3
Diagnosis
Newly Diagnosed ER-positive, HER2-negative Breast Cancer
Oncotype DX (21-gene recurrence score)
Recommendation 1.1
➤ If a patient has node-negative breast cancer, the clinician may use
Oncotype DX test to guide decisions for adjuvant endocrine and
chemotherapy. (Strong recommendation; EB-H)
Recommendation 1.2
➤ 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. (Strong recommendation; EB-H)
Recommendation 1.3
➤ 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. (Moderate recommendation; EB-I)
Recommendation 1.4
➤ 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. (Strong
recommendation; EB-H)
Recommendation 1.5
➤ 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. (Strong recommendation; EB-H).
Recommendation 1.6
➤ 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. (Moderate
recommendation; EB-H)
Qualifying statement: The genomic assay is prognostic and may be used for shared
patient-physician treatment decision making.
Recommendation 1.7
➤ 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. (Moderate recommendation; IC-Ins)
