A Phase 1a Window Trial of Cannabidiol (CBD) For Breast Cancer Primary Tumors
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.
• Patients who are able to consent for surgery.
• Histologically confirmed invasive breast cancer (stages I, II, or III) with Ki67 proliferation rate greater than or equal to 10%.
• Women 18 years of age or older at time of consent.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to registration:
‣ ANC ≥ 1.5 × 109/L
⁃ Platelet count ≥ 100 × 109/L
⁃ Hemoglobin ≥ 9 g/dL
⁃ Albumin ≥ 2.5 g/dL
⁃ Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
⁃ AST, ALT, and alkaline phosphatase ≤ 3 × ULN
⁃ Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault\* glomerular filtration rate estimation:
‣ (140-age) × (weight in kg) × (0.85 if female)
‣ 72 × (serum creatinine in mg/dL)
∙ The Modification of Diet in Renal Disease (Levey et al. 2006) and the Chronic Kidney Disease Epidemiology Collaboration (Levey et al. 2009) formulas for estimation of glomerular filtration rate are also acceptable.
• Self declared ability and capacity to comply with the study and follow-up procedures.
• Subjects must be scheduled for surgery no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1.