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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: 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

Study ID: NCT04215146

Study Description

Brief 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.

Detailed Description: This is an open-label randomized Phase 2, 3-cohort study to evaluate the safety and efficacy of pelareorep, paclitaxel and avelumab in Hormone Receptor+ (HR+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) with endocrine-refractory metastatic breast cancer. Patients will be randomized to one of three treatment cohorts: paclitaxel alone, pelareorep + paclitaxel, or pelareorep + paclitaxel + avelumab. A three patient safety run-in will be conducted in the cohort for pelareorep + paclitaxel + avelumab prior to beginning randomization into all three cohorts. Patients will give mandatory blood samples and optional tumor biopsies, which will be analyzed for biomarkers to determine the immunological changes within the tumor microenvironment and peripheral blood in patients treated with paclitaxel alone, in combination with pelareorep, and in combination with pelareorep and avelumab.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Carle Cancer Center, Urbana, Illinois, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

Ochsner Clinic Foundation, New Orleans, Louisiana, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

Montefiore Medical Park, Bronx, New York, United States

Roswell Park, Buffalo, New York, United States

Icahn School of Medicine at Mount Sinai, New York, New York, United States

University of Rochester Medical Center, Rochester, New York, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

University of Virginia Cancer Center, Charlottesville, Virginia, United States

VCU/Massey Cancer Center, Richmond, Virginia, United States

West Virginia University, Morgantown, West Virginia, United States

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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