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Biomarkers for Systemic Therapy in Metastatic Breast Cancer

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5 Recommendation 8.1 ➤ Clinicians may test for NTRK fusions in patients with metastatic cancer who are candidates for a treatment regimen that includes a tyrosine receptor kinase (TRK) inhibitor to determine eligibility for larotrectinib or entrectinib. (Moderate recommendation; IC-L) Recommendation 9.1 ➤ There are insufficient data to recommend routine testing of tumors for TROP2 expression to guide therapy with an anti-TROP2 antibody-drug conjugate for hormone receptor-negative, HER2-negative metastatic breast cancer. (Moderate recommendation; IC-L) Recommendation 10.1 ➤ There are insufficient data to recommend routine use of ctDNA to monitor response to therapy among patients with metastatic breast cancer. (Moderate recommendation; IC-L) Recommendation 11.1 ➤ There are insufficient data to recommend routine use of CTCs to monitor response to therapy among patients with metastatic breast cancer. (Moderate recommendation; IC-I) Recommendations Unchanged From 2015 Guideline ➤ At initial presentation of metastasis from breast cancer, it is standard of care to biopsy an accessible lesion to confirm metastatic breast cancer. When evaluating the metastatic site(s), it is important to note that the results of estrogren receptor (ER), progesterone receptor (PR), and/or HER2 status may have changed from the primary tumor, and these results may inform treatment decisions. Therefore, this Panel recommends retesting for ER, PR, and HER2 on ≥ one metastasis with careful attention to assay performance, particularly for bone metastases. However, for patients with documented changes in these biomarkers, data are lacking to determine whether outcomes from systemic therapy are altered when guided by biomarker test results from the metastases. The Panel informal consensus for the management of care when there is discordance of ER, PR, or HER2 results between primary and metastatic tissues is to use the ER, PR, or HER2 status from the metastasis to direct therapy, if supported by the clinical scenario and the patient's goals for care. (Moderate recommendation; EB-Ins for biomarker change from primary to metastasis, but no evidence to demonstrate that systemic therapy choices affect health outcomes when biomarker change occurs.)

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