A Phase 1a "Window Trial" of Cannabidiol (CBD) For Breast Cancer Primary Tumors
Medical University of South Carolina
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients who are able to consent for surgery. 2. Histologically confirmed invasive breast cancer (stages I, II, or III) with Ki67 proliferation rate greater than or equal to 10%. 3. Women 18 years of age or older at time of consent. 4. Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. M…
Interventions
- DrugCBD Oral
CBD Oral 175mg or 350mg twice daily for 5 days-56 days
- OtherControl
Placebo Control
Location
- Medical University of South CarolinaCharleston, South Carolina