drugset / Trial / NCT06148038

CBD for Breast Cancer Primary Tumors

NCT06148038

Phase 1 Recruiting 84 enrolled Medical University of South Carolina
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

EvaluationDrugModalityDoseRoute
Subject Cannabidiol Other / unclassified 175 mg Oral
Subject Cannabidiol Other / unclassified 350 mg Oral

Indications