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Checkpoint Inhibitor
Bria-IMT + CPI for Advanced Breast Cancer (BRIA-ABC Trial)
Phase 3
Recruiting
Research Sponsored by BriaCell Therapeutics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be ≥ 18 years of age
Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights
BRIA-ABC Trial Summary
This trial evaluates a new treatment for advanced breast cancer with no other alternatives available.
Who is the study for?
This trial is for adults over 18 with advanced metastatic or locally recurrent breast cancer who have no other treatment options. Eligible patients must have failed prior therapy, not be suitable for local treatments, and meet specific criteria if they have brain metastases. They cannot join if they've had recent chemotherapy, radiotherapy, surgery, certain abnormal lab values, a history of other malignancies or immune conditions, unresolved toxicity from previous therapies, or are pregnant.Check my eligibility
What is being tested?
The study compares the Bria-IMT regimen combined with retifanlimab (a checkpoint inhibitor) to treatments chosen by physicians in patients with late-stage breast cancer. It's an open-label trial where participants know which treatment they're receiving and aims to see which method improves overall survival when standard therapies aren't available.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs due to retifanlimab; cyclophosphamide might cause nausea, hair loss and lower blood cell counts; interferon can lead to flu-like symptoms; plus risks associated with physician-chosen treatments.
BRIA-ABC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My breast cancer is advanced and previous treatments didn't work.
Select...
My breast cancer has spread to my brain.
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My cancer cannot be treated with surgery or radiation alone.
BRIA-ABC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival
Secondary outcome measures
CNS Event free survival (EFS)
Clinical Benefit Rate (CBR)
Overall response rate (ORR)
+2 moreBRIA-ABC Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Bria-IMT Regimen AloneExperimental Treatment3 Interventions
The Bria-IMT regimen:
Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site
Group II: Bria-IMT Regimen + CPIExperimental Treatment4 Interventions
The Bria-IMT regimen:
Day -2 or -3 Cyclophosphamide 300mg/m2 Day 0 SV-BR-1-GM given intradermally divided into 4 inoculations Day 1-3 CPI infusion plus interferon administered intra-dermally within each SV-BR-1-GM inoculation site
Group III: Treatment of Physician's ChoiceActive Control1 Intervention
TPC consists of eribulin, carboplatin, capecitabine, gemcitabine, vinorelbine or taxanes in accordance with the investigators' and institutional standard of care. The specific details of the selected regimen must include every detail of administration including frequency, sequencing (for multi-agent regimens), duration of infusion or oral administration, planned dose, dose prescribed, dose administered, dose adjustments after initial prescription or start of TPC treatment, and any other change in TPC from its initial election prior to randomization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
SV-BR-1-GM
2017
Completed Phase 2
~30
Retifanlimab
2018
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
BriaCell Therapeutics CorporationLead Sponsor
2 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Breast Cancer
36 Patients Enrolled for Breast Cancer
Giuseppe Del Priore, MD MPHStudy DirectorBriaCell Therapeutics
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA validated Bria-IMT Regimen + CPI?
"Our team at Power has assigned Bria-IMT Regimen + CPI a safety rating of 3, due to the substantial evidence from Phase 3 trials that back up both its efficacy and security."
Answered by AI
Are additional participants being accepted into this clinical research project?
"Per clinicaltrials.gov, this medical trial is not recruiting any more patients. After the initial post date of October 1st 2023 and last update on October 2nd 2023, it has been concluded that no further enrollees are required for this study; however there remains 2724 other studies who need volunteers at present time."
Answered by AI
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