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NCT04674306 · ClinicalTrials.gov registry record · Early Phase 1
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
A Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Residual Disease, sponsored by George T. Budd.
- Active
- Registry status
- Early Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT04674306 is a Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Residual Disease that is active but no longer recruiting, run by George T. Budd. The registered enrollment target is 35 participants, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04674306, a Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Residual Disease, is active but no longer recruiting, sponsored by George T. Budd.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast cancer, and for participants who are receiving adjuvant pembrolizumab following initial triple negative breast cancer treatment.
Conditions Studied
Interventions
- BIOLOGICAL α-lactalbumin vaccine
- BIOLOGICAL Zymosan
Study Locations (1)
Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2026-05 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04674306
The ClinicalTrials.gov registry entry for NCT04674306 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is George T. Budd, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with TNBC - Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which α-lactalbumin vaccine is the first listed.
NCT04674306 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04674306 about?
NCT04674306 is a clinical study titled "Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer". The purpose of this study is to determine the safety as well as the most effective dose of the alpha-lactalbumin vaccine (aLA breast cancer vaccine) to treat patients with non-metastatic triple negative breast cancer, participants who are of cancer-free but may be at risk for triple-negative breast ...
What is the current status of trial NCT04674306?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 35 participants. The study started on 2021-10-01. Estimated completion is 2026-05.
What conditions does trial NCT04674306 study?
This clinical trial studies the following conditions: TNBC - Triple-Negative Breast Cancer, Residual Disease, Pathologic Stage IIA-IIIC Triple-Negative Breast Cancer.
What interventions are being tested in trial NCT04674306?
The interventions under investigation include: α-lactalbumin vaccine (BIOLOGICAL), Zymosan (BIOLOGICAL).
Who is sponsoring clinical trial NCT04674306?
This trial is sponsored by George T. Budd, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04674306 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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