Patients continue with STMDDM for up to 312 weeks in the absence of disease progression. Patients with elevated STM, undergo imaging evaluation. OUTLINE: Patients are randomized into 1 of 2 arms.ĪRM I: Patients undergo imaging studies at a minimum frequency of every 12 weeks and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.ĪRM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8 weeks. To evaluate predictors of physician preferences for disease monitoring testing. To assess the association of PROs and patient preferences for disease monitoring testing. To assess modality and frequency of disease monitoring testing in the usual care cohort. To assess whether the patient-reported outcomes (PROs) of anxiety and quality of life (QOL) are different among patients who are monitored with STMDDM compared with patients who are monitored with usual care in this patient population. To compare cumulative direct healthcare costs through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population. To assess whether patients with HER-2 negative, hormone receptor positive, metastatic breast cancer who are monitored with serum tumor marker directed disease monitoring (STMDDM) have non-inferior overall survival compared to patients monitored with usual care.
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