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

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.

PRIMARY OBJECTIVE: I. 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: I. 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: I. 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.