Indiana University
The purpose of this study is to evaluate the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.
Aromatase Inhibitor (AI) therapy is highly effective for post-menopausal, estrogen receptor (ER) positive breast cancer, yet the clinical effectiveness of AI therapy is limited by noncompliance and early treatment discontinuation due to musculoskeletal side effects, which include joint pain, joint stiffness, bone pain, muscle weakness, and myalgias. Methods to improve compliance to AI therapy have the potential to increase survival. This study will look at hydroxychloroquine (HCQ), a disease-modifying antirheumatic drug (DMARD) with well-established anti-inflammatory and immunomodulatory prop…
Inclusion Criteria: 1. Age ≥ 18 years at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Diagnosis of DCIS or stage I, II, or III breast cancer 4. Currently receiving adjuvant aromatase inhibitor therapy (anastrozole, letrozole or exemestane) for ≥ 4 weeks prior to enrollment Note: Concurrent use of ovarian suppression is allowed Note: Concurrent use of CDK4/6 inhibitors is not allowed due to cytopenia risk 5. New or worsening self-reported musculoskeletal pain that began or significantly worsened after initiation of AI therapy 6. BPI ave…
Drug: Hydroxychloroquine sulfate Dose: 400 mg orally once daily Duration: 12 weeks
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