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NCT02229084 · ClinicalTrials.gov registry record · Phase 1
Vaccination of High Risk Breast Cancer Patients
A Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 2
- Study locations
NCT02229084: Completed Phase 1 study of Breast Cancer and Breast Neoplasms, sponsored by University of Arkansas.
NCT02229084 is a Phase 1 study of Breast Cancer and Breast Neoplasms that has completed, run by University of Arkansas. The registered enrollment target is 58 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02229084, a Phase 1 study of Breast Cancer and Breast Neoplasms, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 2
- Study locations
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 estrogen-receptor (ER)-positive, HER2-negative breast cancer.
Primary Outcome
Number of participants with sufficiently high anti-P10s immunoglobulin-G response Feasibility will be evaluated in terms of 1. Generation of a sufficiently high anti-P10s immunoglobulin-G response 2. Safety and tolerability of the combination of vaccine and chemotherapy
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- DRUG Doxorubicin
- BIOLOGICAL P10s-PADRE/ MONTANIDE™ ISA 51 VG
Study Locations (2)
Arkansas
- Highlands Oncology Group - Fayetteville
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2015-01-14 |
| Est. Completion | 2023-01-03 |
| Phase | Phase 1 |
What the finished NCT02229084 record still lists
NCT02229084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT02229084 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT02229084 about?
NCT02229084 is a clinical study titled "Vaccination of High Risk 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 estrogen-receptor (ER)-positive, HER2-negative breast cancer.
What is the current status of trial NCT02229084?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2015-01-14. Estimated completion is 2023-01-03.
What conditions does trial NCT02229084 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Neoplasms.
What interventions are being tested in trial NCT02229084?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), P10s-PADRE/ MONTANIDE™ ISA 51 VG (BIOLOGICAL).
Who is sponsoring clinical trial NCT02229084?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02229084 being conducted?
This trial has 2 study locations across Arkansas. 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 NCT02229084's enrollment target sits among peer trials
58 761st of 1224 higher than 461 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.
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