An open-label, randomized, multicenter safety study to evaluate the skeletal and lipid profile effects of letrozole and tamoxifen in postmenopausal women with resected, receptor positive early breast ...

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Reference: EUCTR2004-002418-12

An open-label, randomized, multicenter safety study to evaluate the skeletal and lipid profile effects of letrozole and tamoxifen in postmenopausal women with resected, receptor positive early breast cancer

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Extract

The primary objective of this study is to assess the effect of letrozole versus tamoxifen on the bone mineral density (BMD) of the lumbar spine (L2 to L4) as measured by dual energy X-ray absorptiometry (DXA) at 2 years in postmenopausal women with resected hormone receptor-positive primary breast cancer. The primary endpoint is therefore percent change from baseline in lumbar spine (L2-L4) BMD at 2 years.


Inclusion criteria

  • Bone loss attributed to cessation of ovarian estrogen production is common in postmenopausal women. In postmenopausal women with breast cancer, treatment with an aromatase inhibitor may further reduce or eliminate estrogen activity, leading to potential acceleration of bone loss. This study will evaluate the effects of letrozole and tamoxifen on bone and lipid metabolism in postmenopausal women with resected, receptor positive early breast cancer