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NCT02938442 · ClinicalTrials.gov registry record · Phase 1
Vaccination of Triple Negative Breast Cancer Patients
A Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02938442: Completed Phase 1 study, sponsored by University of Arkansas.
NCT02938442 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02938442, a Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.
Primary Outcome
A Safety/Tolerability Event is defined as the occurrence of one of the following: * A Serious Adverse Event, OR * A non-Serious Adverse Event of Grade = 3, 4, or 5, OR * A non-Serious Adverse Event of Grade = 2 whose Relationship to P10s-PADRE Vaccine was classified as Definite, Probable, or Possible
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Paclitaxel
- BIOLOGICAL P10s-PADRE with MONTANIDE™ ISA 51 VG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2019-01-25 |
| Est. Completion | 2023-01-09 |
| Phase | Phase 1 |
What the finished NCT02938442 record still lists
NCT02938442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02938442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02938442 about?
NCT02938442 is a clinical study titled "Vaccination of Triple Negative Breast Cancer Patients". The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant...
What is the current status of trial NCT02938442?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2019-01-25. Estimated completion is 2023-01-09.
What interventions are being tested in trial NCT02938442?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), P10s-PADRE with MONTANIDE™ ISA 51 VG (BIOLOGICAL).
Who is sponsoring clinical trial NCT02938442?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02938442's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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