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NCT03723928 · ClinicalTrials.gov registry record · NA
S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer
A NA study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2/Neu Negative, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- NA
- Development phase
- 739
- Enrollment target
- 20
- Study locations
NCT03723928: Recruiting NA study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2/Neu Negative, sponsored by SWOG Cancer Research Network.
NCT03723928 is a NA study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2/Neu Negative that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 739 participants, above the 154-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (380% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03723928, a NA study of Anatomic Stage IV Breast Cancer AJCC v8 and HER2/Neu Negative, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- NA
- Development phase
- 739 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The assessment of whether patients monitored with STMDDM have non-inferior overall survival compared with patients monitored with usual care will be based on multivariable Cox regression, adjusting for intervention assignment (intention-to-treat) and the stratification factor (bone only versus visceral disease). If at the time of final analysis the study shows notably fewer events than anticipated, extended follow-up will be examined for its potential to allow examination of the primary endpoint
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Usual care disease monitoring
- OTHER Serum Tumor Marker directed disease monitoring
- OTHER Anxiety Questionnaire Administration
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
California
- Kaiser Permanente-Anaheim - Anaheim
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 739 participants |
| Start Date | 2018-09-17 |
| Est. Completion | 2036-12-01 |
| Phase | NA |
What NCT03723928 shows while recruiting
NCT03723928 is an interventional study that assigns participants to a tested intervention. The registered 739 participants enrollment target is mid-sized for trials with a published cap, above the 154-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (380% higher).
The record links to 6 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT03723928 names 20 study sites across 4 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03723928 about?
NCT03723928 is a clinical study titled "S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer". 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 t...
What is the current status of trial NCT03723928?
This trial is currently recruiting. It is a NA study. The enrollment target is 739 participants. The study started on 2018-09-17. Estimated completion is 2036-12-01.
What conditions does trial NCT03723928 study?
This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, HER2/Neu Negative, Estrogen Receptor Positive, Prognostic Stage IV Breast Cancer AJCC v8, Progesterone Receptor Positive.
What interventions are being tested in trial NCT03723928?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Usual care disease monitoring (OTHER), Serum Tumor Marker directed disease monitoring (OTHER), Anxiety Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT03723928?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03723928 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Anatomic Stage IV Breast Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03723928's enrollment target sits among peer trials
739 3rd of 59 higher than 57 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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