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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: Active Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Residual Disease, sponsored by George T. Budd.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD of an α-lactalbumin vaccine in participants with operable triple-negative breast cancer
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 |
What the registry record for NCT04674306 still lists
NCT04674306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for TNBC - Triple-Negative 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 NCT04674306's enrollment target sits among peer trials
35 17th of 22 higher than 5 of 22 other TNBC - Triple-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other TNBC - Triple-Negative 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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