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NCT04454528 · ClinicalTrials.gov registry record · Phase 1
BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy
A Phase 1 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT04454528 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 27 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04454528, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Abramson Cancer Center at Penn Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to assess immune response on pre and post treatment blood and tissue samples by tracking change in Ki67 + CD8 T cells in peripheral blood and in extent of tumor infiltrating lymphocytes. A clinically significant partial response is defined as \>30% tumor shrinkage post-clinical trial intervention.
Conditions Studied
Interventions
- DRUG Pembrolizumab infusion
- RADIATION Hypofractionated radiotherapy
- PROCEDURE Blood and tissue sampling
Study Locations (1)
Pennsylvania
- Perelman Center for Advanced Medicine - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-12-07 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04454528
The ClinicalTrials.gov registry entry for NCT04454528 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Abramson Cancer Center at Penn Medicine, which has 402 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab infusion is the first listed.
NCT04454528 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04454528 about?
NCT04454528 is a clinical study titled "BreastVAX: Radiation Boost to Enhance Immune Checkpoint Blockade Therapy". The primary objective is to determine the feasibility of combining pembrolizumab with a single fraction radiation boost in patients with early/ operable breast cancer. The secondary objectives are to assess clinical response on pre- and post-treatment clinical, imaging, and histology exams, and to a...
What is the current status of trial NCT04454528?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2020-12-07. Estimated completion is 2027-08.
What conditions does trial NCT04454528 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04454528?
The interventions under investigation include: Pembrolizumab infusion (DRUG), Hypofractionated radiotherapy (RADIATION), Blood and tissue sampling (PROCEDURE).
Who is sponsoring clinical trial NCT04454528?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04454528 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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