Bria-IMT and Checkpoint Inhibitor for Advanced Breast Cancer

Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.

Recruiting Phase 3 Interventional Study
Breast Cancer Metastatic Breast Cancer Breast Neoplasm Breast Cancer Metastatic End Stage Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
404 (estimated)
Sponsor
BriaCell Therapeutics Corporation · Industry
Who this trial is looking for

This trial is looking for adults with advanced or locally recurrent breast cancer who have run out of treatment options. Participants will receive treatment with the Bria-IMT regimen and a checkpoint inhibitor to see how well it works compared to other standard treatments.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am 18 years or older.
  • I have signed informed consent.
  • I have been diagnosed with breast cancer that is locally recurrent or metastatic.
  • I have tried other treatments that did not work.
  • I have a life expectancy of at least 4 months.
  • I have an ECOG performance status of 0, 1, or 2.

You may not be able to join if

  • I have had chemotherapy, immunotherapy, or major surgery in the last 21 days.
  • I had radiotherapy within 14 days of starting this treatment.
  • I have not recovered from side effects of previous treatments.
  • I have a history of severe allergic reactions to any treatment in this study.
  • I have kidney problems as specified in the criteria.
  • I currently have heart disease or significant heart problems.
  • I am pregnant or nursing.
  • I have an uncontrolled medical condition like HIV.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Be ≥ 18 years of age. 2. Have signed informed consent. 3. Have histological confirmation of breast cancer with either locally recurrent unresectable and/or metastatic lesions, and have failed prior therapy: * Patients with persistent disease and local recurrence must not …
Contacts

Sue Torchio, CPM

267-797-2061

sue.torchio@PrevailinfoWorks.com

CONTACT

Marcela Salgado, MD

1-888-309-1868

MSalgado@briacell.com

CONTACT