Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer

If a patient has node-negative breast cancer, the clinician may use Oncotype DX test to guide decisions for adjuvant endocrine and chemotherapy. ( EB , H , S )

In the group of patients in Recommendation 1.1 with Oncotype DX score greater than or equal to 26, the clinician should offer chemoendocrine therapy. ( EB , H , S )

In the group of patients in Recommendation 1.1 who are 50 years of age or younger with Oncotype DX score 16 to 25, the clinician may offer chemoendocrine therapy. ( EB , I , M )

If a patient is postmenopausal and has node-positive breast cancer with 1–3 positive nodes, the clinician may use Oncotype DX test to guide decisions for adjuvant endocrine and chemotherapy. ( EB , H , S )

In the group of patients in Recommendation 1.4, the clinician should offer chemoendocrine therapy for those whose Oncotype DX score is greater than or equal to 26. ( EB , H , S )

If a patient is premenopausal and has node-positive breast cancer with 1–3 positive nodes, Oncotype DX test should NOT be offered to guide decisions for adjuvant systemic chemotherapy. ( EB , H , M )

If a patient has node-positive breast cancer with more than 3 positive nodes, the evidence on the clinical utility of routine Oncotype DX test to guide decisions for adjuvant endocrine and chemotherapy is insufficient to recommend its use. ( IC , Ins, M )

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. ( EB , I , S )

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. ( EB , H , S )

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. ( EB , I , M )

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. ( IC , Ins, S )

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. ( EB , I , M )

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. ( IC , Ins, M )

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. ( EB , I , M )

If a patient is postmenopausal and has breast cancer that is node-negative, the clinician may use the Prosigna test to guide decisions for adjuvant systemic chemotherapy. ( EB , I , M )

If a patient is premenopausal, and has node-negative or node-positive breast cancer the clinician should NOT use the Prosigna test to guide decisions for adjuvant systemic chemotherapy. ( IC , Ins, M )

If a patient is postmenopausal and has node-positive breast cancer with 1–3 positive nodes, the evidence is inconclusive to recommend the use of Prosigna test to guide decisions for adjuvant endocrine and chemotherapy. ( EB , I , M )

If a patient has node-positive breast cancer with more than 3 positive nodes, evidence on the clinical utility of routine use of Prosigna test to guide decisions for adjuvant endocrine and chemotherapy is insufficient to recommend its use. ( IC , Ins, S )

There is insufficient evidence to recommend use of Mammostrat to guide decisions about adjuvant endocrine and chemotherapy. ( EB , I , M )

If a patient has ER-positive, HER2-negative, node-negative breast cancer, the clinician may use the BCI to guide decisions for adjuvant endocrine and chemotherapy. ( EB , I , M )

If a patient has ER-positive, HER2-negative, node-positive breast cancer, the clinician should NOT use the BCI to guide decisions about adjuvant endocrine and chemotherapy. ( IC , Ins, S )

If a patient is postmenopausal and has stage I–II breast cancer, the clinician may use Ki67 expression in conjunction with other clinical and pathologic parameters to guide decisions on adjuvant endocrine and chemotherapy when multigene assays are not available. Ki67 expression levels are most informative for prognosis when the level is <5% (low proliferation) or >30% (high proliferation) because technical reliability of distinguishing values within this range is limited. ( EB , I , M )

If a patient is postmenopausal and has breast cancer, there is insufficient evidence to use baseline Ki67 expression or Ki67 level after 2 weeks of neoadjuvant aromatase inhibitor (AI) therapy to guide decisions on adjuvant endocrine and chemotherapy. ( IC , L , W )

Despite the limitations associated with Ki67 testing, a patient with node-positive breast cancer with a high risk of recurrence and a Ki67 score of ≥20% as determined by an FDA-approved test may be offered two years of abemaciclib plus endocrine therapy. ( EB , I , S )

If a patient has node-negative or node-positive breast cancer with 1–3 positive nodes, the clinician may use IHC4 test to guide decisions for adjuvant endocrine and chemotherapy if the assay has been validated in the performing laboratory and if multigene assays are not available. ( EB , I , M )

If a patient has ER-positive, HER2-negative (node-negative) breast cancer, the clinician may use the uPA and PAI-1 to guide decisions about adjuvant endocrine and chemotherapy. ( EB , H , W )

If a patient has HER2-positive breast cancer or triple-negative breast cancer (TNBC), the clinician should NOT use the uPA and PAI-1 to guide decisions about adjuvant endocrine and chemotherapy. ( IC , Ins, W )