Healthcare Professionals > Oncotype DX Breast Recurrence Score

Clinical evidence for the Oncotype DX Breast Recurrence Score® test in node-negative patients

The clinical validity and utility of the Oncotype DX Breast Recurrence Score® test in patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer have been established through extensive clinical research in over 85,000 patients.1-8

Prediction of chemotherapy benefit makes the Oncotype DX Breast Recurrence Score test unique

  • The Oncotype DX Breast Recurrence Score test was validated as prognostic of distant recurrence for node-negative, HR+ early stage breast cancer patients1
  • The Oncotype DX® test was uniquely validated to predict chemotherapy benefit in the 2-arm randomised clinical trial NSABP B-202,9 (interaction between Recurrence Score® result and benefit from chemotherapy p=0.0149).
  • The practice-changing TAILORx prospective randomised clinical trial refined former findings, enabling a more precise threshold for CT benefit.3,4,10

Establishing prediction of chemotherapy benefit with precision

Clinical evidence from the TAILORx and NSABP B-20 studies established that the Oncotype DX test can identify two groups of patients: those who may be spared chemotherapy and those who may substantially benefit from it.2,4,9

Patients with Recurrence Score results 0–25 do not benefit from the addition of chemotherapy to endocrine therapy2,4,9

~ 80% of the patients4,7,8

Patients with Recurrence Score results 26–100 significantly benefit from the addition of chemotherapy to endocrine therapy2,9

~ 20% of the patients4,7,8

TAILORx landmark practice-changing trial

The NSABP B-20 trial established that patients with Recurrence Score results 0-10 do not benefit from the addition of CT to ET and that patients with a Recurrence Score result 26-100 do benefit from the addition of CT9. The TAILORx trial was designed to determine whether ET was non-inferior to CT+ET in patients with Recurrence Score results 11-25.4,11

 

Real World Evidence

Real-world evidence is consistent with clinical studies. It confirms that the Oncotype DX test consistently identifies a minority of patients (15-20%) with Recurrence Score results 26-100 who derive substantial benefit from chemotherapy.

WHY CHOOSE THE ONCOTYPE DX BREAST RECURRENCE SCORE TEST?

The Oncotype DX Breast Recurrence Score test identifies the vast majority of women who may not benefit from the addition of chemotherapy to endocrine therapy and the important minority of women for whom chemotherapy may be life-saving.2,4,9

  • The only assay proven to predict chemotherapy benefit2
  • Independent predictor of chemotherapy benefit and patient outcomes2
  • Can help reduce over- and undertreatment4,14-18
  • Can help guide treatment decisions across age groups4
  • Consistent and large body of evidence across prospective randomised trials, validation studies and real-world evidence1-10

KEY STUDY DETAILS

  • NSABP B-14 Study:1 The first clinical validation of the Oncotype DX Breast Recurrence Score test, the NSABP B-14 study, demonstrated that the Recurrence Score result quantifies the risk of distant recurrence in node-negative patients. It showed that the 10-year rate of distant recurrence is significantly lower for patients with low Recurrence Score results compared to patients with higher scores.
  • NSABP B-20 Study:2,9 This study determined that the Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-negative patients: a low Recurrence Score result predicted little to no benefit from the addition of chemotherapy to endocrine therapy, while a high score predicted a larger benefit from chemotherapy.
  • TAILORx Study:3,4,10,11 The first prospective outcomes study providing Level 1A evidence for a multigene assay, the TAILORx Trial confirmed that, overall, patients with Recurrence Score results 11-25 do not benefit from the addition of chemotherapy to endocrine therapy and may be effectively and safely treated with hormonal therapy alone.

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