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CBD for Breast Cancer Primary Tumors

NCT06148038 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-09

No results posted yet for this study

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

Interventions

DRUG

CBD Oral

CBD Oral 175mg or 350mg twice daily for 5 days-56 days

OTHER

Control

Placebo Control

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2028-03-25
Completion
2029-03-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06148038 on ClinicalTrials.gov