General Topics -- Guidelines for the Design of Clinical Studies for the Development and Validation of Therapeutically Relevant Biomarkers and Biomarker-Based Classification Systems -- Analytical Aspects of Biomarker Immunoassays in Cancer Research -- Tissue Microarrays -- Assays for Gene Expression and Post-Translational Protein Abnormalities -- Gene Expression Profiling with DNA Microarrays -- Assays for DNA Abnormalities -- Assays for Gene Amplification -- Tissue Predictive Biomakers -- Cell Kinetics -- Urokinase-Type Plasminogen Activator and PAI-1 -- Predictive Value of c--erb-B2 for Endocrine Therapy and Chemotherapy in Breast Cancer -- erb-B2 as a Therapeutic Target -- The Epidermal Growth Factor Receptor Pathway as a Selective Molecular-Targeted Treatment in Human Breast Cancer -- p53 as a Prognostic and Predictive Indicator -- Predictive Biomarkers in Body Fluids -- Occult Metastatic Cells in Breast Cancer Patients -- Circulating HER2/neu -- Circulating Vascular Endothelial Growth Factor -- Detection of Early Tumor Dissemination in Patients With Breast Cancer -- Future Directions -- New Technologies/New Markers/New Challenges. It is now well recognized that individualized cancer treatment planning, based on tumor characteristics specific to an individual's cancer, makes it easier to select those most likely to benefit from toxic cancer therapies and to avoid treating those least likely to benefit. In Biomarkers in Breast Cancer: Molecular Diagnostics for Predicting and Monitoring Therapeutic Effect, expert laboratory and clinical researchers from around the world review how to design and evaluate studies of tumor markers, as well as examine their use in breast cancer patients. The authors cover both the major advances in sophisticated molecular methods and the state-of-the-art in conventional prognostic and predictive indicators. Among the topics discussed are the relevance of rigorous study design and guidelines to the validation of new biomarkers, gene expression profiling by tissue microarrays, adjuvant systemic therapy, and the use of estrogen, progesterone, and epidermal growth factor receptors as both prognostic and predictive indicators. Highlights include the evaluation of HER2 and EGFR family members, of p53, and of UPA/PAI-1; the detection of rare cells in blood and marrow; and the detection and analysis of soluble, circulating markers. Authoritative and cutting-edge, Biomarkers in Breast Cancer: Molecular Diagnostics for Predicting and Monitoring Therapeutic Effect offers laboratory investigators developing new tumor markers, clinical investigators testing them, and clinicians using them an up-to-date understanding of both the prognostic/predictive indicators and the novel molecular-targeted therapies suitable for individualizing breast cancer therapy.