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TAILORx Trial Results Aid in Assessing the Effect of Chemotherapy in Women With Early-Stage Breast Cancer

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On March 15, Genomic Health, Inc, was informed by the ECOG-ACRIN Cancer Research Group that the TAILORx trial, has achieved sufficient information to render a conclusion regarding the efficacy of chemotherapy in patients with early-stage breast cancer who have Oncotype DX recurrence score results of 11 to 25. This primary study group represents approximately 100,000 women diagnosed each year in the United States alone. ECOG-ACRIN will be submitting the results as a late-breaking abstract for presentation at an upcoming major medical meeting.

More About TAILORx

The TAILORx trial was independently designed and conducted by ECOG-ACRIN under the sponsorship of the National Cancer Institute (NCI). The primary objective of TAILORx is to more precisely determine the effect of chemotherapy, if any, for women with node-negative, hormone receptor–positive disease and Oncotype DX recurrence score results of 11 to 25.

TAILORx is the largest adjuvant breast cancer treatment trial ever conducted. It enrolled 10,273 women with early-stage breast cancer across approximately 1,200 sites in the United States and 5 additional countries. Investigators used the Oncotype DX test on every patient to quantify individual risk of recurrence and assign treatment to determine whether chemotherapy would be beneficial. Based on previous studies, TAILORx participants with recurrence score results less than 11 were treated with hormonal therapy alone, whereas those with recurrence score results greater than 25 were treated with chemotherapy plus hormonal therapy.

To more precisely define the effect of chemotherapy for women considered to be at intermediate risk for recurrence, more than 6,700 women with Oncotype DX recurrence score results of 11 to 25 (the primary study group) were randomized to receive hormonal therapy with or without chemotherapy. These randomized patients comprised 65% of all TAILORx patients and were followed for approximately 9 years, on average.

All five adult cancer research groups in the NCI's National Clinical Trials Network enrolled patients in the trial. These groups include ECOG-ACRIN, the Alliance for Clinical Trials in Oncology, NRG Oncology, SWOG, and the Canadian Cancer Trials Group. Leading breast cancer advocacy organizations, including the Breast Cancer Research Foundation, Susan G. Komen, and the National Breast Cancer Coalition, also supported the trial.

“We are proud that the Oncotype DX breast recurrence score test played a pivotal role in assigning treatment for this pioneering precision medicine trial. These TAILORx results will more precisely inform physicians and their patients with recurrence score results of 11 to 25 about who will, or will not, benefit from the addition of chemotherapy,” said Steven Shak, MD, Chief Scientific Officer, Genomic Health.  

In 2015, results from the TAILORx secondary study group with Oncotype DX breast recurrence score results less than 11 were published in The New England Journal of Medicine. More than 99% of the 1,626 women who received hormonal therapy alone without chemotherapy were free of breast cancer distant recurrence after 5 years. These results provided the highest level of evidence (level 1A) supporting the clinical utility of Oncotype DX to identify early-stage breast cancer patients who can safely avoid chemotherapy treatment.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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