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NCT06072612 · ClinicalTrials.gov registry record · Phase 3
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
A Phase 3 study of Breast Cancer and Metastatic Breast Cancer, sponsored by BriaCell Therapeutics Corporation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 404
- Enrollment target
- 20
- Study locations
NCT06072612: Recruiting Phase 3 study of Breast Cancer and Metastatic Breast Cancer, sponsored by BriaCell Therapeutics Corporation.
NCT06072612 is a Phase 3 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by BriaCell Therapeutics Corporation. The registered enrollment target is 404 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06072612, a Phase 3 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by BriaCell Therapeutics Corporation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 404 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
To evaluate the effect of the Bria-IMT regimen in combination with Check Point Inhibitor (CPI) on overall survival (OS) compared to treatment of physician's choice (TPC) chemotherapy in patients with metastatic breast cancer with no approved alternative therapies available as per the Inclusion criteria.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Retifanlimab
- BIOLOGICAL SV-BR-1-GM
- DRUG Interferon infiltration of the inoculation site
- DRUG Treatment of Physician's Choice
Study Locations (20)
California
- Los Angeles cancer Network_Anaheim - Anaheim
- Comprehensive Blood and Cancer Center - Bakersfield
- Cedars-Sinai Cancer Beverly Hills - Beverly Hills
- Los Angeles Cancer Network_Corona - Corona
- Los Angeles cancer Network_Fountain Vallley - Fountain Valley
- Los Angeles Cancer Network_Glendale - Glendale
- Hoag Hospital Center - Irvine
- Hoag Hospital Irvine - Irvine
- Los Angeles Cancer Network - Los Angeles
- Cedars-Sinai Cancer at Cedars-Sinai Medical Facility - Los Angeles
- Los Angeles Cancer Network_Century City - Los Angeles
- UCLA-Hematology/Oncology Medical Plaza - Los Angeles
- UCLA-Hematology/Oncology_LA 2 - Los Angeles
- UCLA-Hematology/Oncology_LA - Los Angeles
- Los Angeles Cancer Network_Pasadena - Pasadena
- Los Angeles cancer Network_Riverside - Riverside
- UC San Diego - San Diego
- St. John's Cancer Center - Santa Monica
Arizona
- Mayo Clinic-Comprehensive Cancer Center-Breast Clinic - Phoenix
- University of Arizona-Cancer Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 404 participants |
| Start Date | 2023-12-05 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
What NCT06072612 shows while recruiting
NCT06072612 is an interventional study that assigns participants to a tested intervention. The registered 404 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (86% lower).
The record links to 5 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06072612 names 20 study sites across 2 states, led by California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06072612 about?
NCT06072612 is a clinical study titled "Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.". 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 n...
What is the current status of trial NCT06072612?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 404 participants. The study started on 2023-12-05. Estimated completion is 2028-06.
What conditions does trial NCT06072612 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Breast Neoplasm, Breast Cancer Metastatic, End Stage Cancer.
What interventions are being tested in trial NCT06072612?
The interventions under investigation include: Cyclophosphamide (DRUG), Retifanlimab (DRUG), SV-BR-1-GM (BIOLOGICAL), Interferon infiltration of the inoculation site (DRUG), Treatment of Physician's Choice (DRUG).
Who is sponsoring clinical trial NCT06072612?
This trial is sponsored by BriaCell Therapeutics Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06072612 being conducted?
This trial has 20 study locations across Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06072612's enrollment target sits among peer trials
404 228th of 1224 higher than 997 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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