RECOMMENDATIONS In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2 , the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX , EndoPredict , PAM50 , Breast Cancer Index , and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer .
No biomarker except for estrogen receptor , progesterone receptor , and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens .
PURPOSE To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer .
Randomized clinical trials with biomarkers: design issues.
Clinical biomarker tests that aid in making treatment decisions will play an important role in achieving personalized medicine for cancer patients . Definitive evaluation of the clinical utility of these biomarkers requires conducting large r and omized clinical trials ( RCTs ) . Efficient RCT design is therefore crucial for timely introduction of these medical advances into clinical practice , and a variety of design s have been proposed for this purpose . To guide design and interpretation of RCTs evaluating biomarkers , we present an in-depth comparison of advantages and disadvantages of the commonly used design s. Key aspects of the discussion include efficiency comparisons and special interim monitoring issues that arise because of the complexity of these RCTs . Important ongoing and completed trials are used as examples . We conclude that , in most setting s , r and omized biomarker-stratified design s ( ie , design s that use the biomarker to guide analysis but not treatment assignment ) should be used to obtain a rigorous assessment of biomarker clinical utility
RECOMMENDATIONS In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2 , the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX , EndoPredict , PAM50 , Breast Cancer Index , and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer .
No biomarker except for estrogen receptor , progesterone receptor , and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens .
PURPOSE To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer .