6
Diagnosis
Recommendation for Tissue Biomarkers
➤ In patients who are already receiving systemic therapy for metastatic
breast cancer, decisions on changing to a new drug or regimen or
discontinuing treatment should be based on the patient's goals for care
and clinical evaluation and judgment of disease progression or response,
given that there is no evidence at this time that changing therapy solely
on the basis of biomarker results beyond ER, PR, and HER2 improves
health outcome, quality of life, or cost effectiveness. (Moderate
recommendation; EB-L)
Recommendations for Circulating Tumor Markers
➤ In patients already receiving systemic therapy for metastatic breast
cancer, decisions on changing to a new drug or regimen or discontinuing
treatment should be based on clinical evaluation, judgment of disease
progression or response, and the patient's goals for care. There is no
evidence at this time that changing therapy based solely on circulating
biomarker results improves health outcomes, quality of life, or cost
effectiveness. (Moderate recommendation; EB-I)
Carcinoembryonic antigen (CEA), cancer antigen (CA) 15-3, and CA 27-
29 may be used as adjunctive assessments to contribute to decisions
regarding therapy for metastatic breast cancer. Data are insufficient
to recommend use of CEA, CA 15-3, and CA 27-29 alone for monitoring
response to treatment. The Panel acknowledges the lack of evidence
of clinical utility in support of use of these circulating biomarkers;
biochemical assessments of CEA, CA 15-3, and CA 27-29 were
developed before the present standards for measuring clinical utility.
The recommendation for use is based on clinical experience and Panel
informal consensus in the absence of studies designed to evaluate the
clinical utility of the markers. As such, it is also reasonable for clinicians
to not use these markers as adjunctive assessments. (Moderate
recommendation; IC-Ins)
