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NCT05770531 · ClinicalTrials.gov registry record · Phase 2
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy
A Phase 2 study of Metastatic Triple-Negative Breast Carcinoma and Metastatic HER2-Negative Breast Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT05770531: Recruiting Phase 2 study of Metastatic Triple-Negative Breast Carcinoma and Metastatic HER2-Negative Breast Carcinoma, sponsored by Vanderbilt-Ingram Cancer Center.
NCT05770531 is a Phase 2 study of Metastatic Triple-Negative Breast Carcinoma and Metastatic HER2-Negative Breast Carcinoma that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 160 participants, above the 46-participant average among 19 other Metastatic Triple-Negative Breast Carcinoma trials with a reported enrollment target (248% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05770531, a Phase 2 study of Metastatic Triple-Negative Breast Carcinoma and Metastatic HER2-Negative Breast Carcinoma, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.
Primary Outcome
The study survival will be estimated using the Kaplan-Meier method with 95% confidence intervals (CIs). The CI based on the Greenwoods variance will be reported. In addition, the efficacy of the study groups will be compared for PFS with log-rank tests. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age, on the survival data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence intervals wil
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Sacituzumab Govitecan
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-08-04 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
What NCT05770531 shows while recruiting
NCT05770531 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 19 other Metastatic Triple-Negative Breast Carcinoma trials with a reported enrollment target (248% higher).
The record links to 2 conditions, with Metastatic Triple-Negative Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT05770531 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT05770531 about?
NCT05770531 is a clinical study titled "Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy". This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). Th...
What is the current status of trial NCT05770531?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2023-08-04. Estimated completion is 2028-10-01.
What conditions does trial NCT05770531 study?
This clinical trial studies the following conditions: Metastatic Triple-Negative Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma.
What interventions are being tested in trial NCT05770531?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Sacituzumab Govitecan (BIOLOGICAL).
Who is sponsoring clinical trial NCT05770531?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05770531 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT05770531's enrollment target sits among peer trials
160 1st of 19 higher than 19 of 19 other Metastatic Triple-Negative Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Triple-Negative Breast Carcinoma 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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