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 (NCT04215146)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- University of Miami Sylvester Comprehensive Cancer Center — Miami, Florida
- Carle Cancer Center — Urbana, Illinois
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana
- Ochsner Clinic Foundation — New Orleans, Louisiana
- Washington University School of Medicine — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Roswell Park — Buffalo, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Montefiore Medical Park — The Bronx, New York
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- University of Pennsylvania — Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania
- Fox Chase Cancer Center — Philadelphia, Pennsylvania
- University of Virginia Cancer Center — Charlottesville, Virginia
- VCU/Massey Cancer Center — Richmond, Virginia
- West Virginia University — Morgantown, West Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.