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Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT06538389

High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer

A Phase 2 study testing Biospecimen Collection, BRC-001 and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Biospecimen Collection, BRC-001 and Questionnaire Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteUnited States
Study dates
26 Aug 2024to 24 Jan 2027
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented informed consent of the participant
  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Postmenopausal by last menses > 12 months or medically induced menopause in premenopausal women for AI therapy use
  • At least 5 years since other malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer from which the patient is currently in complete remission
  • Ability to read and understand English, Spanish, or translations by interpreters for questionnaires
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  • Histologically confirmed primary invasive adenocarcinoma of the breast or ductal carcinoma in situ of the breast
  • Stage 0, I, II, or IIIA disease
  • No metastatic disease
  • Must have undergone definitive breast cancer surgery and recovered
  • Must have completed adjuvant chemotherapy as applicable, including systemic chemotherapy, anti-HER2 therapy, and/or radiation therapy
  • Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+)
  • Currently taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole [Arimidex (registered trademark)], letrozole [Femara (registered trademark)], or exemestane [Aromasin (registered trademark)]) for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration
  • Must have a worst pain/stiffness of ≥ 4 on the Brief Pain Inventory (BPI) (item #2) that has started or increased with AI therapy

Who cannot join

  • < 3 months since prior cannabinoid containing cannabis or hemp products including CBD, tetrahydrocannabinol (THC), Marinol, and Epidiolex and must agree to refrain from use from sources outside of this study
  • < 28 days since prior investigational agents
  • Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days
  • Narcotic use within 14 days of registration
  • Patients may have received corticosteroid treatment; however, the following criteria apply:
  • Patients must not have received oral or intramuscular corticosteroids within 28 days prior to registration
Show all 27Show fewer
  • Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration
  • Patients must not have received topical analgesics (e.g., capsaicin preparations) to the study joint or any other analgesics (e.g., opiates, tramadol; with exception of nonsteroidal anti-inflammatory drugs [NSAIDs] and acetaminophen) within 14 days prior to registration
  • History of bone fracture or surgery of the afflicted hands, knees, and/or other joints within 6 months prior to registration
  • Any uncontrolled illness including ongoing or active infection
  • Known allergies or contraindications to cannabis
  • Significantly impaired hepatic function (alanine aminotransferase [ALT] > 5 x upper limit of normal [ULN] or total bilirubin [TBL] > 2 x ULN) OR the ALT or aspartate aminotransferase (AST) > 3 x ULN and TBL > 2 x ULN (or international normalized ratio [INR] > 1.5
  • Grade 3+ renal impairment
  • Clinically significant lab abnormalities in ALT, AST, total bilirubin, hemoglobin, hematocrit, or creatinine or any other laboratory tests that in the opinion of the investigator would prevent the patient from safely participating in the study
  • Having current thoughts of suicide or self-harm or history of suicidal ideation or attempted suicide
  • Meeting Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current major psychiatric illness, such as bipolar disorder, major depression, or psychosis (including schizophrenia and affective psychosis)
  • History of seizure disorder
  • Concomitant administration with drugs that may interact adversely with CBD including warfarin, theophylline, amiodarone, anti-epileptic (e.g., clobazam, stiripentol, valproate, topiramate), anticonvulsant (e.g., diazepam, lamotrigine, phenytoin, ethosuximide, oxcarbazepine, pregabalin, tigabine, gabapentin); 3) barbiturate (e.g., phenobarbital, hexobarbital), benzodiazepine (e.g, chlordiazepoxide, clonazepam), opioid/narcotic (e.g, codeine, morphine)
  • Concomitant administration of cyclin-dependent kinase 4/6 inhibitors, such as abemaciclib, with AI therapy
  • Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safely participating in the study
  • Other active malignancy
  • Any other condition or medication use that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Participants unwilling to abstain from donation of blood during the study
  • Participants who plan to travel outside of the United States during the study period
  • Women with childbearing potential are not eligible to participate. The study is for postmenopausal women taking aromatase inhibitors for adjuvant endocrine therapy
  • Participants with cognitive impairment are excluded due to dose titration instructions and completion of questionnaires
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: High Cannabidiol (CBD) Standardized Extract for Aromatase Inhibitor-Induced Arthralgia - A Randomized Controlled Double Blind Clinical Trial

This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs). AIs lower blood levels of estrogen in postmenopausal women to reduce breast cancer recurrence. Women on AI therapy may experience joint stiffness, pain and arthritis symptoms as a side effect of the medication. Some women stop AI therapy due to these side effects and do not receive the maximum benefit from the medication. CBD is derived from the same plant family as marijuana but is not associated with a "high" or mind-altering effect and is not habit-forming. Research in animals and humans indicates that CBD might decrease inflammation in joint tissues and may help reduce chronic pain in ailments such as arthritis. BRC-001 may reduce joint pain in women with breast cancer taking AIs.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess the preliminary efficacy of BRC-001 versus placebo by change in Brief Pain Inventory-Short Form (BPI-SF) worst pain severity scores from 0 to 3 months.

SECONDARY OBJECTIVES:

  1. To evaluate indicators of preliminary efficacy of BRC-001 on joint symptoms of pain and stiffness assessed by BPI-SF total pain severity and total pain interference scores and Visual Analog Scale-Pain.

II. To evaluate tolerability by adverse events, anxiety by Patient Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form (SF) 6a, sleep by PROMIS Sleep Disturbance SF 4a, quality of life by Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES).

III. To evaluate safety by clinical laboratory tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], total bilirubin).

IV. To evaluate changes in physical function by dynamometer measurements of grip strength.

EXPLORATORY OBJECTIVES:

  1. To evaluate blood-based biomarkers related to aromatase inhibitor-induced arthralgia (AIIA) and BRC-001 versus (vs) placebo.

II. Pharmacokinetics of BRC-001.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive BRC-001 orally (PO) twice daily (BID) for up to 3 months. Patients also undergo blood sample collection on study.

ARM II: Patients receive placebo PO BID for up to 3 months. Patients also undergo blood sample collection on study.

After completion of study treatment, patients are followed up at 30 days.

Being tested
Biospecimen Collection, BRC-001, Placebo Administration, Questionnaire Administration
Medical subject headings
Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • BRC-001Drug

    Also called Cannabidiol, CBD, CBD Oil

    Given PO

  • Placebo AdministrationDrug

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06538389
Study groupRoleWhat they receive
Arm I (BRC-001)ExperimentalParticipants will be started on a flexible dosing regimen of BC-001, initiating therapy at 200 mg daily and up-titrated based on tolerability over 2 weeks to a maximum of 800 mg daily. Dose increases are recommended to take place in the evening, beginning the evening dose of Day 2. During the Titration Period, study participants may increase the study agent dose every 2 days by 1 mL total (.5 mL per dose) as tolerated. The increment of increase for BRC-001 is 100 mg per 1.0 mL. Patients receive BRC-001 PO BID for up to 3 months. Patients also undergo blood sample collection on study.
Receives: Procedure: Biospecimen Collection; Drug: BRC-001; Other: Questionnaire Administration
Arm II (Placebo)Placebo comparatorPlacebo will be self-administered with twice daily doses according to the Titration Period schedule for the first two weeks to the highest tolerable dose up to 4 mL twice daily. Patients receive placebo PO BID for up to 3 months. Patients also undergo blood sample collection on study.
Receives: Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Brief Pain Inventory-Short Form (BPI-SF) score

    The Brief Pain Inventory (BPI) can assess the severity of chronic and acute pain for both behavioral and pharmacological pain interventions. Higher scores from 0 (no pain) to 10 (pain as bad as you can imagine) indicate increased levels of pain. Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: From 0 to 3 months

Secondary outcomes (7)

  1. Changes in Visual Analog Scale (VAS) for Pain

    The Visual Analogue Scale (VAS) measures pain intensity with two end points (0=no pain and 10=worst pain). Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: From 0 to 3 months

  2. Changes in Functional Assessment of Cancer Therapy-Endocrine System (FACT-ES) scores

    FACT-ES Score measures physical, social and family, emotional, and functional well-being and endocrine symptoms. Higher scores reflect better well-being and fewer symptoms. Score range is 0 to 220. Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: From 0 to 3 months

  3. Incidence of adverse events (AEs)

    AEs will be characterized using the descriptions and grading scales of the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Higher grades indicate greater severity.

    Measured: Up to 30 days after last dose of study treatment

  4. Changes in PROMIS Emotional Distress-Anxiety Short Form (SF) 6a Score

    The Emotional Distress-Anxiety SF consists of 7 questions regarding feelings of distress/anxiety in the past 7 days. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety. Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: From 0 to 3 months

  5. Changes in PROMIS Sleep Disturbance Short Form (SF) 4a Score

    The Sleep Disturbance SF 4a is an 8-item tool with questions regarding sleep disturbance. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance. Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: From 0 to 3 months

  6. Changes in Physical Function by Grip Strength

    Grip strength will be quantitated by hand dynamometer (Jarman) at 0 and 3 months. The dominant hand will be recorded for each participant at baseline. This test involves squeezing a dynamometer for 2 to 3 seconds and then releasing. Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: At 0 and up to 3 months

  7. Changes in Alanine Aminotransferase (ALT)

    Blood samples will be obtained for testing of alanine transaminase (ALT). An increased ALT indicates a sign of liver dysfunction. Changes will be summarized by treatment arm. Data will be represented using means/medians.

    Measured: At 0, 1, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start26 Aug 2024
  3. Primary completion24 Jan 2027 (estimated)
  4. Study completion24 Jan 2027 (estimated)

Why it stopped: Accrual goal met

Resources

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06538389
Sponsor's protocol ID
23710
Other IDs
NCI-2024-05417, 23710, P30CA033572
Status last verified
Jul 2026
First submitted
16 Jul 2024
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, BRC-001 and Questionnaire Administration in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by City of Hope Medical Center 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 14 inclusion and 27 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: paused, as of the sponsor's last update on 14 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Brief Pain Inventory-Short Form (BPI-SF) score (time frame: From 0 to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06538389.

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 14 Jul 2026.

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