NCT06148038

CBD for Breast Cancer Primary Tumors

A Phase 1a "Window Trial" of Cannabidiol (CBD) For Breast Cancer Primary Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	CBD Oral	CBD Oral 175mg or 350mg twice daily for 5 days-56 days
OTHER	Control	Placebo Control

Timeline

• Start date: 2026-06-15
• Primary completion: 2028-03-25
• Completion: 2029-03-25
• First posted: 2023-11-28
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study