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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: Active Phase 1 study of Breast Cancer, sponsored by Abramson Cancer Center at Penn Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Feasibility is defined as patient tolerability of the investigational treatment and no excessive delay in surgery in our participants. The interval to breast-conserving surgery and mastectomy was based on review of our records in patients undergoing breast cancer surgery in 2016. The average time to breast conservation surgery is 24.3 days (80% between 9 and 51 days) and for mastectomy with reconstruction 41.6 days (80% between 10 and 67 days).
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 |
What the registry record for NCT04454528 still lists
NCT04454528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
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 NCT04454528's enrollment target sits among peer trials
27 1019th of 1224 higher than 198 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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