OncoMatch/Clinical Trials/NCT06148038
CBD for Breast Cancer Primary Tumors
Is NCT06148038 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies CBD Oral for breast cancer.
Treatment: CBD Oral — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: MKI67 expression (Ki67 ≥ 10%)
Ki67 proliferation rate greater than or equal to 10%
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: neoadjuvant chemotherapy
Subjects undergoing neoadjuvant chemotherapy
Cannot have received: neoadjuvant endocrine therapy
Subjects undergoing neoadjuvant endocrine therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min
Liver function
Bilirubin ≤ 1.5 × ULN; AST, ALT, and alkaline phosphatase ≤ 3 × ULN; Albumin ≥ 2.5 g/dL
Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to registration: ANC ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L Hemoglobin ≥ 9 g/dL Albumin ≥ 2.5 g/dL Bilirubin ≤ 1.5 × ULN AST, ALT, and alkaline phosphatase ≤ 3 × ULN Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Medical University of South Carolina · Charleston, South Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06148038 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior neoadjuvant chemotherapy, neoadjuvant endocrine therapy disqualifies patients from enrollment.
Does this trial require MKI67?
Yes, MKI67 expression is a required biomarker for enrollment.
What disease stage is eligible?
Stage I or II or III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages