Actively Recruiting
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
Led by BriaCell Therapeutics Corporation · Updated on 2026-04-07
404
Participants Needed
79
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older.
- Provide signed informed consent.
- Have histological confirmation of breast cancer with locally recurrent unresectable and/or metastatic lesions.
- Have failed prior therapy appropriate to tumor type, including multiple regimens for HER2 positive, hormone receptor positive, triple negative, or tumors with actionable genomic targets.
- For patients with brain metastases, lesions must be stable without steroids and not affecting critical brain regions.
- Have an expected survival of at least 4 months.
- Have an ECOG performance status of 0, 1, or 2.
You will not qualify if you...
- Received chemotherapy, immunotherapy, or major surgery within 21 days prior to first dose.
- Had radiotherapy within 14 days prior to first dose.
- Have unresolved toxicity from prior therapy greater than Grade 1 (except alopecia and anemia not requiring transfusion).
- Experienced severe toxicity to prior checkpoint inhibitor therapy unless fully treated.
- Have hypersensitivity to study treatments or components.
- Have significant kidney, liver, blood count, or coagulation abnormalities as defined.
- Are receiving prohibited medications listed in the protocol.
- Have proteinuria greater than 2+ on urinalysis.
- Have abnormal ECG or serious heart conditions including NYHA stage 3 or 4 disease.
- Have symptomatic pleural effusion or ascites unless clinically stable after treatment.
- Are women of childbearing potential not agreeing to pregnancy prevention or with positive pregnancy test.
- Are men not sterile and not using precautions to prevent fathering a child.
- Are pregnant or nursing women.
- Have other progressing malignancies or recent history of other cancers as specified.
- Have uncontrolled HIV/AIDS or immunodeficiency.
- Are on systemic steroid or immunosuppressive therapy exceeding protocol limits.
- Have active autoimmune disease requiring recent systemic treatment.
- Have active hepatitis infections or recent systemic infections.
- Have severe psychiatric or major medical problems unless approved by investigators.
- Received live vaccine within 28 days prior to first dose.
- Are enrolled in another clinical trial unless approved by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 79 locations
1
Mayo Clinic-Comprehensive Cancer Center-Breast Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of Arizona-Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
3
Los Angeles cancer Network_Anaheim
Anaheim, California, United States, 92801
Actively Recruiting
4
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
Actively Recruiting
5
Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California, United States, 90211
Actively Recruiting
6
Los Angeles Cancer Network_Corona
Corona, California, United States, 92879
Actively Recruiting
7
Los Angeles cancer Network_Fountain Vallley
Fountain Valley, California, United States, 92708
Actively Recruiting
8
Los Angeles Cancer Network_Glendale
Glendale, California, United States, 91206
Actively Recruiting
9
Hoag Hospital Center
Irvine, California, United States, 92618
Actively Recruiting
10
Hoag Hospital Irvine
Irvine, California, United States, 92618
Actively Recruiting
11
Los Angeles Cancer Network
Los Angeles, California, United States, 90017
Actively Recruiting
12
Cedars-Sinai Cancer at Cedars-Sinai Medical Facility
Los Angeles, California, United States, 90048
Actively Recruiting
13
Los Angeles Cancer Network_Century City
Los Angeles, California, United States, 90067
Actively Recruiting
14
UCLA-Hematology/Oncology Medical Plaza
Los Angeles, California, United States, 90095
Actively Recruiting
15
UCLA-Hematology/Oncology_LA 2
Los Angeles, California, United States, 90095
Actively Recruiting
16
UCLA-Hematology/Oncology_LA
Los Angeles, California, United States, 90095
Actively Recruiting
17
Los Angeles Cancer Network_Pasadena
Pasadena, California, United States, 91105
Actively Recruiting
18
Los Angeles cancer Network_Riverside
Riverside, California, United States, 92501
Actively Recruiting
19
UC San Diego
San Diego, California, United States, 92037
Actively Recruiting
20
St. John's Cancer Center
Santa Monica, California, United States, 90404
Actively Recruiting
21
UCLA-Department of Medicine Hematology/Oncology-Parkside
Santa Monica, California, United States, 90404
Actively Recruiting
22
UCLA-Hetamtology/Oncology_S Monica
Santa Monica, California, United States, 90404
Actively Recruiting
23
Torrance Memorial Cancer Center
Torrance, California, United States, 90505
Actively Recruiting
24
Los Angeles Cancer Network_Valley Pres
Van Nuys, California, United States, 91405
Actively Recruiting
25
Cedars-Sinai Breast Health Services Building
West Hollywood, California, United States, 90048
Actively Recruiting
26
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, United States, 06511
Actively Recruiting
27
University of Miami _SCCC - Aventura
Aventura, Florida, United States, 33180
Actively Recruiting
28
University of Miami-SCCC-Lennar
Coral Gables, Florida, United States, 33146
Actively Recruiting
29
University of Miami_SCCC-Coral Springs
Coral Springs, Florida, United States, 33065
Actively Recruiting
30
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
31
University of Miami_SCCC-Hollywood
Hollywood, Florida, United States, 33021
Actively Recruiting
32
Mayo Clinic Florida-Comprehensive Cancer Center
Jacksonville, Florida, United States, 32224
Actively Recruiting
33
University Of Miami-SCCC-Miami
Miami, Florida, United States, 33136
Actively Recruiting
34
University of Miami_SCCC - Kendall
Miami, Florida, United States, 33176
Actively Recruiting
35
Advent Health - Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
36
University of Miami-SCCC-Plantation
Plantation, Florida, United States, 33324
Actively Recruiting
37
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
38
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
39
Southern Illinois University-Simmons
Springfield, Illinois, United States, 62702
Actively Recruiting
40
Carle Foundation Cancer Institute-Urbana
Urbana, Illinois, United States, 61801
Actively Recruiting
41
Northwest Cancer Center
Dyer, Indiana, United States, 46311
Actively Recruiting
42
AMR Kansas City Oncology
Kansas City, Kansas, United States, 66204
Actively Recruiting
43
Care Access-Marrero
Marrero, Louisiana, United States, 70072
Actively Recruiting
44
The Center for Cancer and Blood Disorders a division of American Oncology Partners, P.A.
Bethesda, Maryland, United States, 20817
Actively Recruiting
45
Mayo Clinic-Comprehensive Cancer Center-Breast Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
46
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
Actively Recruiting
47
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
48
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Actively Recruiting
49
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Babylon)
Babylon, New York, United States, 11702
Actively Recruiting
50
NYU Langone's Perlmutter Cancer Center
Manhattan, New York, United States, 10016
Actively Recruiting
51
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(New Hyde Park)
New Hyde Park, New York, United States, 11042
Actively Recruiting
52
Manhattan Hematology /Oncology Associates
New York, New York, United States, 10016
Actively Recruiting
53
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (NY)
New York, New York, United States, 10028
Actively Recruiting
54
New York Cancers & Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Patchogue)
Patchogue, New York, United States, 11772
Actively Recruiting
55
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Port Jefferson Station2)
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
56
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C.(Port Jefferson Station1)
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
57
New York Cancers & Blood Specialists
Port Jefferson Station, New York, United States, 11776
Actively Recruiting
58
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C. (Riverhead)
Riverhead, New York, United States, 11901
Actively Recruiting
59
New York Cancer and Blood Specialists_North Shore Hematology Oncology Assocaites P.C (Brox)
The Bronx, New York, United States, 10469
Actively Recruiting
60
Regional Medical Oncology Center_Wlson
Wilson, North Carolina, United States, 27893
Actively Recruiting
61
Gabrail Cancer & Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
62
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
63
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
64
Mary Crowley Cancer Research
Dallas, Texas, United States, 75251
Actively Recruiting
65
DHR Health Oncology Institute
Edinburg, Texas, United States, 78539
Actively Recruiting
66
Texas Oncology - Fredericksburg
Fredericksburg, Texas, United States, 78624
Actively Recruiting
67
Texas Oncology - Harlingen
Harlingen, Texas, United States, 78550
Actively Recruiting
68
Texas Oncology McAllen
McAllen, Texas, United States, 78503
Actively Recruiting
69
Texas Oncology, New Braunfels
New Braunfels, Texas, United States, 78130
Actively Recruiting
70
Texas Oncology-San Antonio Cancer Care
San Antonio, Texas, United States, 78216
Actively Recruiting
71
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States, 78217
Actively Recruiting
72
Texas Oncology - San Antonio Stone Oak
San Antonio, Texas, United States, 78258
Actively Recruiting
73
Tranquil Clinical Research
Webster, Texas, United States, 77598
Actively Recruiting
74
Texas Oncology - Weslaco
Weslaco, Texas, United States, 78596
Actively Recruiting
75
Hematology-Oncology Associates of Fredericksburg, Inc
Fredericksburg, Virginia, United States, 22408
Actively Recruiting
76
Cancer Care Northwest-1 (601 S. Sherman)
Spokane, Washington, United States, 99202
Actively Recruiting
77
Cancer Care Northwest_2 (605 E. Holland)
Spokane, Washington, United States, 99218
Actively Recruiting
78
Cancer Care Northwest
Spokane Valley, Washington, United States, 99218
Actively Recruiting
79
Sheboygan Cancer & Blood Specialists
Sheboygan, Wisconsin, United States, 53081
Actively Recruiting
Research Team
S
Sue Torchio, CPM
CONTACT
M
Marcela Salgado, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here