Diagnosis
Circulating Tumor Cells
➤ The clinician should NOT use circulating tumor cells to guide decisions
on adjuvant systemic therapy. (Strong Recommendation; EB-I)
Tumor-Infiltrating Lymphocytes
➤ If a patient has ER/PgR-positive, HER2-negative (node-positive or node-
negative) breast cancer, the clinician should NOT use tumor infiltrating
lymphocytes to guide decisions on adjuvant systemic therapy.
(Strong Recommendation; IC-Ins)
➤ If a patient has HER2-positive breast cancer or TN breast cancer,
the clinician should NOT use tumor-infiltrating lymphocytes to guide
decisions on adjuvant systemic therapy. (Strong Recommendation; EB-I)
Protein Encoded By The MKI67 Gene
➤ Protein encoded by the MKI67 gene labeling index by IHC should
NOT be used to guide choice on adjuvant chemotherapy. (Moderate
Recommendation; EB-I)
Extended Endocrine Therapy
➤ If a patient has ER/PgR-positive, HER2-negative (node-negative) breast
cancer and has had 5 years of endocrine therapy without evidence
of recurrence, the clinician should NOT use multiparameter gene
expression or protein assays (Oncotype DX, EndoPredict, PAM50,
Breast Cancer Index, or IHC4) to guide decisions on extended endocrine
therapy. (Moderate Recommendation; EB-I)
Additional Biomarkers to Guide Specific Drug/Regimen Choice
Tamoxifen
➤ The clinician should NOT use CYP2D6 polymorphisms to guide adjuvant
endocrine therapy selection. (Moderate Recommendation; EB-I)
➤ The clinician should NOT use p27 expression by IHC to guide adjuvant
endocrine therapy selection. (Strong Recommendation; IC-L)
Aromatase Inhibitors
➤ The clinician should NOT use protein encoded by the MKI67 gene
labeling index by IHC to guide adjuvant endocrine therapy selection.
(Moderate Recommendation; EB-I)
Taxanes
➤ The clinician should NOT use microtubule-associated protein Tau mRNA
expression or mRNA expression by IHC to guide adjuvant chemotherapy
selection. (Moderate Recommendation; EB-I)
➤ The clinician should NOT use HER1/epidermal growth factor receptor
expression by IHC to guide adjuvant chemotherapy selection. (Moderate
Recommendation; EB-L)
