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NCT03272334 · ClinicalTrials.gov registry record · Phase 1
Her2-BATS and Pembrolizumab in Metastatic Breast Cancer
A Phase 1 study of Metastatic Breast Cancer, sponsored by University of Virginia.
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03272334: Active Phase 1 study of Metastatic Breast Cancer, sponsored by University of Virginia.
NCT03272334 is a Phase 1 study of Metastatic Breast Cancer that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 22 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03272334, a Phase 1 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy. Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.
Primary Outcome
Maximum tolerated dose will be based on number of dose limiting toxicities in each schedule/arm
Conditions Studied
Interventions
- DRUG HER2 BATs with Pembrolizumab
Study Locations (1)
Virginia
- Ashley Donihee - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-12-29 |
| Est. Completion | 2031-01 |
| Phase | Phase 1 |
What the registry record for NCT03272334 still lists
NCT03272334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which HER2 BATs with Pembrolizumab is the first listed.
NCT03272334 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT03272334 about?
NCT03272334 is a clinical study titled "Her2-BATS and Pembrolizumab in Metastatic Breast Cancer". This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an addi...
What is the current status of trial NCT03272334?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-12-29. Estimated completion is 2031-01.
What conditions does trial NCT03272334 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT03272334?
The interventions under investigation include: HER2 BATs with Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03272334?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03272334 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT03272334's enrollment target sits among peer trials
22 117th of 139 higher than 23 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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