CBD for Breast Cancer Primary Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Control; Drug: CBD Oral

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: HCC Clinical Trials Office; Phone Number: 843-792-9321; Email: hcc-clinical-trials@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: HCC Clinical Trials Office; Phone Number: 843-792-9321; Email: hcc-clinical-trials@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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. 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
   3. Hemoglobin ≥ 9 g/dL
   4. Albumin ≥ 2.5 g/dL
   5. Bilirubin ≤ 1.5 × the upper limit of normal (ULN)
   6. AST, ALT, and alkaline phosphatase ≤ 3 × ULN

   7. 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.
7. Self declared ability and capacity to comply with the study and follow-up procedures.
8. 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.

Exclusion Criteria:

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.
9. Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke, or transient ischemic attack, or need for coronary stent placement within past six months.
10. Patients with a medical history of psychiatric illness or psychiatric symptoms that would prevent them from completing study procedures or would disqualify them from surgical intervention (e.g., untreated schizophrenia, bipolar disorder, or suicide ideation/attempt resulting in psychiatric hospitalization within the last 30 days).
11. Women who are pregnant or breastfeeding.
12. Use of blood thinners at the time of registration (warfarin, rivaroxaban, clopidogrel, and apixaban) .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBD Oral; CBD Oral 175mg or 350mg twice daily for 5-56 days	Drug: CBD Oral; CBD Oral 175mg or 350mg twice daily for 5 days-56 days
Placebo Comparator: Placebo control; Placebo control Oral twice daily for 5-56 days	Other: Control; Placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CBD and cell proliferation	To determine whether oral administration of cannabidiol (CBD) causes biological changes related to cell proliferation (using Ki67 expression as a marker) in primary tumors of breast cancer patients.	2 months
CBD and apoptosis	To determine whether oral administration of cannabidiol (CBD) causes biological changes related to apoptosis (using Ki67 expression as a marker) in primary tumors of breast cancer patients.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0	To determine adverse event relationship to oral CBD extract in patients with breast cancer.	2 months
GAD-7 anxiety level scoring at Pre and post CBD administration	To determine whether CBD administered in the period waiting for surgery reduces self-reported anxiety from baseline to time of surgery as measured by the GAD-7 patient reported outcomes scale.	2 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2029

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: November 18, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 103565

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No