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Node-Negative in Clinical Utility

Testing Core Biopsy Specimens

The COVID-19 pandemic has had a life-altering effect on the lives of the general population, but most notably health care providers and those with a diagnosis of cancer. We are all aware that in order to optimize provider, hospital, and clinic delivery of care, decisions are being made that are resulting in the postponement of both screening and diagnostic oncology services as well as elective surgery.

  • Our Oncotype DX® tests remain readily available and our laboratory continues to operate.
  • Core biopsies are the initial diagnostic procedure of choice for breast masses identified by physical exam or by imaging techniques.
  • The Oncotype DX test process was optimized to require only small amounts of tumor tissue and can be performed on a core biopsy of the breast cancer in lieu of the final resection specimen.
  • Guidance from the COVID-19 Pandemic Breast Cancer Consortium* references that a low-risk Recurrence Score® result from a core biopsy may be used to treat patients with Stage 1 or 2 disease, including N+ (1-3), with endocrine therapy alone when delaying surgery.a
  • View the new data on the molecular characterization of breast cancer needle core biopsy specimens by the 21‐gene Breast Recurrence Score test.
    Learn more about the COVID-19 Consortium recommendations for breast cancer treatment.
    Read a case study about "A 62-Year-Old Woman with Early Breast Cancer during the Covid-19 Pandemic" from the New England Journal of Medicine.

    Managing Breast Cancer During the COVID-19 Pandemic with the Oncotype DX Breast Recurrence Score Test

    Featuring speakers Christy Russell, MD (Sr. Medical Director, US Oncology) and Rick Baehner, MD (Chief Medical Officer, Precision Oncology)


    a. The COVID-19 Pandemic Breast Cancer Consortium. “COVID-19 Recommendations for Prioritization, Treatment and Triage of Breast Cancer Patients During the COVID-19 Pandemic.” The American Society of Breast Surgeons. Posted online April 7, 2020; Accessed April 9, 2020: https://www.breastsurgeons.org.
    * Includes representatives from ASBrS, NAPBC, NCCN, CoC, ACR

    Node-negative cancer

    Whether patients have node-negative or node-positive breast cancer, the Breast Recurrence Score test is both prognostic and predictive – providing both important prognostic information about the estimated risk of distant recurrence and the likelihood of adjuvant chemotherapy benefit.1-6

    Learn more about the study results:

    Prognostic Clinical Trial Results:
    Predictive Clinical Trial Results:
    Predictive Clinical Trial Results:

    Not all patients benefit from chemotherapy1

    The Oncotype DX Breast Recurrence Score test reveals individual tumor biology based on measuring the expression of 16 cancer genes and 5 reference genes.2,3

    The only multigene assay with both prognostic and predictive validation studies2-5

      Prognostic: The ability to use biomarkers to inform about a likely clinical outcome.
      Predictive: The ability to predict the response to a specific treatment (ie, chemotherapy benefit).

    Node-Negative Predictive Clinical Trial Results


    Node-Negative Predictive Clinical Trial Results

    Only the Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-negative patients.2

    NSABP B-20 Study: Low Recurrence Score

    NSABP B-20 Study: Low Recurrence Score result predicted little to no benefit from chemotherapy

    Low Recurrence Score graph Intermediate Recurrence Score graph

    NSABP B-20 Study: High Recurrence Score

    NSABP B-20 Study: High Recurrence Score result predicted large benefit from chemotherapy

    Prospective analysis of archived tissue from 651 patients with ER-positive, node-negative, invasive breast cancer treated with tamoxifen or tamoxifen plus CMF/MF. Approximately 45% of the patients were < 50 years of age, two-thirds of tumors were ≤ 2.0 cm in size, and 16% of tumors were progesterone receptor-negative.2

    High Recurrence Score graph

    Node-Negative Prognostic Clinical Trial Results

    The Recurrence Score result is directly associated with the rate of distant recurrence.1, 4

    NSABP B-14 Study

    NSABP B-14 Study

    10-year rate of distant recurrence was significantly lower for patients with low Recurrence Score results compared to high results


    Low Intermediate High Risk graph
    Low Recurrence Score result High Recurrence Score result

    Prospective analysis of archived tissue from 668 stage I or II patients with estrogen receptor (ER)-positive, node-negative, invasive breast cancer treated with tamoxifen. Twenty-nine percent of patients were < 50 years of age, and 62% had tumors that were ≤ 2.0 cm in size. The majority of patients (51%) in this study had low Recurrence Score results.1

    Only the Oncotype DX Breast Recurrence Score test is:


    STANDARD OF CARE

    icon fast
    with prospective outcomes in over 96,000 patients4-6,19-21 - including over 12,000 node-positive patients4-6*

    PROVEN

    icon comprehensive
    to be predictive of chemotherapy benefit in both node-positive and node-negative patients3,22

    CLINICALLY VALIDATED

    icon actionable
    in multiple studies with consistent results (Level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)3,22

    REFERENCES

    1. Nitz et al. Breast Cancer Res Treat. 2017.
    2. Roberts et al. Breast Cancer Res Treat. 2017.
    3. Stemmer et al. npj Breast Cancer. 2017; 3:32.
    4. Kalinsky, K et al. Oral Presentation: [GS3-00]. San Antonio Breast Cancer Symposium; December 2020.
    5. Stemmer et al. npj Breast Cancer Res Treat. 2017; 3:33.
    6. Sparano et al. N Engl J Med. 2018.
    7. Albain et al. Lancet Oncol. 2010.
    8. Sparano et al. N Engl J Med. 2015.

    *American Society of Clinical Oncology (ASCO) and ASCO are registered trademarks of ASCO; National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN. ASCO and NCCN do not endorse any product or therapy

    Making cancer care smarter.®