At a glance
ClinicalIndex Comparison Record- ✓Stage I–IIIa breast cancer
- ✓Postmenopausal status
- ✓Recent surgery for breast cancer
- ✕Metastatic disease
- ✕Invasive bilateral breast disease
- ✕Clinical or radiological evidence of existing fracture in spine or hip
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Zoledronic acid and Letrozole for Breast Cancer. Completed, enrolled 527 participants across 49 sites in 9 countries.
Detailed Summary
Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
Study Details
Timeline
Interventions
Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.
Letrozole tablets 2.5 mg/day/taken orally for 5 years.