OncoMatch/Clinical Trials/NCT06148038
CBD for Breast Cancer Primary Tumors
Is NCT06148038 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CBD Oral for breast cancer.
Treatment: CBD Oral — This is a randomized placebo controlled double blind window of opportunity trial. A maximum of 120 patients will be enrolled. Up to 60 patients with invasive breast cancer will be enrolled into cohort 1, and up to 60 patients with DCIS will be enrolled into cohort 2. Patients in each cohort will be randomized 1:1 to either CBD or placebo control using permuted block randomization with random block sizes of 2 or 4. The time window between CBD or placebo initiation and surgery will be between 5 days and 56 days.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: neoadjuvant chemotherapy
Cannot have received: 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 (measured or estimated by Cockcroft-Gault, MDRD, or CKD-EPI)
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
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