RecruitingBreast Cancer
CBD for Breast Cancer Primary Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Medical University of South Carolina
You may qualify if…
- ✓ 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. Menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes.
- ✓ 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- ✓ 6. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to registration:
- ✓ 1. ANC ≥ 1.5 × 109/L
- ✓ 2. Platelet count ≥ 100 × 109/L
You may not qualify if…
- ✕ 1. Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
- ✕ 2. Known allergy to sesame. Please note the study product contains sesame oil.
- ✕ 3. South Carolina State employees or anyone whose work requires THC drug testing.
- ✕ 4. Patients taking drugs metabolized by cytochrome p450 including warfarin, amiodarone, levothyroxine, clobazam, lamotrigine, valproate, prednisolone, hydrocortisone, clarithromycin, itraconazole, erythromycin, fluconazole, clopidogrel, rifampin, sulfamethoxazole, any opioids, and antiepileptic medications including carbamazapine, phenytoin, and valproic acid.
- ✕ 5. Self reported routine use of recreational or medicinal marijuana products, including over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis (defined as \> 4 times over last 30 days) or illicit drug use including opioids, cocaine, amphetamines, PCP, LSD.
- ✕ 6. Self reported concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis.
- ✕ 7. History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBD or placebo.
- ✕ 8. Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months.
Where it's recruiting
South Carolina
Charleston
Source: ClinicalTrials.gov · NCT06148038 · last updated 2026-06-22