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Molecular Testing and the Pathologist's Role in Clinical Trials of Breast Cancer
Hyo Sook Han1, Anthony M Magliocco2
1Department of Women's Oncology, Moffitt Cancer Center, Tampa, FL.
Abstract:
Molecular characterization of breast cancer is pivotal for identifying new molecular targets and determining the appropriate treatment choices. Advances in molecular profiling technology have given greater insight into this heterogeneous disease, over and above hormone receptor and human epidermal growth factor receptor 2 status. Agents targeting recently characterized molecular biomarkers are under clinical development; the success of these targeted agents is likely to depend on identifying the patient population most likely to benefit. Therefore, clinical trials of breast cancer often require prescreening for, or stratification by, relevant molecular markers or exploratory analyses of biomarkers that can predict or monitor the response to treatment. Consequently, the role of the pathologist has become increasingly important. The key considerations for pathologists include tissue availability, ownership of archival tissue, type of diagnostic/biomarker test required, method of sample processing, concordance between different tests and testing centers, and tumor heterogeneity. In the present review, we explore how pathology is used in current clinical trials of breast cancer and describe the various technologies available for molecular testing. Furthermore, the factors required for the successful application of pathology in clinical trials of breast cancer and the issues that can arise and how these can be circumvented are discussed.
Insights
Pathology is crucial for molecularly characterizing breast cancer in clinical trials. This involves advanced molecular testing and addressing key considerations for accurate biomarker assessment and patient stratification.
Area of Science:
- Oncology
- Pathology
- Biomarker Discovery
Background:
- Breast cancer is a heterogeneous disease requiring molecular characterization beyond traditional markers.
- Advances in molecular profiling offer deeper insights into breast cancer subtypes.
- Targeted therapies necessitate precise identification of patient populations likely to benefit.
Purpose of the Study:
- To review the role of pathology in current breast cancer clinical trials.
- To describe available molecular testing technologies for breast cancer research.
- To discuss factors and challenges for successful pathology integration in clinical trials.
Main Methods:
- Review of current literature on breast cancer clinical trials and pathology.
- Exploration of molecular profiling technologies and their application.
- Analysis of logistical and technical considerations for pathologists.
Main Results:
- Pathology plays an increasingly vital role in identifying molecular targets and stratifying patients.
- Various molecular testing technologies are available, each with specific applications.
- Successful integration requires addressing tissue handling, test concordance, and tumor heterogeneity.
Conclusions:
- Pathology is indispensable for advancing breast cancer clinical trials through molecular characterization.
- Careful consideration of logistical and technical factors is essential for reliable biomarker analysis.
- Overcoming challenges in pathology workflows will enhance the development of targeted breast cancer therapies.
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