual San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, TX. Poster P3-11-02.

Oncotype DX, Oncotype DX Breast Recurrence Score, Breast Recurrence Score, and Recurrence Score are registered trademarks of Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation. Exact Sciences is a registered trademark of Exact Sciences Corporation. All other trademarks are the properties of their respective owners.

The Oncotype DX Breast Recurrence Score test was developed, and the performance characteristics validated by Genomic Health, Inc., a wholly-owned subsidiary of Exact Sciences Corporation following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The Oncotype DX Breast Recurrence Score test is performed at the Genomic Health Redwood City clinical laboratory. Exact Sciences clinical laboratories are accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing. This test has not been cleared or approved by the US Food and Drug Administration or other notified regulatory authority.