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.
Be ≥ 18 years of age.
Have signed informed consent.
Patients with persistent disease and local recurrence must not be amenable to local treatment.
Human epidermal growth factor 2 (HER2) positive must be previously treated with at least 3 regimens containing at least two anti-HER2 and at least one chemotherapy containing regimen.
Concurrent or recent chemotherapy, immunotherapy or major surgery within 21 days prior to the first dose.
Radiotherapy within 14 days of the first dose of study treatment.
Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of any grade of alopecia and anemia not requiring transfusion support).
Any toxicity to prior CPI that was grade 3 or higher unless it has been successfully treated (e.g. hypothyroidism or hypopituitarism treated with replacement therapy), .
BriaCell Therapeutics Corporation
Lead sponsor