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NCT04095689 · ClinicalTrials.gov registry record · Phase 2
Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer
A Phase 2 study, sponsored by The Methodist Hospital Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT04095689: Clinical Trial Phase 2 study, sponsored by The Methodist Hospital Research Institute.
NCT04095689 is a Phase 2 study that was terminated before completion, run by The Methodist Hospital Research Institute. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04095689, a Phase 2 study, was terminated before completion, sponsored by The Methodist Hospital Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).
Primary Outcome
To determine the pCR rate of docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy in patients with TNBC per RECIST v1.1 assessed by CT Scan or MRI. CR: Disappearance of all target lesions. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, using the baseline sum longest diameter as a reference. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, using the smallest sum longest diameter as a reference. PD: At leas
Interventions
- DRUG Pembrolizumab
- DRUG Docetaxel
- DRUG IL-12 gene therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-05-12 |
| Est. Completion | 2024-06-03 |
| Phase | Phase 2 |
Why NCT04095689 stopped before completion
NCT04095689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04095689 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04095689 about?
NCT04095689 is a clinical study titled "Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer". The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).
What is the current status of trial NCT04095689?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2021-05-12. Estimated completion is 2024-06-03.
What interventions are being tested in trial NCT04095689?
The interventions under investigation include: Pembrolizumab (DRUG), Docetaxel (DRUG), IL-12 gene therapy (DRUG).
Who is sponsoring clinical trial NCT04095689?
This trial is sponsored by The Methodist Hospital Research Institute, which has 126 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04095689's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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