OncoMatch/Clinical Trials/NCT06538389
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
Is NCT06538389 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies BRC-001 for anatomic stage 0 breast cancer ajcc v8.
Treatment: BRC-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 positive
Required: PR (PGR) positive
Disease stage
Required: Stage 0, I, II, IIIA
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: aromatase inhibitor (anastrozole, letrozole, exemestane) — adjuvant endocrine therapy
Currently taking a third-generation aromatase inhibitor (AI) (e.g., anastrozole [Arimidex], letrozole [Femara], or exemestane [Aromasin]) for ≥ 90 days prior to registration with plans to continue for ≥ 180 days after registration
Must have received: definitive breast cancer surgery
Must have undergone definitive breast cancer surgery and recovered
Cannot have received: cannabinoid containing cannabis or hemp products (CBD, tetrahydrocannabinol, Marinol, Epidiolex)
< 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
Cannot have received: investigational agents
< 28 days since prior investigational agents
Cannot have received: medical therapy, alternative therapy, or physical therapy for joint pain/stiffness
Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness within the past 30 days
Cannot have received: narcotic
Narcotic use within 14 days of registration
Cannot have received: oral or intramuscular corticosteroids
Patients must not have received oral or intramuscular corticosteroids within 28 days prior to registration
Cannot have received: intra-articular steroids
Patients must not have received intra-articular steroids to the study, or any other, joint within 28 days prior to registration
Cannot have received: topical analgesics (capsaicin preparations)
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
Cannot have received: analgesics (opiates, tramadol)
Exception: NSAIDs and acetaminophen allowed
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
Lab requirements
Blood counts
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
Kidney function
Grade 3+ renal impairment
Liver function
Significantly impaired hepatic function (ALT > 5 x ULN or total bilirubin > 2 x ULN) OR the ALT or AST > 3 x ULN and TBL > 2 x ULN (or INR > 1.5)
Significantly impaired hepatic function (ALT > 5 x ULN or total bilirubin > 2 x ULN) OR the ALT or AST > 3 x ULN and TBL > 2 x ULN (or 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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