At a glance
ClinicalIndex Comparison Record- ✓Stage I-IIIa breast cancer
- ✓Postmenopausal or recently postmenopausal status
- ✓Recent surgery for breast cancer completed
- ✓Estrogen Receptor positive and/or progesterone receptor positive tumor
- ✕Metastatic disease (Stage IV)
- ✕Invasive bilateral breast disease
- ✕Clinical or radiological evidence of existing fracture in spine or hip
- ✕Prior IV bisphosphonate therapy within past 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Randomized, MultiCenter Study to Evaluate the Use of Zolendronic Acid in the Prevention of Cancer Treatment-Related Bone Loss in Postmenopausal Women With Estrogen Positive and/or Progesterone Positive Breast Cancer Receiving Letrozole as Adjuvant Therapy
In Brief
A Phase 3 clinical trial evaluating Zoledronic acid and Letrozole for Bone Loss and Breast Cancer. Completed, enrolled 1,065 participants across 106 sites in 28 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
Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.
Letrozole tablets 2.5 mg/day taken orally for 5 years.