Landmark TAILORx Results
The long-awaited results of the Trial Assigning IndividuaLized Options for Treatment (TAILORx) definitively identified a vast majority of women with early stage breast cancer who will receive no benefit from chemotherapy, and the minority for whom chemotherapy can be life-saving.
The Oncotype DX Breast Recurrence Score test provides a genomic-based, comprehensive, individualized risk assessment for certain women with early-stage invasive breast cancer. The test provides valuable information you can use to personalize a treatment plan specifically for each patient’s situation—including risk of distant recurrence, the benefit from chemotherapy and whether your patient can be treated effectively with hormonal therapy alone.1-6
ASCO®, NCCN®, and ESMO Guidelines, St. Gallen Consensus, and NICE Diagnostic Guidance*
Included in all major breast cancer treatment guidelines
The Oncotype DX Breast Recurrence Score test is incorporated in clinical guidelines of organizations including the American Society of Clinical Oncology (ASCO®), the National Comprehensive Cancer Network (NCCN®), the St. Gallen Consensus panel, the National Institute for Health Care Excellence (NICE), the European Society for Medical Oncology (ESMO) and the German Association of Gynecological Oncology (AGO).7-12*
How it works
The Breast Recurrence Score test is proven to predict the likely benefit of chemotherapy2, 3—as well as the risk of distant recurrence1, 4—for patients who are newly diagnosed with early-stage invasive breast cancer. Eligible patients are diagnosed with early stage, ER+, HER2- breast cancer with either node-negative or node-positive disease. The test uses RT-PCR to measure the expression of 21 genes: 16 cancer-related genes and five reference genes - in a tumour sample after it has been removed by surgery or biopsy.
The Oncotype DX Breast Recurrence Score: Predictive and Prognostic Results
By testing eligible patients after surgery, but before you discuss their treatment plans, you can make recommendations with increased insight and confidence.
The Breast Recurrence Score report: Informative for both clinicians and patients
The results are presented as a quantitative score, based on a continuous scale from 0-100. The score reflects individual tumour biology—the higher the score, the higher the risk of distant recurrence and the higher the likelihood of chemotherapy benefit are for that patient.2 The Breast Recurrence Score result can serve as a reference point for all members of the treatment team and can make discussing treatment options with your patients easier and more efficient.
The Breast Recurrence Score report also provides a quantitative ER score by RT-PCR to help assess the magnitude of hormonal therapy benefit13 and other supporting information (such as PR and HER2 scores). The test can provide insight into specific tumour biology, risk assessment and can inform treatment options.
Learn more about the results and see sample reports.
Excellent patient outcomes
Several large, independently run, international studies—including more than 63,000 patients15-23—found that the Breast Recurrence Score test is accurately associated with patient outcomes, including risk of distant recurrence and breast cancer survival. In addition, studies show that approximately 99% of node-negative patients with low Breast Recurrence Score results who were primarily treated using hormonal therapy alone (without chemotherapy) were distant recurrence-free after five years.14, 18 Get more details about these and other clinical studies regarding the Breast Recurrence Score test.
Node-negative and node-positive 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:
Node-Negative Prognostic Clinical Trial Results
The Recurrence Score result is directly associated with the rate of distant recurrence.1, 4
NSABP B-14: 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 tumours that were ≤ 2.0 cm in size. The majority of patients (51%) in this study had low Recurrence Score results.1
Node-Negative Predictive Clinical Trial Results
The Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-negative patients.2 The Oncotype DX Breast Recurrence Score test is the only test with published data supporting prediction of chemotherapy benefit.
NSABP B-20 Study
Low Recurrence Score result predicted little to no benefit from chemotherapy
NSABP B-20 Study
High Recurrence Score result predicted large benefit from chemotherapy
NSABP B-20: 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 tumours were ≤ 2.0 cm in size, and 16% of tumours were progesterone receptor-negative.2
Node-Positive Prognostic Clinical Trial Results
The Oncotype DX Breast Recurrence Score test provides important prognostic information about the estimated risk of distant recurrence for node-positive patients.4
TransATAC: Prospective analysis of archived tissue from 1,231 post-menopausal patients with invasive breast cancer treated with tamoxifen or an aromatase inhibitor, of whom 1,178 were estrogen receptor-positive and either node-negative or node-positive. Of 306 node-positive patients, 79% had 1-3 positive nodes, 21% had ≥ 4 positive nodes, and 4% had unknown nodal status. The mean age was 64 years, and 67% of tumours were ≤ 2.0 cm in size. 4
Node-Positive Predictive Clinical Trial Results
The Oncotype DX Breast Recurrence Score test predicts the likelihood of chemotherapy benefit for node-positive patients.3 The Oncotype DX Breast Recurrence Score test is the only test with published data supporting prediction of chemotherapy benefit.
SWOG 8814 Study
Low Recurrence Score results predicted little to no benefit from chemotherapy
SWOG 8814 Study
High Recurrence Score results predicted large benefit from chemotherapy
SWOG 8814: Prospective analysis of archived tissue from 367 post-menopausal, hormone receptor-positive, node-positive patients with invasive breast cancer treated with tamoxifen or tamoxifen plus cyclophosphamide/doxorubicin/fluorouracil (CAF). Approximately 62% had 1-3 positive nodes and the remainder had ≥4 positive nodes. Mean age was 60 years (range 42–81), 21% were progesterone receptor (PR)–negative, and 63% of tumours were 2 cm to 5 cm in size.3
For patients with large tumour to breast ratios who are interested in breast-conserving surgery, neoadjuvant therapy—such as chemotherapy or endocrine therapy—is an increasingly common consideration.
Research results have shown that the Breast Recurrence Score test is a predictor of response to neoadjuvant treatment and provides useful information to guide systemic treatment decisions:22-26
- Neoadjuvant studies are consistent with adjuvant studies that the Recurrence Score results correlate with benefits from adjuvant hormonal therapy and chemotherapy.
- Results indicate that lower Recurrence Score results are associated with greater clinical responses from neoadjuvant hormonal therapy.
- Findings suggest that higher Recurrence Score results are associated with greater clinical and pathologic responses from neoadjuvant chemotherapy.
Download a detailed summary of research results
Locoregional recurrence risk
A significant association was observed in studies between Breast Recurrence Score results and the risk for locoregional recurrence (LRR), in both node-negative and node-positive patients.27, 28 The results of these studies have potential clinical implications for locoregional therapy decisions for patients with node-negative or node-positive ER-positive breast cancer.
- The Recurrence Score result in node-negative patients was an independent, significant predictor of LRR along with age and type of initial treatment.
- In the node-positive setting, the Recurrence Score result is an independent predictor of LRR along with number of positive nodes and tumour size. These findings may have clinical implications regarding patient selection for post-mastectomy chest wall and regional nodal radiation therapy (XRT) and post-lumpectomy regional nodal XRT in node-positive, ER-positive patients treated with adjuvant chemo-endocrine therapy.
Late recurrence risk
ASCO® guidelines recommend 10 years of hormonal therapy for ER-positive breast cancer based on the aTTom and ATLAS studies.29, 31 The challenge facing physicians is identifying which patients are at higher risk of distant recurrence after five years of hormone therapy.
The Breast Recurrence Score test may identify patients who are at higher risk of distant recurrence beyond five years and might have greater benefit from extended hormonal therapy.32
- The association between quantitative ER and tamoxifen benefit has been shown in the landmark NSABP B-14 study.13
- The Recurrence Score result was significantly associated with prediction of late distant recurrence (years 5-15) in patients with higher quantitative ER expression (> 9.1).32
See the full study report