Comparing Overall Survival using Markers to Direct Cancer Monitoring versus Usual Monitoring in Patients with Metastatic Hormone Receptor Positive HER-2 Negative Breast Cancer

Summary

Objectives

PRIMARY OBJECTIVE:
I. 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.

SECONDARY OBJECTIVES:
I. To compare cumulative direct healthcare costs (in the United States) through 48 weeks among patients monitored with STMDDM versus those monitored with usual care in this patient population.
II. 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.

OTHER OBJECTIVES:
I. To assess modality and frequency of disease monitoring testing in the usual care cohort.
II. To assess the association of PROs and patient preferences for disease monitoring testing.
III. To evaluate predictors of physician preferences for disease monitoring testing.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo imaging studies during screening and at a minimum frequency of every 12 weeks on study and continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression. Patients also undergo blood sample collection during screening and as clinically indicated on study.

ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation via blood sample collection during screening and every 4-8 weeks on study. Patients with elevated STM undergo imaging evaluation on study. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.