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

Oncotype DX

• 1.1

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

  strongEvidence: highevidence-based
• 1.2

  In the group of patients in Recommendation 1.1 with Oncotype DX recurrence score >= 26, the clinician should offer chemoendocrine therapy.

  strongEvidence: highevidence-based
• 1.3

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

  moderateEvidence: intermediateevidence-based
• 1.4

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

  strongEvidence: highevidence-based
• 1.5

  In the group of patients in Recommendation 1.4, the clinician should offer chemoendocrine therapy for those whose Oncotype DX recurrence score is >= 26.

  strongEvidence: highevidence-based
• 1.6

  If a patient is premenopausal and has node-positive breast cancer with 1-3 positive nodes, the Oncotype DX test should not be offered to guide decisions for adjuvant systemic chemotherapy.

  moderateEvidence: highevidence-based
• 1.7

  If a patient has node-positive breast cancer with >= 4 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.

  moderateEvidence: insufficientinformal consensus

MammaPrint

• 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 the MammaPrint test to guide decisions for adjuvant endocrine and chemotherapy.

  strongEvidence: intermediateevidence-based
• 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.

  strongEvidence: highevidence-based
• 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.

  moderateEvidence: intermediateevidence-based
• 1.11

  If a patient has node-positive breast cancer with >= 4 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.

  strongEvidence: insufficientinformal consensus

EndoPredict

• 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 the EndoPredict test to guide decisions for adjuvant endocrine and chemotherapy.

  moderateEvidence: intermediateevidence-based
• 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 the EndoPredict test to guide decisions for adjuvant endocrine and chemotherapy.

  moderateEvidence: insufficientinformal consensus
• 1.14

  If a patient has breast cancer with >= 4 positive nodes, evidence on the clinical utility of routine use of the EndoPredict test to guide decisions for adjuvant endocrine and chemotherapy is insufficient.

  moderateEvidence: intermediateevidence-based

Prosigna

• 1.15

  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.

  moderateEvidence: intermediateevidence-based
• 1.16

  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.

  moderateEvidence: insufficientinformal consensus
• 1.17

  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 the Prosigna test to guide decisions for adjuvant endocrine and chemotherapy.

  moderateEvidence: intermediateevidence-based
• 1.18

  If a patient has node-positive breast cancer with >= 4 positive nodes, evidence on the clinical utility of routine use of the Prosigna test to guide decisions for adjuvant endocrine and chemotherapy is insufficient to recommend its use.

  strongEvidence: insufficientinformal consensus

Ki67

• 1.19

  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.

  moderateEvidence: intermediateevidence-based
• 1.20

  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.

  weakEvidence: lowinformal consensus
• 1.21

  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 a US Food and Drug Administration (FDA)-approved test may be offered 2 years of abemaciclib plus endocrine therapy.

  strongEvidence: intermediateevidence-based

Immunohistochemistry 4

• 1.22

  If a patient has node-negative or node-positive breast cancer with 1-3 positive nodes, the clinician may use immunohistochemistry 4 (IHC4) score to guide decisions for adjuvant endocrine and chemotherapy if the score has been validated in the performing laboratory and if multigene assays are not available.

  moderateEvidence: intermediateevidence-based

Extended Endocrine Therapy

• 1.23

  If a patient has node-negative breast cancer and has had 5 years of endocrine therapy without evidence of recurrence, there is insufficient evidence to use Oncotype DX, EndoPredict, Prosigna, Ki67, or IHC4 scores to guide decisions about extended endocrine therapy.

  moderateEvidence: intermediateevidence-based
• 1.24

  If a patient has node-negative or node-positive breast cancer with 1-3 positive nodes and has been treated with 5 years of primary endocrine therapy without evidence of recurrence, the clinician may offer the BCI test to guide decisions about extended endocrine therapy with either tamoxifen, an AI, or a sequence of tamoxifen followed by AI.

  moderateEvidence: intermediateevidence-based
• 1.25

  If a patient has node-positive breast cancer with >= 4 positive nodes and has been treated with 5 years of primary endocrine therapy without evidence of recurrence, there is insufficient evidence to use the BCI test to guide decisions about extended endocrine therapy with either tamoxifen, an AI, or a sequence of tamoxifen followed by AI.

  strongEvidence: intermediateevidence-based
• 1.26

  If a patient is postmenopausal and had invasive breast cancer and is recurrence-free after 5 years of adjuvant endocrine therapy, the clinical treatment score post-5 years (CTS5) web tool may be used to calculate the estimated risk of late recurrence (recurrence between years 5-10), which could assist in decisions about extended endocrine therapy.

  moderateEvidence: intermediateevidence-based

HER2-Positive Breast Cancer or Triple-Negative Breast Cancer

• 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.

  strongEvidence: insufficientinformal consensus

Emerging Biomarkers

• 1.28

  If a patient has node-negative or node-positive ER-positive, HER2-positive, or TNBC, the clinician should not use TILs to guide decisions for (neo)adjuvant endocrine and chemotherapy.

  strongEvidence: insufficientinformal consensus
• 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.

  strongEvidence: highevidence-based
• 1.30

  If a patient has node-negative or node-positive ER-positive, HER2-positive, or TNBC, the clinician should not use circulating tumor cells (CTC) to guide decisions for adjuvant endocrine and chemotherapy.

  strongEvidence: intermediateevidence-based
• 1.31

  If a patient has node-negative or node-positive ER-positive, HER2-positive, or TNBC, the clinician should not use ctDNA to guide decisions for adjuvant endocrine and chemotherapy.

  strongEvidence: intermediateevidence-based

Therapeutic Area

Guideline Scope

Inclusion Criteria

• women with early-stage invasive breast cancer being considered for adjuvant endocrine and chemotherapy
• ER-positive
• HER2-negative
• HER2-positive
• TNBC

Exclusion Criteria

• meeting abstracts not subsequently published in peer-reviewed journals
• editorials, commentaries, letters, news articles, case reports, and narrative reviews
• published in a non-English language

Special Populations

Evidence Levels

Recommendation Strength

Related

• Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer
• Integration of Palliative Care into Standard Oncology Care
• Patient-Clinician Communication

Comparable guidelines from other societies

• Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer
• Integration of Palliative Care into Standard Oncology Care
• Patient-Clinician Communication: ASCO Consensus Guideline