Status: Closed
Activation Date: 2006APR24
Closing Date: 2008MAY30
Phase: III
Description: The Influence of Five Years of Adjuvant Anastrozole or Exemestane on Bone Mineral Density in Postmenopausal Women with Primary Breast Cancer - A Companion Study to MA.27
Eligibility: MA.27 patients who have a bone mineral density measurement (using DEXA: dual energy x-ray absorptiometry) done within 12 weeks prior to randomization to the MA.27 core protocol may participate in the companion protocol. In order to be eligible patients must not have malabsorption syndrome, clinically relevant vitamin D deficiency, active hyper- or hypoparathyroidism, Paget's disease, uncontrolled thyroid disease, Cushing's disease, other pituitary diseases, or other bone diseases. Patients must not have received previous treatment with anticonvulsants or anabolic steroids within the past 12 months, high doses of corticosteroids or sodium fluoride for an extended time or be on long term treatment with coumarins
Objective: The primary objective is to examine whether there is a clinically relevant difference in impact on BMD between the steroidal (exemestane) and the non-steroidal (anastrozole) agents at 2 years
Participation: Limited to MA.27 participants
Lay Description: After menopause, the strength of the bones slowly declines. One of the reasons it declines is because estrogen levels have also declined. The purpose of this "companion study" is to evaluate the possible additional effects of anastrozole or exemestane on the thinning of bones (osteoporosis). Bone "density" will be measured prior to MA.27 treatment and annually while on MA.27 study treatment
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
BREAST | MA27B | 497 | 0 | 0 | 0 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
BREAST | MA27B | 497 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
BREAST | MA27B | 497 | 0 | 0 | 0 | 0 | 0 | 430 | 0 | 0 |