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

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8 Diagnosis HER2-positive Breast Cancer or TNBC Oncotype DX, EndoPredict, MammaPrint, BCI, Prosigna, Ki67, or IHC4 Recommendation 1.27 ➤ If a patient has HER2-positive breast cancer or TNBC, the clinician should NOT use multiparameter gene expression or protein assays (Oncotype DX, EndoPredict, MammaPrint, BCI, Prosigna, Ki67, or IHC4) to guide decisions for adjuvant endocrine and chemotherapy. (Strong recommendation; IC-Ins) Emerging Biomarkers Tumor-Infiltrating Lymphocytes (TILs) Recommendation 1.28 ➤ If a patient has node-negative or node-positive ER-positive, HER2- positive, or TNBC, the clinician should NOT use TILs test to guide decisions for (neo)adjuvant endocrine and chemotherapy. (Strong recommendation; IC-Ins) PD-L1 Testing Recommendation 1.29 ➤ If a patient has node-negative or node-positive ER-positive, HER2- positive, or TNBC, the clinician should NOT use PD-L1 testing to guide decisions for (neo)adjuvant endocrine and chemotherapy. (Strong recommendation; EB-H) Circulating Tumor Cells (CTC) Recommendation 1.30 ➤ If a patient has node-negative or node-positive ER-positive, HER2- positive, or TNBC, the clinician should NOT use CTC test to guide decisions for adjuvant endocrine and chemotherapy. (Strong recommendation; EB-I) Circulating Tumor DNA (ctDNA) Recommendation 1.31 ➤ If a patient has node-negative or node-positive ER-positive, HER2- positive, or TNBC, the clinician should NOT use ctDNA test to guide decisions for adjuvant endocrine and chemotherapy. (Strong recommendation; EB-I)

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