At a glance
ClinicalIndex Comparison Record- ✓Female sex
- ✓Postmenopausal status: >12 months amenorrhea, history of oophorectomy, ≥55 years with hysterectomy/cyclic HRT, or ages 50-54 with documented FSH/LH values
- ✓Histologically confirmed resected breast cancer
- ✓Hormone receptor-positive tumor: ER and/or PgR ≥10 fmol/mg cytosol or ≥10% by immunocytochemistry
- ✕Distant metastases
- ✕Pre-existing bone disease (osteomalacia, osteogenesis imperfecta, Paget's disease)
- ✕Bisphosphonate use for >3 months before randomization
- ✕Anticonvulsants within past year
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study to Evaluate the Effect of Letrozole and Tamoxifen on Bone and Lipids in Postmenopausal Women With Breast Cancer
In Brief
A Phase 3 clinical trial evaluating Letrozole and Tamoxifen for Hormone Sensitive Resected Primary Breast Cancer in Postmenopausal Women. Completed, enrolled 263 participants across 13 sites in 2 countries.
Detailed Summary
Estrogen is known to be a regulator of bone and lipid metabolism. Letrozole is a potent inhibitor of estrogen synthesis. This study evaluated the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer.
Study Details
Timeline
Interventions
2.5 mg tablets and supplied in bottles with 6-monthly supplies.
20 mg tablets in bottles as 6-monthly supplies (supplied to Novartis as Tamofen from Schering Oy, Subsidiary of Schering AG, Pansiontie 47, FIN-2010 Turku, Finland)