No other genomic test is as validated to predict likelihood of chemotherapy benefit across multiple patient types, regardless of nodal status.1-5
A solid body of evidence validates prediction of chemotherapy benefit
The Oncotype DX Breast Recurrence Score® test is the only genomic test with Level 1 evidence for prognosis and prediction of chemotherapy
benefit in patients with early-stage, hormone receptor-positive, invasive breast cancer.4,6-8
Clinical validation studies
In total, 4 validation studies—involving nearly 3,000 patients—have been performed. The studies showed that the Oncotype DX® test is4,6-8:
Strongly associated with the rate of distant recurrence
A low Recurrence Score® result indicates a significantly lower rate of distant recurrence and a lower likelihood of chemotherapy benefit6,7
Predictive for likelihood of benefit from chemotherapy
A high Recurrence Score® result indicates a higher rate of distant recurrence and predicts a significant benefit from chemotherapy4,8
The TAILORx + RxPONDER results elevate the Oncotype DX test to the next level of precision with the highest quality of evidence, giving you clear, meaningful results for more impactful conversations with patients about the magnitude of chemotherapy benefit.
Proven to help patients with a low Recurrence Score result avoid chemotherapy
Several separate studies, with a total of more than 63,000 patients, found that patients with a low Recurrence Score result may be effectively treated with hormonal therapy alone and safely spared chemotherapy.1,12-18
STANDARD OF CARE
With prospective outcomes
over 100,000 patients—including
over 12,000 node-positive
To be predictive of chemotherapy benefit in both node-positive and node-negative patients4,8
In multiple studies with consistent results (level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)4,8
Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373(21):2005-2014.
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.
Sparano JA, Gray RJ, Wood WC, et al. TAILORx: Phase III trial of chemoendocrine therapy versus endocrine therapy alone in hormone receptor-positive, HER2-negative, node-negative breast cancer and an intermediate prognosis 21-gene recurrence score. Presented at: ASCO Annual Meeting II; 2018.
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.
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.
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.
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.
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.
Kalinsky KM, Barlow WE, Gralow JR, et al. Distant-disease free interval in participants with 1-3 positive lymph nodes,
hormone receptor-positive and HER2-negative breast cancer with recurrence score < or = 25 randomized to endocrine
therapy +/- chemotherapy: SWOG S1007 (RxPONDER). Presented at: San Antonio Breast Cancer Symposium;
December 8, 2021. Abstract GS2-07
Kalinsky K, Barlow W, Meric-Bernstam F, et al. First results from a phase III randomized clinical trial of standard
adjuvant endocrine therapy (ET) +/- chemotherapy (CT) in patients (pts) with 1-3 positive nodes, hormone receptorpositive (HR+) and HER2-negative (HER2-) breast cancer (BC) with recurrence score (RS) <25: SWOG S1007 (RxPonder).
Oral presentation at: San Antonio Breast Cancer Symposium; December 2020. Abstract GS3-00.
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or
Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer. ClinicalTrials.gov. NCT01272037.
Roberts MC, Miller DP, Shak S, Petkov VI. Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database. Breast Cancer Res Treat. 2017;163(2):303-310.
Petkov VI, Miller DP, Howlader N, et al. Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study. NPJ Breast Cancer. 2016;2:16017.
Shak S, Petkov V, Miller DP, et al. Breast cancer specific mortality in patients with early-stage hormone receptor–positive invasive breast cancer and oncotype DX recurrence score results in the SEER database. Proceedings from
Quality Care Symposium; 2016.
Gluz O, Nitz UA, Christgen M, et al. West German Study Group phase III PlanB trial: first prospective outcome data for the 21-gene recurrence score assay and concordance of prognostic markers by central and local pathology
assessment. J Clin Oncol. 2016;34(20):2341-2349.
Gluz O, Nitz U, Christgen M, et al. Prognostic impact of 21 Gene Recurrence Score, IHC4, and central grade in high-risk HR+/HER2- early breast cancer (EBC): 5-year results of the prospective Phase III WSG PlanB trial. Presented at: ASCO
Annual Meeting I; 2016.
Stemmer SM, Steiner M, Rizel S, et al. Real-life analysis evaluating 1594 N0/Nmic breast cancer patients for whom treatment decisions incorporated the 21-gene recurrence score result: 5-year KM estimate for breast cancer specific
survival with recurrence score results ≤30 is >98%. Cancer Res. 2016;76(4 Suppl):P5-08-02.
Stemmer SM, Steiner M, Rizel S, et al. First prospectively-designed outcome study in estrogen receptor (ER)+ breast cancer (BC) patients (pts) with N1mi or 1-3 positive nodes in whom treatment decisions in clinical practice
incorporated the 21-gene recurrence score (RS) result. Ann Oncol. 2016;27(Suppl 6):VI44.
Nitz U, Gluz O, Christgen M, et al. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group
(WSG) PlanB trial. Breast Cancer Res Treat. 2017;165(3):573-583.
Stemmer SM, Steiner M, Rizel S, et al. Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry. NPJ Breast
Andre F, Ismaila N, Allison KH, et al. Biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer: ASCO guideline update. J Clin Oncol. 2022;40(16):1816-1837.
National Institute for Health and Care Excellence (NICE) Guidelines. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. Diagnostics guidance [DG34]. 2018.
Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(8):1194-1220.
Coates AS, Winer EP, Goldhirsch A, et al. Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2015. Ann Oncol. 2015;26(8):1533-1546.