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

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT03723928

Title field or adapter rule

{'original_value': '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', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:30.701713+00:00

Published At

2026-10-23T00:00:00+00:00

Record Updated At

2026-10-23

Source Retrieved At

2026-10-31T22:18:24.976182+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.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"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2026-10-23", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT03723928"

protocolSection.identificationModule.officialTitle

"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"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["NA"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

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

Interventions recorded in this study

• {'armGroupLabels': ['Arm I (usual care)'], 'description': 'Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).', 'name': 'Usual care disease monitoring', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm II (serum tumor directed disease monitoring)'], 'description': 'Serum tumor markers every 4-8 weeks without imaging', 'name': 'Serum Tumor Marker directed disease monitoring', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm I (usual care)', 'Arm II (serum tumor directed disease monitoring)'], 'description': 'Ancillary studies', 'name': 'Quality-of-Life Assessment', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['Arm I (usual care)', 'Arm II (serum tumor directed disease monitoring)'], 'description': 'Ancillary studies', 'name': 'Anxiety Questionnaire Administration', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

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