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New treatment option for Breast Cancer
Official title CBD for Breast Cancer Primary Tumors
ClinicalTrials.gov ID: NCT06148038
What this study is testing
What is CBD Oral?
CBD Oral is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized placebo controlled partially blinded window of opportunity trial. A maximum of 84 patients with invasive breast cancer will be enrolled.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
You likely can't join if
- people 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...
- Self reported routine use of recreational or medicinal marijuana products, including over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis...
- Self reported concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis.
See the full eligibility criteria
- 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...
- 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)...
- 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.
- people 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.
- people 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...
- 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...
- Self reported concurrent use of over-the-counter CBD oil, Marinol®, Delta-8 THC, or cannabis.
- 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...
- Women who are pregnant or breastfeeding.
- Use of blood thinners at the time of registration (warfarin, rivaroxaban, clopidogrel, and apixaban) .
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.