Study on the Effectiveness of Pelareorep with Chemotherapy and Avelumab for Advanced Breast Cancer - BRACELET-1 Study
Sponsor: Oncolytics Biotech
ClinicalTrials ID:NCT04215146
This clinical trial is exploring whether a new combination of treatments, including the oncolytic virus pelareorep, chemotherapy drug paclitaxel, and immunotherapy drug avelumab, can better treat a type of advanced breast cancer compared to standard treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to determine if combining pelareorep with paclitaxel and avelumab is more effective in treating hormone receptor-positive, HER2-negative breast cancer that is advanced or has spread. Researchers will compare this combination to paclitaxel alone and pelareorep with paclitaxel. The safety of these treatments will also be assessed.
Description
This study involves three groups of patients with advanced hormone receptor-positive, HER2-negative breast cancer. One group will receive paclitaxel alone, another will receive pelareorep with paclitaxel, and the third will receive pelareorep, paclitaxel, and avelumab. Before starting, a small group will test the safety of the pelareorep, paclitaxel, and avelumab combination. Participants will provide blood samples and may give tumor biopsies to help researchers understand how the treatments affect the immune system and cancer cells.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Diagnosed with breast cancer that is hormone receptor-positive and HER2-negative.
- Cancer must be advanced or have spread and cannot be cured with surgery.
- Must have previously tried hormone therapy with a CDK4/6 inhibitor.
- Able to understand and sign a consent form.
- Willing to provide blood samples for research.
- Must have adequate organ function based on specific blood tests.
- Women must not be pregnant or breastfeeding and must use effective birth control during the study.
Exclusion Criteria
- No major surgery within 21 days before starting the study.
- No radiation treatment within 14 days before starting the study.
- No prior chemotherapy for advanced cancer, except in certain early-stage settings.
- No active or uncontrolled brain cancer.
- No other cancers within the past 3 years, except certain skin cancers.
- Not on chronic immunosuppressive therapy.
- No known HIV or active hepatitis infections.
- No serious infections or autoimmune diseases.
- No uncontrolled heart conditions.
- No known allergies to study medications.
- No prior treatment with certain immunotherapies.
- No participation in other clinical trials during this study.
- No recent vaccines within 14 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Carle Cancer Center | 61801 | Urbana | Illinois |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | 46202 | Indianapolis | Indiana |
| Ochsner Clinic Foundation | 70121 | New Orleans | Louisiana |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Rutgers Cancer Institute of New Jersey | 08901 | New Brunswick | New Jersey |
| Roswell Park | 14263 | Buffalo | New York |
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
| University of Rochester Medical Center | 14642 | Rochester | New York |
| Montefiore Medical Park | 10461 | The Bronx | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.