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

NCT06538389 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 23710NCI-2024-05417P30CA033572
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Breast Adenocarcinoma; Breast Ductal Carcinoma In Situ; Estrogen Receptor-Positive Breast Carcinoma; Progesterone Receptor-Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (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.

  From 0 to 3 months

Secondary Outcomes (7)

• Changes in Visual Analog Scale (VAS) for Pain

  From 0 to 3 months

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

  From 0 to 3 months

• Incidence of adverse events (AEs)

  Up to 30 days after last dose of study treatment

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

  From 0 to 3 months

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

  From 0 to 3 months

Study Arms (2)

Arm I (BRC-001)

EXPERIMENTAL

Participants 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.

Procedure: Biospecimen Collection; Drug: BRC-001; Other: Questionnaire Administration

Arm II (Placebo)

PLACEBO COMPARATOR

Placebo 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.

Procedure: Biospecimen Collection; Drug: Placebo Administration; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (BRC-001); Arm II (Placebo)

BRC-001 DRUG

Given PO

Also known as: Cannabidiol, CBD, CBD Oil

Arm I (BRC-001)

Placebo Administration DRUG

Given PO

Arm II (Placebo)

Questionnaire Administration OTHER

Ancillary studies

Arm I (BRC-001); Arm II (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• \< 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator
• Biopharmaceutical Research Company: collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Specimen Handling; Cannabidiol

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Lisa D Yee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 5, 2024
• Study Start: August 26, 2024
• Primary Completion (Estimated): January 24, 2027
• Study Completion (Estimated): January 24, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)