Clinical Evidence

A solid body of evidence validates prediction of chemotherapy benefit

It is the only genomic test to fulfill the criteria for 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 3000 patients—have been performed. The studies show that the Oncotype DX Breast Recurrence Score^® test is:^4,6-8

Strongly associated with the rate of distant recurrence

A low score indicating a significantly lower rate of distant recurrence and a lower likelihood of chemotherapy benefit^6,7

Predictive for likelihood of benefit from chemotherapy

A high score indicating a higher rate of distant recurrence and predicting a significant benefit from chemotherapy^4,8

Node-Negative	Node-positive
TAILORx Trial^1-4	RxPONDER Trial^5,9-11
10,273 patients Recurrence Score result <25 Identified 70% of women with no chemotherapy benefit who would have been overtreated View the landmark trial details View additional node-negative data	5083 patients Recurrence Score result <25 Postmenopausal women (1-3 +nodes) can forgo chemotherapy Premenopausal women (1-3 +nodes) modestly benefit from chemotherapy View trial details View additional node-positive data

TAILORx + RxPONDER results elevate the Oncotype DX Breast Recurrence Score 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.

STANDARD OF CARE

With prospective outcomes in over 100,000 patients – including over 12,000 node-positive patients^2,5,9,11-14

PROVEN

To be predictive of chemotherapy benefit in both node-positive and node negative patients^4,8

CLINICALLY VALIDATED

In multiple studies with consistent results (Level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)^4,8

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.^1,13,15-20

References
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 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 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.
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. The Lancet Oncology. 2010;11(1):55-65.
Kalinsky K, 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 = 25 randomized to endocrine therapy +/- chemotherapy: SWOG S1007 (RxPONDER). Oral Presentation at: San Antonio Breast Cancer Symposium; December 2021.
Kalinsky K, et al. [GS3-00]. 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 receptor-positive (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.
NIH Clinical Trials.gov: NCT01272037. Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer. 2022.
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.
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.
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 Cancer. 2017;3:32.
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 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 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 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%. Presented at: San Antonio Breast Cancer Symposium; 2015.
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. ESMO. 2016;1-3.

Treatment Determination

Therapy Selection

Testing And Treating

Understanding Your Diagnosis

A solid body of evidence validates prediction of chemotherapy benefit

Clinical validation studies

Strongly associated with the rate of distant recurrence

Predictive for likelihood of benefit from chemotherapy

TAILORx + RxPONDER results elevate the Oncotype DX Breast Recurrence Score 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

Use our online physician portal

Quick Links

Clinical Evidence

A solid body of evidence validates prediction of chemotherapy benefit

Clinical validation studies

Strongly associated with the rate of distant recurrence

Predictive for likelihood of benefit from chemotherapy

TAILORx + RxPONDER results elevate the Oncotype DX Breast Recurrence Score 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

Use our online physician portal

Have questions?

Quick Links

Follow Us

TAILORx + RxPONDER results elevate the Oncotype DX Breast Recurrence Score 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.