Oncotype DX® Breast Recurrence Score

48 Year-Old Female Patient

with 1.5 cm Tumor

Patient Details

1.5 cm
ER positive
PR positive
Positive (1-3)
Not Provided
Not Provided
Not Provided

Not Provided

Clinical Experience

Prognosis and Chemotherapy Benefit in Patients with 1-3 Positive Nodes

In the clinical validation study1, after 5 years of Tamoxifen therapy, patients with a Recurrence Score of 3 had an Average Rate of Distant Recurrence at 5 years of 7% with Tamoxifen alone (95% CI: 4%-14%) vs. 10% with Tamoxifen + Chemotherapy (95% CI: 6%-17%).

Breast Cancer Case Study

Quantitative hormone receptor analysis

The Oncotype DX assay uses RT-PCR to determine the RNA expression of the hormone receptor genes below. These results may differ from ER, PR, or HER2 results reported using other methods or reported by other laboratories.2 The ER, PR, and HER2 Scores are also included in the calculation of the Recurrence Score.

ER ScoreN/A

For ER positive breast cancer, the magnitude of tamoxifen benefit increases as the ER Score increases from 6.5 to ≥12.5.3 Please note: The Average Rate of Distant Recurrence reported on Slide 2 based on the Recurrence Score assumes 5 years of tamoxifen treatment and takes into account the magnitude of tamoxifen benefit indicated by the ER Score.

PR ScoreN/A

The ER Score positive/negative cut-off of 6.5 units and PR Score positive/negative cut-off of 5.5 units were validated from multiple studies. The standard deviation for both the ER Score and the PR Score is less than 0.5 units.4

HER2 ScoreN/A

The HER2 positive cut-off of 11.5 units, equivocal range from 10.7 to 11.4 units, and negative cut-off of <10.7 units were validated from concordance studies of 755 samples using the HercepTestTM assay (immunohistochemistry) and another study of 568 samples using the PathVysion® assay (FISH). The standard deviation for the HER2 score is less than 0.5 units.5


1. Albain et al.Lancet Oncol. 2010.
2. ER Score based on quantitative ESR1 expression (estrogen receptor); PR Score based on quantitative PGR expression (progesterone receptor).
3. Kim et al. J Clin Oncol. 2011.
4. Badve et al. J Clin Oncol. 2008.
5. Paik et al. ASCO 2005.

Disclaimer: These case studies are brought to you for educational purposes only and should not be interpreted as an endorsement of Genomic Health or its services by the submitting physician, or any other product or therapy. The information is sometimes related to interpretive diagnostic opinions of the treating physicians, and is not intended to represent the “standard of care.” The case studies reflect real life cases of patients who have used Oncotype DX, however they are individual results and results do vary. The examples are not necessarily representative of all of those who will use our clinical tests. Genomic Health does not endorse any of the contributors featured on this site.

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Positive (1-3)
Recurrence Score®3
ER ScoreN/A
PR ScoreN/A
HER2 ScoreN/A