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

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Trial Conditions
  • Breast Cancer
  • Musculoskeletal Complications
  • Pain
What is the purpose of this trial?

RATIONALE: Duloxetine hydrochloride may lessen muscle, bone, and joint pain caused by hormone therapy. It is not yet known whether duloxetine hydrochloride is more effective than a placebo in treating patients with muscle, bone, and joint pain caused by hormone therapy. PURPOSE: This randomized phase III trial studies how well duloxetine hydrochloride works compared to a placebo in treating muscle, bone, and joint pain in patients with early-stage breast cancer receiving hormone therapy.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
0 and older

Gender:
Female

Eligibility

DISEASE CHARACTERISTICS:

- Patients must be women with histologically confirmed estrogen receptor (ER)- and/or
progesterone receptor (PgR)-positive invasive carcinoma of the breast with no
evidence of metastatic disease (M0)

- Patients must have completed mastectomy or breast-sparing surgery and must have
recovered from all side effects of the surgery

- Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that
began or increased after starting AI therapy; new musculoskeletal pain must not be
due specifically to fracture or traumatic injury

- Patients must have completed the S1202 Brief Pain Inventory-Short Form (BPI-SF)
within 7 days prior to registration; patients must have an "average pain" of at least
4 on the BPI-SF

PATIENT CHARACTERISTICS:

- Patients must be post-menopausal, as defined by at least one of the following:

- At least 12 months since the last menstrual period

- Prior bilateral oophorectomy

- Previous hysterectomy with one or both ovaries left in place (or previous
hysterectomy in which documentation of bilateral oophorectomy is unavailable)
AND follicle-stimulating hormone (FSH) values consistent with the institutional
normal values for the post menopausal state; if patient is under the age of 55,
FSH levels must be obtained within 28 days prior to registration

- Patients must have Zubrod performance status of 0-2

- Patients must have no known allergy or hypersensitivity to duloxetine or any of the
inactive ingredients in the matching placebo

- Patients must not have any contraindicated concurrent illnesses listed on the
duloxetine package insert including:

- Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal
ideation, history of bipolar disorder, or seizure disorder

- History of alcohol or other substance abuse or dependence within 365 days prior
to registration

- Chronic liver disease

- End-stage renal disease

- Uncontrolled narrow-angle glaucoma

- Clinically significant coagulation disorder

- Creatinine clearance > 30 mL/min

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both within 3 x
upper limit of normal

- Total bilirubin within the upper limit of normal

- Patients must be able to complete study questionnaires in English

- Patients must not have concurrent medical/arthritic disease that could confound or
interfere with evaluation of pain or efficacy including: inflammatory arthritis
(rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis,
polymyalgia rheumatica), or cancer involving the bone

- Patients must be willing to submit blood samples for correlative studies; baseline
samples must be obtained prior to beginning protocol treatment

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- If patients were treated with chemotherapy and/or radiation therapy, these treatments
must be completed at least 28 days prior to study registration

- Concurrent bisphosphonate and trastuzumab therapies are allowed

- Patients should have recovered from all Grade 2 or higher side effects of
chemotherapy and/or radiation therapy with the exception of alopecia and peripheral
neuropathy

- Patients must currently be taking one of the following aromatase inhibitor (AI) doses
for at least 21 days, but no longer than 12 months, prior to registration and plans
to continue for at least an additional 180 days after registration

- Anastrozole (Arimidex®) 1 mg daily

- Letrozole (Femara®) 2.5 mg daily

- Exemestane (Aromasin®) 25 mg daily

- Patients must not be taking any contraindicated medications listed on the duloxetine
package insert including the following: treatment with phenothiazines, propafenone,
flecainide, or linezolid; treatment with monoamine oxidase (MAO)-inhibitor within 14
days prior to registration; or current use of anticoagulation medication (e.g.,
heparin, warfarin)

- Patients must not require selective serotonin reuptake inhibitors (SSRIs), serotonin
and norepinephirine reuptake inhibitors (SNRIs), or tricyclic antidepressants during
study participation; patients must have been able to taper and discontinue treatment
with these medications at least 7 days prior to registration; patients must not have
taken duloxetine or milnacipran within 90 days prior to registration

- Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or
pregabalin must have been taking a stable dose for at least 30 days prior to
registration

Gender: Female
Steward Physician(s)
  • N. Lynn Henry, MD, PhD
  • Anne F. Schott, MD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Saint Anne's Hospital - Recruiting
Trial Interventions
Drug
  • duloxetine hydrochloride
Other
  • placebo
For more information about this trial, contact

John L. Yang

Phone: (508) 674-5600


Physician Researcher

Investigator Name:

  • N. Lynn Henry, MD, PhD
  • Anne F. Schott, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT01598298
Volunteers:  Not Accepting Healthy Volunteers

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