MercyOne Waterloo Medical Center(2.7 mi away)Contact
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This randomized research trial studies how well serum tumor marker directed disease
monitoring works in monitoring patients with hormone receptor positive Her2 negative breast
cancer that has spread to other places in the body. Using markers to prompt when scans should
be ordered may be as good as the usual approach to monitoring disease.
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.
I. To compare cumulative direct healthcare costs 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.
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 into 1 of 2 arms.
ARM 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.
ARM II: Patients undergo disease specific serum tumor marker (STM) evaluation every 4-8
weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM
for up to 312 weeks in the absence of disease progression.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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