Prospective Outcomes

Outcomes Table 

Power in numbers: Only Oncotype DX® Breast Recurrence Score has prospective and consistent outcomes data in over 50,000 patients

TAILORx Trial: First prospective outcomes providing Level 1A evidence. WSG PlanB Trial: Confirmation of the clinical utility of the Recurrence Score.
TAILORx
Less than 1% risk of distant recurrence at 5 years in patients with Recurrence Score® results < 11 who were treated with hormonal therapy alone
  • TAILORx prospective outcomes data showing > 99% free of distant recurrence at 5 years in patients with Recurrence Score® results < 11 are consistent with validation studies1-3
  • Patient population: Node-negative, ER-positive, HER2-negative disease (Arm A)
94% of high-risk node-negative patients with Recurrence Score results ≤ 11 who were treated with hormonal therapy alone were still alive and disease-free at 5 years
  • Level 1A evidence shows that patients with low Recurrence Score results (RS ≤ 11) can be safely spared chemotherapy
  • Patient population: Node-positive or clinically high-risk node-negative disease

 

Clalit Study: Additional confirmation in a prospective registry in 2,000+ patients. SEER Study: The largest molecularly characterized cohort of patients with prospective outcomes in Oncotype DX tested patients.
Clait SEER
Less than 1% distant recurrence rate at 5 years in patients with Recurrence Score results < 18
  • Registry study outcomes show that the Recurrence Score result identifies patients who can safely be spared the addition of chemotherapy
  • Patient population: Node-negative or micrometastatic disease
Less then 1% BCSM at 5 years in > 21,000 patients who received Recurrence Score results < 18
  • Outcomes from a large, real-world observational study show the Recurrence Score result accurately identifies patients who do well with hormonal therapy alone
  • Patient population: Node-negative, ER-positive, HER2-negative disease

 

SEER Node
For node-positive patients with Recurrence Score results < 18,
it is unlikely that adding chemotherapy will improve clinical outcomes

Multiple studies confirm that Recurrence Score results identify patients who can
safely and effectively be spared chemotherapy.
 

 

REFERENCES

1. Sparano et al. N Engl J Med. 2015.
2. Paik et al. J Clin Oncol. 2006.
3. Paik et al. N Engl J Med.. 2004.
4. Gluz et al. EBCC 2016.
5. Stemmer et al. SABCS 2015.
6. Petkov et al. NPJ Breast Cancer. 2016.
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