drugset / Trial / NCT06148038
CBD for Breast Cancer Primary Tumors
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a randomized placebo controlled partially blinded window of opportunity trial. A maximum of 84 patients with invasive breast cancer will be enrolled. Patients will be randomized 2:2:1:1 to either CBD low dose, CBD high dose, matching low dose placebo, or matching high dose placebo using permuted block randomization with random block sizes of 6 or 12. The time window between CBD or placebo initiation and surgery will be between 5 and 56 days.
Timeline
- Start
- 2026-09-15
- Primary completion
- 2028-03-25
- Completion
- 2029-03-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 175 mg | Oral |
| Subject | Cannabidiol | Other / unclassified | 350 mg | Oral |