Breast CancerPhase 1NCT06148038
CBD for Breast Cancer Primary Tumors
A Phase 1 study testing CBD Oral in people with Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CBD Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 28 Aug 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
- Known allergy to sesame. Please note the study product contains sesame oil.
- South Carolina State employees or anyone whose work requires THC drug testing.
- 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.
- 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.
- Self reported concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis.
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- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CBD or placebo.
- Underlying history of epilepsy/ recurrent seizure disorder or unexplained seizure within past 6 months.
- Patients with uncontrolled cardiovascular disease defined by myocardial infarction, stroke, or transient ischemic attack, or need for coronary stent placement within past six months.
- 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).
- Women who are pregnant or breastfeeding.
- Use of blood thinners at the time of registration (warfarin, rivaroxaban, clopidogrel, and apixaban) .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
HCC Clinical Trials Office, 843-792-9321, hcc-clinical-trials@musc.edu
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- CBD Oral, Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD OralDrug
CBD Oral 175mg or 350mg twice daily for 5 days-56 days
ControlOther
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| CBD Oral | Experimental | CBD Oral 175mg or 350mg twice daily for 5-56 days Receives: Drug: CBD Oral |
| Placebo control | Placebo comparator | Placebo control Oral twice daily for 5-56 days Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start18 Sep 2026
- Primary completion28 Aug 2030 (estimated)
- Study completion28 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148038
- Sponsor's protocol ID
- 103565
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a "Window Trial" of Cannabidiol (CBD) For Breast Cancer Primary Tumors
- ClinicalTrials.gov ID
- NCT06148038
- Acronym / sponsor ID
- 103565
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 28 Aug 2030 (estimated)
- Study completion
- 28 Aug 2031 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD Oral | Experimental | Drug: CBD OralCBD Oral 175mg or 350mg twice daily for 5-56 days |
| Placebo control | Placebo comparator | Other: ControlPlacebo control Oral twice daily for 5-56 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (12 listed)
- Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy.
- Known allergy to sesame. Please note the study product contains sesame oil.
- South Carolina State employees or anyone whose work requires THC drug testing.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD OralCBD Oral 175mg or 350mg twice daily for 5 days-56 days | Drug | CBD Oral |
| ControlPlacebo Control | Other | Placebo control |
Primary outcome
CBD and cell proliferation
Time frame: 2 months
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.
CBD and apoptosis
Time frame: 2 months
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 secondary outcomes
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
Time frame: 2 months
GAD-7 anxiety level scoring at Pre and post CBD administration
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBD Oral in people with Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HCC Clinical Trials Office (843-792-9321, hcc-clinical-trials@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBD and cell proliferation (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.