UNASSIGNED: This phase II trial evaluated clinical markers of efficacy and safety of @entity17082 in postmenopausal @entity1 at increased risk for @entity0 . Postmenopausal @entity1 (n=42) at risk for @entity0 received 25mg @entity17082 daily for two years along with @entity460 and @entity560 . The primary outcome was change in @entity14220 ( @entity14220 ) after one year. Secondary outcomes included change in serum @entity479 hormones as well as change in trefoil protein 1 ( @entity3559 ) and @entity1364 ( @entity1364 ) in breast tissue. Safety and tolerability were also assessed. @entity14220 decreased at 1 year and was significant at 2 years (mean change = -4.1%; 95% CI -7.2, -1.1; p = .009). Serum @entity53 and @entity251 levels significantly decreased at three months and remained suppressed at 12 months. After 1 year of treatment, @entity3559 intensity decreased (mean change -1.32; 95% CI -1.87 to -0.76; p < 0.001). @entity17082 was safe and well tolerated. @entity17082 decreased @entity14220 and expression of breast tissue @entity3559 . It was well tolerated with few clinically relevant side effects. @entity14220 and breast tissue @entity3559 are potential biomarkers of @entity0 preventive effects of @entity17082 in high-risk postmenopausal @entity1 .

XXXX use in postmenopausal @entity1 at high risk for @entity0 : evaluating biomarkers of efficacy and safety.

@entity1 :: ('9606', 'Species') :: ['women'] @entity251 :: ('MESH:D013739', 'Chemical') :: ['testosterone'] @entity1364 :: ('5111', 'Gene') :: ['proliferating cell nuclear antigen', 'PCNA'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer', 'invasive breast cancer'] @entity14220 :: ('MESH:C564595', 'Disease') :: ['MD', 'mammographic density'] @entity53 :: ('MESH:D004958', 'Chemical') :: ['estradiol'] @entity17082 :: ('MESH:C056516', 'Chemical') :: ['Exemestane', 'exemestane'] @entity460 :: ('MESH:D002118', 'Chemical') :: ['calcium'] @entity479 :: ('D013256', 'Chemical') :: ['steroid'] @entity3559 :: ('7031', 'Gene') :: ['TFF1'] @entity560 :: ('MESH:D014807', 'Chemical') :: ['vitamin D']
@entity17082 :: (MESH:C056516,Chemical) :: ['Exemestane']
