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Genomic Health Corporate Site
www.genomichealth.com
MyTreatmentDecision.com
www.mytreatmentdecision.com
Oncotype DX
www.oncotypeDX.com
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Trial Name: Trial Assigning IndividuaLized Options for Treatment (Rx)
Trial Purpose: The continued study of the Oncotype DX™ assay through TAILORx will help us to capture important data by evaluating women across the risk of recurrence continuum, with a particular focus on those women whose Recurrence Scores fall in the mid-range of 11 to 25, so that we can better understand the potential chemotherapy benefit for those patients.
Trial Objectives:
- To determine whether adjuvant hormonal therapy with chemotherapy is better than just adjuvant hormonal therapy in women with mid-range Recurrence Scores.
- To create a tissue and specimen bank for patients enrolled in this trial, including formalin-fixed, paraffin-embedded tumor specimens, tissue microarrays, plasma, and DNA obtained from peripheral blood. This resource will be critical for evaluating emerging clinical cancer tests.
Endpoints: The primary study endpoint is disease-free survival. Another primary endpoint is overall survival.
Patient Eligibility:* Patients with estrogen receptor-positive (ER+), lymph node-negative (N-), HER2/neu-negative (HER2-), stage I/II breast cancer
Trial Sponsor: Eastern Cooperative Oncology Group (ECOG)
Active Sites: 915**
Patients Enrolled: 1,340**
Enrollment Goal: 11,000 women
Other Important Information: Patients participating in the TAILORx clinical trial will not be responsible for the cost of the Oncotype DX test.
Additional Resources and Information:
* Additional eligibility requirements and other trial details are available at ECOG's Web site.
** As of April 30, 2007
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