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#1092 The American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer suggests the use of the invasion markers urokinase-type plasminogen activator (uPA) and its inhibitor PAI-1 for risk assessment (Harris et al. JCO 25:5287). In 2003, we launched the NNBC 3-Europe trial for node negative breast cancer patients with the following questions:
 1) Comparison of risk-assessment: invasion markers uPA/PAI-1 vs. clinico-pathological factors.
 2) Comparison of adjuvant FEC-Docetaxel (anthracycline-taxane sequence) vs. standard FEC in high-risk patients?
 3) Use of fresh tissue sampling was necessary within this trial. Quality assurance for the testing procedure was prospectively performed.
 Study Design: Risk assessment is performed either by clinico-pathological factors or by uPA/PAI-1. High-risk patients receive adjuvant chemotherapy according to randomisation. Adjuvant endocrine therapy is given according to guidelines. All laboratories take part on the central quality assurance program. In addition, we also analyzed feasibility of uPA/PAI-1 determination from core needle biopsies.
 Results:To date, from 131 participating centres, 3060 patients have been registered for the trial. Biological risk assessment was performed in 2000 patients. Using both tumor grade and uPA/PAI-1 results, the low-risk group comprises 38% of the patients, whereas 62% were considered high-risk and randomized for the adjuvant chemotherapy question. All centres show a well established collaboration with the pathologists who were responsible for histological confirmation of the frozen tumor samples and for the weekly shipment to the central labs. Mean coefficients of variation (CV) for between-lab and within-lab are 12% for uPA and PAI-1. Using core needle biopsies (n=36) in comparison to larger tumor pieces, we found a rather good correlation (r=0.89; p<0.003) with predictive values of 0.93 (ppv), 0.86 (npv).
 Discussion: Biological testing of fresh frozen tumor material is feasible in day-to-day clinical practice. For uPA/PAI-1 determination core needle biopsy material, use of at least three core needle specimens can be accepted. Multicenter quality assurance of uPA/PAI-1 determination was satisfactory. Using uPA/PAI-1 and tumor grade for low-risk identification, adjuvant chemotherapy may be avoided in about 38% of node-negative breast cancer patients.
 The NNBC 3-Europe trial is planned to recruit 5.700 patients and it is performed in cooperation with the EORTC Patho-Biology Group, the German AGO Breast Group, and the GBG.
 Unrestricted grants by Sanofi-Aventis, Pfizer, American Diagnostica, and NBL Funding of University Halle. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 1092.

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