Cancer

Title
Study to Compare the Effects of the Medication Duloxetine with a Placebo on Joint Pain from Aromatase Inhibitors for Hormone Receptor Positive Breast Cancer.
Trial Number
205995011514
Number of Participants
294
Principal Investigator
Eligibility

Patients with the following criteria may be eligible:
• Women with histologically confirmed hormone receptor positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)
• Completed mastectomy or breast-sparing surgery
• Postmenopausal
• Must currently be taking an aromatase inhibitor for at least 21 days, but no longer than 36 months
• Must have aromatase-inhibitor-associated musculoskeletal symptoms that began or increased after starting AI therapy
• ECOG PS of 0-2 with good organ function
• Must not require SSRIs or SNRIs
• Must not have a current primary psychiatric diagnosis, suicidal ideation, history of bipolar disorder, seizure disorder, alcohol or other substance abuse or dependence
• Must not have uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder

Purpose

The goal of this study is to assess the effects, good and/or bad, of the medication duloxetine compared with a placebo (contains no active ingredient) on joint pain that is associated with taking aromatase inhibitors.

Enrollment

(708) 327-3105

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