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Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer

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4 Diagnosis MammaPrint (70-gene signature) Recommendation 1.8 ➤ If a patient is older than 50 and has high clinical risk breast cancer that is node-negative or node-positive with 1–3 positive nodes, the clinician may use MammaPrint test to guide decisions for adjuvant endocrine and chemotherapy. (Strong recommendation; EB-I) Recommendation 1.9 ➤ If a patient is 50 years of age or younger and has high clinical risk, node-negative or node-positive with 1–3 positive nodes breast cancer, the clinician should NOT use the MammaPrint test to guide decisions for adjuvant endocrine and chemotherapy. (Strong recommendation; EB-H). Recommendation 1.10 ➤ If a patient has low clinical risk, regardless of age, the evidence on clinical utility of routine MammaPrint test is insufficient to recommend its use. (Moderate recommendation; EB-I). Recommendation 1.11 ➤ If a patient has node-positive breast cancer with more than 3 positive nodes, the evidence on the clinical utility of routine MammaPrint test to guide decisions for adjuvant endocrine and chemotherapy is insufficient to recommend its use. (Strong recommendation; IC-Ins). Qualifying statement: The genomic assay is prognostic and may be used for shared patient-physician treatment decision making. EndoPredict (12-gene risk score) Recommendation 1.12 ➤ If a patient is postmenopausal and has breast cancer that is node- negative or node-positive with 1–3 positive nodes, the clinician may use EndoPredict test to guide decisions for adjuvant endocrine and chemotherapy. (Moderate recommendation; EB-I) Recommendation 1.13 ➤ If a patient is premenopausal and has breast cancer that is node- negative or node-positive with 1–3 positive nodes, the clinician should NOT use EndoPredict test to guide decisions for adjuvant endocrine and chemotherapy. (Moderate recommendation; IC-Ins) Recommendation 1.14 ➤ If a patient has breast cancer with more than 3 positive nodes, evidence on the clinical utility of routine use of EndoPredict test to guide decisions for adjuvant endocrine and chemotherapy is insufficient. (Moderate recommendation; EB-I)

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