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

NCT03723928 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 739

Last updated 2026-04-02

No results posted yet for this study

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.

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

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Melissa Accordino · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2030-12-01
Completion
2036-12-01

Countries

  • United States
  • Guam
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03723928 on ClinicalTrials.gov