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

Patricia Robinson

M.D.
Hematology/Oncology
Assistant Professor
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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