SWOG 1202: 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

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.
Cancer () - Breast
Gary Goodman, M.D.
Swedish Cancer Institute
  • 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 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
  • 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 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
(206) 215-3086