SWOG clinical trial number
S1202

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of Aromatase Inhibitor (AI)-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer

Closed
Phase
III
Accrual
100%
Published
Abbreviated Title
Ph III Study of Duloxetine for AI-associated musculoskleteal symptoms for Early Stage BrCa
Status Notes
This protocol will be permanently closed to accrual effective 10/1/15.
Activated
05/15/2013
Closed
10/01/2015
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Symptom Control and Quality of Life
Breast Cancer

Treatment

Placebo Duloxetine

Eligibility Criteria Expand/Collapse

Women with histologically confirmed estrogen receptor (ER) and/or progresterone receptor (PgR) positive invasive carcinoma of the breast with no evidence of metastatic disease (Stage I-III); must have completed mastectomy or breast sparing surgery and must have recovered from all side effects of surgery. If treated with chemo or radiation therapy, treatments must be completed > 28 days prior to registration and recovered from all Grade 2 or higher side effects with the exception of alopecia and peripheral neuropathy. Concurrent bisphosphonate and trastuzumab therapies allowed; must be post-menopausal as defined by one of the following: >/= 12 months since last menstrual period, prior bilateral oophorectomy, or previous hysterectomy with one or both ovaries left in place AND (unless >/= 60 years of age) FSH values consistent with institutional values for post menopausal state; must be taking the following AI and doses for > 21 days, but < 36 months, prior to registration with plans to continue > 180 after registration: anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily; must have AI assosicated musculoskeletal symptoms that began or increased after starting AI therapy. New musculoskeletal pain must not be due specifically to fracture or traumatic injury; must have completed S1202 Brief Pain Inventory-Short Form within 7 days prior to registration and have �average pain� of at least 4 on item #4; Zubrod PS 0-2; no known allergy or hypersensitivity to duloxetine or any inactive ingredients in matching placebo; must not have contraindicated concurrent illnesses listed on duloxetine package insert including: current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history or bipolar disorder, or seizure disorder, history of alcohol or other substance abuse or dependence < 365 prior to registration, chronic liver disease, end stage renal disease, uncontrolled narrow-angle glaucoma, clinically significant coagulation disorder; must not take MAO-Inhibitors for 14 days prior to reg or during study treatment, concomitant therapy with heparin and warfarin is not permitted; calculated creatinine clearance > 30 mL/min within 28 days prior to registration; AST and ALT both within 3 x Upper Limit of Normal; total bilirubin within upper limit of normal; must not require selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants during study participation. Patients must have been able to taper and discontinue treatment with these medications > 7 days prior to registration (28 days for fluoxetine), and must not be experiencing antidepressant withdrawal symptoms. Must not have previously taken the serotonin norepinephrine reuptake inhibitors (SNRI) duloxetine or milnacipran. Prior venlafaxine is allowed as long as it was not taken for treatment of pain. NOTE: Patients requiring antidepressants for management of depression are not appropriate candidates for this placebo-controlled study, but those who are on antidepressants for other indications (such as hot flash management) may be able to tolerate a time off of antidepressant therapy; if receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin, must be taking a stable dose for at least 30 days prior to registration; must be able to complete study questionnaires in English; must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis and cancer involving the bone. Patients may have osteoarthritis; must be willing to submit blood samples for correlative studies

Publication Information Expand/Collapse

2018

Randomized Multicenter Placebo-Controlled Clinical Trial of Duloxetine versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early Stage Breast Cancer: SWOG S1202

NL Henry;JM Unger;AF Schott;L Fehrenbacher;PJ Flynn;DM Prow;CW Sharer;GV Burton;CS Kuzma;A Moseley;DL Lew;MJ Fisch;CM Moinpour;DL Hershman;JL Wade Journal of Clinical Oncology Feb 1;36(4):326-332

PMid: PMID29136387 | PMC number: PMC5805479

2016

Randomized, placebo controlled trial of duloxetine for aromatase inhibitor (AI)associated musculoskeletal symptoms (AIMSS) in early stage breast cancer (SWOG 1202)

NL Henry;J Unger;A Schott;L Fehrenbacher;P Flynn;D Prow;C Sharer;D Lew;A Moseley;M Fisch;C Moinpour;J Wade San Antonio Breast Cancer Symposium (December 6-10, 2016, San Antonio, TX), oral

2014

A Randomized Placebo-Controlled Phase III Study of Duloxetine for Treatment of AromataseInhibitor (AI)-Associated Musculoskeletal Symptoms in Women with Early Stage Breast Cancer: SWOG S1202

NL Henry;J Unger;A Schott;L Hansen;D Lew;J Wade;C Moinpour;GN Hortobagyi;FL Meyskens Journal of Clinical Oncology 32:5s (suppl; abstr TPS9662); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), general poster session;

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SWOG Clinical Trial Number
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Research Committee(s)
Breast Cancer
Activated
01/09/1975
Closed
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Accrual
100%
Closed
Phase
III
Published
SWOG Clinical Trial Number
SWOG-7827

Combined Modality Therapy For Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
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Closed
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Accrual
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Phase
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