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NCT04768426 · ClinicalTrials.gov registry record · Phase 2
Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer
A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Stanford University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04768426: Recruiting Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Stanford University.
NCT04768426 is a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Stanford University. The registered enrollment target is 40 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04768426, a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in ctDNA in the blood over time received during capecitabine treatment. Results of ctDNA analysis will be correlated to genetic characteristics of individual tumors. This may inform future clinical trials in which patients could receive a different treatment than capecitabine to reduce their risk of breast cancer relapse.
Primary Outcome
In participants with triple-negative breast cancer (TNBC) who have received standard neoadjuvant chemotherapy (NAC), levels of circulating tumor DNA (ctDNA) will be assessed at baseline and after 6 months of standard adjuvant capecitabine treatment. The outcome will be reported as the number of participants who are: * ctDNA+ (ctDNA-positive) at baseline and at 6 months. * ctDNA+ at baseline but ctDNA- (ctDNA-negative) at 6 months. * ctDNA- at baseline and at 6 months. * ctDNA- at baseline but c
Conditions Studied
Interventions
- DRUG Capecitabine
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-02-03 |
| Est. Completion | 2026-02 |
| Phase | Phase 2 |
What NCT04768426 shows while recruiting
NCT04768426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Capecitabine is the first listed.
NCT04768426 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04768426 about?
NCT04768426 is a clinical study titled "Serial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer". The purpose of the study is to evaluate the use of a circulating tumor DNA (ctDNA) assay, ie, a "liquid biopsy," as a tool to identify triple-negative breast cancer (TNBC) patients who will or will not experience benefit from treatment with capecitabine. Participants will be monitored for changes in...
What is the current status of trial NCT04768426?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2021-02-03. Estimated completion is 2026-02.
What conditions does trial NCT04768426 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer.
What interventions are being tested in trial NCT04768426?
The interventions under investigation include: Capecitabine (DRUG).
Who is sponsoring clinical trial NCT04768426?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04768426 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
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 NCT04768426's enrollment target sits among peer trials
40 876th of 1224 higher than 325 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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