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

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.