Safety/Efficacy of Letrozole Monotherapy or in Combination With Zoledronic Acid as Extended Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Condition: Osteoporosis; Postmenopausal
MeSH terms: Breast Neoplasms; Osteoporosis
Intervention: Letrozole; Zoledronic acid
Intervention description: 2.5 mg/day for 3 years; 4 mg every 6 months
Intervention MeSH terms: Zoledronic Acid; Letrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; postmenopausal; bone mineral density; Zoledronic acid; Letrozole; extended adjuvant treatment.; Postmenopausal women with primary hormone receptor positive breast cancer

Summary:

      This was a prospective, randomized, open-label, two arm phase III trial designed to evaluate
      the efficacy and safety of zoledronic acid in preventing bone loss in postmenopausal women
      with operable breast cancer who had received 4 to 6 years of adjuvant tamoxifen therapy after
      resection of the tumor. Patients were treated with letrozole 2.5 mg orally per day or
      letrozole 2.5 mg orally per day in combination with zoledronic acid 4 mg/6 months as an
      infusion.

      This trial did not recruit patients in the United States.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Compliant postmenopausal women with primary operable breast cancer after 4 to 6 years
             of therapy with tamoxifen (end of tamoxifen therapy within last 6 months)

          -  Performance status 0-2 (Eastern Cooperative Oncology Group)

          -  Patients without severe osteoporosis at study entry

          -  No evidence of relapse at the time of randomization

          -  Adequate function of bone marrow, kidney, and liver

        Exclusion Criteria:

          -  Estrogen- and progesterone-receptor status negative or unknown

          -  Completion of adjuvant tamoxifen therapy more than 6 months prior to study start

          -  Inflammatory breast cancer

          -  Current/active dental problems including infection of the teeth or jawbone, dental or
             fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of
             exposed bone in the mouth, or of slow healing after dental procedures.

          -  Recent (within 6 weeks) or planned dental or jaw surgery

          -  History of diseases with influence on bone metabolism such as Paget's disease and
             primary overactive parathyroid

          -  Prior or concomitant therapies: chemotherapy within the last 12 months, intravenous or
             oral bisphosphonates, systemic corticosteroids, anabolic steroids or growth hormones,
             Tibolone, parathyroid hormone, systemic sodium fluoride or any drugs known to affect
             the skeleton (such as calcitonin, mithramycin, or gallium nitrate)

          -  Patients with previous or concomitant cancers (not breast cancer) within the past 5
             years EXCEPT adequately treated basal or squamous cell skin cancers or in situ cancer
             of the cervix. Patients with previous other cancer(s) must have been disease-free for
             at least 5 years.

          -  Patients currently receiving oral bisphosphonates must discontinue these at least 3
             weeks prior to study start.

        Additional protocol defined inclusion/exclusion criteria may apply.