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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 17, 2018

Status verified

Apr 2026

Primary completion

Dec 1, 2030

Completion

Dec 1, 2036

Study Design

Enrollment

739 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Active Comparator: Arm I (usual care)
  Patients will have imaging studies (modality and frequency per treating physician, however at a minimum frequency of every 12 weeks) alone or in conjunction with STMs (frequency determined by treating physician). Patients will continue with usual care disease monitoring for up to 312 weeks in the absence of disease progression.
• Experimental: Arm II (serum tumor directed disease monitoring)
  Patients undergo disease specific serum tumor marker evaluation (CEA and either CA 15-3 or CA 27.29, whichever were tested at Step 1 Registration and Step 2 Registration) every 4-8 weeks (starting from randomization) without imaging until an elevation of at least one disease specific STM. In the event of an elevated STM, the patient will have imaging within 4 weeks to evaluate for disease progression. Patients continue with STMDDM for up to 312 weeks in the absence of disease progression.

Primary Outcome Measure

Assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care [ Time Frame: Up to 312 weeks after randomization ]

Locations (709)