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NCT03066947 · ClinicalTrials.gov registry record · Phase 1
SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
A Phase 1 study, sponsored by BriaCell Therapeutics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03066947: Completed Phase 1 study, sponsored by BriaCell Therapeutics Corporation.
NCT03066947 is a Phase 1 study that has completed, run by BriaCell Therapeutics Corporation. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03066947, a Phase 1 study, has completed, sponsored by BriaCell Therapeutics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation \~2 and \~4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.
Primary Outcome
To evaluate the number of patients with toxicity events while on SV-BR-1-GM, as defined by the Common Terminology Criteria for Adverse Events (CTCAE)
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL SV-BR-1-GM
- BIOLOGICAL Interferon-alpha-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-05-05 |
| Est. Completion | 2018-11-22 |
| Phase | Phase 1 |
What the finished NCT03066947 record still lists
NCT03066947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03066947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03066947 about?
NCT03066947 is a clinical study titled "SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer". This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days be...
What is the current status of trial NCT03066947?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-05-05. Estimated completion is 2018-11-22.
What interventions are being tested in trial NCT03066947?
The interventions under investigation include: Cyclophosphamide (DRUG), SV-BR-1-GM (BIOLOGICAL), Interferon-alpha-2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT03066947?
This trial is sponsored by BriaCell Therapeutics Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03066947's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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