NCT03723928

S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer

Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 739 (estimated)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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 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.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Estrogen Receptor Positive
• HER2/Neu Negative
• Progesterone Receptor Positive
• Prognostic Stage IV Breast Cancer AJCC v8
• Elevated CA15-3 or CEA or CA27-29

Interventions

Type	Name	Description
OTHER	Usual care disease monitoring	Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).
OTHER	Serum Tumor Marker directed disease monitoring	Serum tumor markers every 4-8 weeks without imaging
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Anxiety Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-09-17
• Primary completion: 2030-12-01
• Completion: 2036-12-01
• First posted: 2018-10-30
• Last updated: 2026-04-02

Locations

723 sites across 3 countries: United States, Guam, Puerto Rico