Last updated on August 2019

Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

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 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.

TERTIARY 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 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 6 weeks. Patients with elevated STM, undergo imaging evaluation. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.

Clinical Study Identifier: NCT03723928

Find a site near you

Start Over

Advanced Breast Care Center PLLC

Warren, MI United States
2.44miles
  Connect »

Macomb Hematology Oncology PC

Warren, MI United States
3.06miles
  Connect »

Michigan Breast Specialists-Warren

Warren, MI United States
3.06miles
  Connect »

Saint John Macomb-Oakland Hospital

Warren, MI United States
3.06miles
  Connect »

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, MI United States
5.05miles
  Connect »

Ascension Saint John Hospital

Detroit, MI United States
5.61miles
  Connect »

Lymphoma Clinic of Michigan

Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Academic Hematology Oncology Specialists

Grosse Pointe Woods, MI United States
5.61miles
  Connect »