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NCT04215146 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
A Phase 2 study of Breast Cancer Metastatic, sponsored by Oncolytics Biotech.
- Active
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 18
- Study locations
NCT04215146: Active Phase 2 study of Breast Cancer Metastatic, sponsored by Oncolytics Biotech.
NCT04215146 is a Phase 2 study of Breast Cancer Metastatic that is active but no longer recruiting, run by Oncolytics Biotech. The registered enrollment target is 48 participants, below the 90-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target (47% lower). The trial reports 18 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04215146, a Phase 2 study of Breast Cancer Metastatic, is active but no longer recruiting, sponsored by Oncolytics Biotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 18
- Study locations
Study Summary
The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy \[paclitaxel\] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.
Primary Outcome
Overall response rate at week 16 according to RECIST V1.1
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Avelumab
- BIOLOGICAL Pelareorep
Study Locations (18)
New York
- Roswell Park - Buffalo
- Icahn School of Medicine at Mount Sinai - New York
- University of Rochester Medical Center - Rochester
- Montefiore Medical Park - The Bronx
Pennsylvania
- University of Pennsylvania - Philadelphia
- Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
Virginia
- University of Virginia Cancer Center - Charlottesville
- VCU/Massey Cancer Center - Richmond
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Illinois
- Carle Cancer Center - Urbana
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
Louisiana
- Ochsner Clinic Foundation - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-06-10 |
| Est. Completion | 2025-06 |
| Phase | Phase 2 |
What the registry record for NCT04215146 still lists
NCT04215146 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 90-participant average among 17 other Breast Cancer Metastatic trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Breast Cancer Metastatic appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT04215146 lists 18 locations in 11 states (New York, Pennsylvania, Ohio).
Frequently Asked Questions
What is clinical trial NCT04215146 about?
NCT04215146 is a clinical study titled "A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study". The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy \[paclitaxel\] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which...
What is the current status of trial NCT04215146?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2020-06-10. Estimated completion is 2025-06.
What conditions does trial NCT04215146 study?
This clinical trial studies the following conditions: Breast Cancer Metastatic.
What interventions are being tested in trial NCT04215146?
The interventions under investigation include: Paclitaxel (DRUG), Avelumab (DRUG), Pelareorep (BIOLOGICAL).
Who is sponsoring clinical trial NCT04215146?
This trial is sponsored by Oncolytics Biotech, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04215146 being conducted?
This trial has 18 study locations across Florida, Illinois, Indiana, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer Metastatic
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 NCT04215146's enrollment target sits among peer trials
48 10th of 17 higher than 8 of 17 other Breast Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Metastatic 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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