Personalised Genomic Testing
Oncotype DX Breast Recurrence Score® Test
The Oncotype DX Breast Recurrence Score® test is a personalised test performed on tumour tissue that estimates the risk of distant recurrence — and helps predict if patients may benefit from chemotherapy, regardless of nodal status.
Evidence-led Decisions
The only test proven to predict chemotherapy benefit
The Breast Recurrence Score® test helps predict chemotherapy benefit in patients with HR+, HER2- early-stage breast cancer, regardless of nodal status.
The Assay
How the Breast Recurrence Score assay works
- Uses a patient’s unique tumor sample
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Assesses the expression of 21 genes
- 16 cancer-related genes
- 5 reference genes
- Uses reverse transcriptase-polymerase chain reaction (RT-PCR) to analyze tumor RNA
- Uses tissue obtained at the time of core biopsy or surgical excision
Personalised Results
Provides a genomic assessment
- Includes the estimated risk of distant recurrence with endocrine therapy alone
- Helps predict the benefit of adding chemotherapy to endocrine therapy
Additional Insight
Determines quantitative single-gene scores
- Quantitative estrogen receptor (ER) score helps assess the magnitude of hormonal therapy benefit
- Provides additional supporting information, such as progesterone receptor (PR) and human epidermal growth factor receptor 2 gene (HER2) scores
References
- 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.
- 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.
- 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, estrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55-65.
- Dowsett M, Cuzick J, Wale C, et al. 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. J Clin Oncol. 2010;28(11):1829-1834.
- 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.
- 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.
- Kalinsky K, et al. Updated results from a phase 3 randomized clinical trial in participants (pts) with 1-3 positive lymph nodes, hormone receptor-positive (HR+) and HER2-negative breast cancer with recurrence score of 25 or less: SWOG S1007. Presented at SABCS, Dec. 2021; Abstract GS2-07.
- Sparano JA, Crager M, Gray RJ, et al. Clinical and genomic risk for late breast cancer recurrence and survival. NEJM Evid. 2024;3(8):EVIDoa2300267.
- Referenced with permission from the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) for Breast Cancer V.4.2025. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed April 28, 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.
- Jakubowski DM, Bailey H, Abran J, et al. Molecular characterization of breast cancer needle core biopsy specimens by the 21-gene Breast Recurrence Score test. J Surg Oncol. 2020;122(4):611-618.
- Kim C, Tang G, Pogue-Geile KL, et al. Estrogen receptor (ESR1) mRNA expression and benefit from tamoxifen in the treatment and prevention of estrogen receptor-positive breast cancer. J Clin Oncol. 2011;29(31):4160-4167.
- Badve S, et al. Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry and Reverse-Transcription Polymerase Chain Reaction. J Clin Oncol. 2008;26(15):2473–2481.
- Baehner FL, et al. Quantitative RT-PCR analysis of ER, PR, and HER2 expression in FFPE tumor tissue: Comparison with IHC and FISH. J Clin Oncol. 2010;28(15_suppl):10572. doi: 10.1200/JCO.2009.24.8211
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.
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