The Oncotype DX Breast Recurrence Score Test is Backed by Landmark Clinical Studies

Global Validation Studies for Patients with Early-Stage, ER+, HER2- Breast Cancer

Clinical validation studies are essential in the development of a genomic test. They help determine if the test is accurate by checking that the genes being analyzed actually relate to the presence or absence of disease.1 The Oncotype DX Breast Recurrence Score test has been validated in many such studies, showing that Recurrence Score results do correlate with risk of recurrence and chemotherapy benefit.2-12 The results from two recent, landmark studies can help patients make treatment decisions with more confidence:

TAILORx For Node-Negative Breast Cancer Patients

Is the largest ever breast cancer treatment trial identifying which node-negative patients can use hormonal therapy alone and can safely avoid the side-effects of chemotherapy.

What the study found:

  • That the vast majority of early-stage breast cancer patients can safely forgo chemotherapy.2
  • Women with low scores (Recurrence Score results 0-10) did not benefit from chemotherapy, and 99% of those patients did not have their breast cancer come back after 5 years when treated with hormonal therapy alone.11
  • Patients with Recurrence Score results less than or equal to 25 do not receive benefit from adding chemotherapy to their treatment plan.2

RxPONDER For Node-Positive Breast Cancer Patients

Is a treatment trial determining the benefit of chemotherapy in node-positive breast cancer patients with Recurrence Score results of 0 to 25.*

What the study found:

  • The majority of node-positive patients can safely forgo chemotherapy.13
  • Postmenopausal women with 1-3 positive nodes and a Recurrence Score result 0-25 can forgo chemotherapy.13

Learn more about what the Oncotype DX Test can Provide You

*Additional clinical data shows that women with node-positive breast cancer and Recurrence Score results greater than 25 benefit from adding chemotherapy to their treatment plan.14

REFERENCES
1 Regulation of Genomic Tests. genome.gov. https://www.genome.gov/10002335/regulation-of-genetictests/. Updated September 25, 2020. Accessed April 22, 2021.
2 Sparano et al. N Engl J Med. 2018.
3 Paik et al. J Clin Oncol. 2006.
4 Sparano et al. J Clin Oncol. 2006.
5 Albain et al. Lancet Oncol. 2010.
6 Geyer et al. npj Breast Cancer. 2018.
7 Paik et al. N Engl J Med. 2004.
8 Habel et al. Breast Cancer Res. 2006.
9 Dowsett et al. J Clin Oncol. 2010.
10 Toi et al. Cancer. 2010.
11 Sparano et al. N Engl J Med. 2015.
12 Sparano et al. JAMA Oncol. 2019.
13 Kalinsky, K. et al. Oral Presentation: [GS3-00]. San Antonio Breast Cancer Symposium; December 2020.
14 Albain et al. Lancet Oncol. 2010.