404 Participants Needed

Bria-IMT + CPI for Advanced Breast Cancer

(BRIA-ABC Trial)

Recruiting at 16 trial locations
MS
MT
Overseen ByMaggie Tomasini, CPM
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This is a multicenter randomized, open label study to evaluate overall survival with the Bria-IMT regimen in combination with Checkpoint Inhibitor [Retifanlimab], versus Treatment of Patients'/Physicians' Choice (TPC) in advanced metastatic or locally recurrent breast cancer (aMBC) patients with no approved alternative therapies available.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it does mention that you cannot be on certain prohibited medications. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the treatment Bria-IMT + CPI for Advanced Breast Cancer?

The research highlights that modern immunotherapy strategies, like checkpoint blockade, have shown promising results in breast cancer treatment, particularly when combined with other therapies. For example, combining atezolizumab with nab-paclitaxel improved progression-free survival in metastatic triple negative breast cancer, suggesting that similar combination strategies could enhance the effectiveness of treatments like Bria-IMT + CPI.12345

What makes the Bria-IMT + CPI treatment for advanced breast cancer unique?

The Bria-IMT + CPI treatment is unique because it combines Retifanlimab, a checkpoint inhibitor that helps the immune system attack cancer cells, with SV-BR-1-GM, a vaccine designed to stimulate an immune response specifically against breast cancer cells. This combination aims to enhance the body's immune response to target and control advanced breast cancer more effectively than traditional treatments.13678

Research Team

GD

Giuseppe Del Priore, MD MPH

Principal Investigator

BriaCell Therapeutics

Eligibility Criteria

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.

Inclusion Criteria

Have signed informed consent
I am 18 years old or older.
My breast cancer is advanced and previous treatments didn't work.
See 3 more

Exclusion Criteria

You are pregnant, trying to have a baby, or breastfeeding.
My side effects from previous treatments have mostly gone away.
My kidney function is within the required range.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Bria-IMT regimen with or without CPI, or Treatment of Physician's Choice (TPC) in cycles every 3 weeks

Up to 60 months
Every 3 weeks

Imaging Assessment

Imaging assessments occur every 6 weeks for the first two cycles, then every 8 weeks thereafter

Up to 60 months
Every 6 weeks x2, then every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 60 months

Treatment Details

Interventions

  • Cyclophosphamide
  • Interferon infiltration of the inoculation site
  • Retifanlimab
  • SV-BR-1-GM
Trial OverviewThe 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.
Participant Groups
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.

Retifanlimab is already approved in United States for the following indications:

🇺🇸
Approved in United States as Zynyz for:
  • Merkel cell carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

BriaCell Therapeutics Corporation

Lead Sponsor

Trials
4
Recruited
480+

Findings from Research

In a phase I trial involving 23 women with metastatic breast cancer, the infusion of anti-CD3 × anti-HER2 bispecific antibody-armed T cells (aATC) was found to be safe, with no dose-limiting toxicities and a maximum tolerated dose not defined, indicating a promising safety profile for this immunotherapy approach.
The treatment led to significant anti-tumor responses, with 59.1% of evaluable patients achieving stable disease and a median overall survival of 36.2 months, suggesting that aATC infusions effectively activated the immune system against breast cancer.
Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial.Lum, LG., Thakur, A., Al-Kadhimi, Z., et al.[2021]
Recent advancements in therapies for advanced breast carcinoma include CDK4/6 inhibitors, oral selective estrogen receptor degraders, antibody drug conjugates, and PARP inhibitors, which have shown promising results in improving patient outcomes.
Key studies, such as the Destiny-Breast03 and RIGHT Choice studies, indicate that these new treatments may significantly alter the therapeutic landscape, offering new hope for patients facing advanced breast cancer.
Update Breast Cancer 2023 Part 2 - Advanced-Stage Breast Cancer.Lux, MP., Hartkopf, AD., Fehm, TN., et al.[2023]
Immunotherapy, particularly using monoclonal antibodies that target immune checkpoint receptors, has shown significant promise in improving outcomes for breast cancer patients, especially those with triple-negative breast cancer.
The combination of atezolizumab and nab-paclitaxel as a first-line treatment for metastatic triple-negative breast cancer resulted in notable improvements in progression-free survival compared to chemotherapy alone, suggesting that combining therapies may enhance effectiveness.
Checkpoint Blockade Strategies in the Treatment of Breast Cancer: Where We Are and Where We Are Heading.Force, J., Leal, JHS., McArthur, HL.[2022]

References

Targeted T-cell Therapy in Stage IV Breast Cancer: A Phase I Clinical Trial. [2021]
Update Breast Cancer 2023 Part 2 - Advanced-Stage Breast Cancer. [2023]
Checkpoint Blockade Strategies in the Treatment of Breast Cancer: Where We Are and Where We Are Heading. [2022]
Current frontline endocrine treatment options for women with hormone receptor-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative advanced-stage breast cancer. [2019]
Pertuzumab, trastuzumab and eribulin mesylate therapy for previously treated advanced HER2-positive breast cancer: a feasibility study with analysis of biomarkers. [2019]
What's in a Name? That Which We Call Immune Cells by Any Other Name Would All Smell as Sweet. [2022]
Improving the Odds in Advanced Breast Cancer With Combination Immunotherapy: Stepwise Addition of Vaccine, Immune Checkpoint Inhibitor, Chemotherapy, and HDAC Inhibitor in Advanced Stage Breast Cancer. [2023]
ICON: a randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with metastatic hormone receptor positive breast cancer. [2022]