NCT01298362

Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer

Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer in Real World Clinical Settings in Greece

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 290 (actual)
• Sponsor: Hellenic Breast Surgeons Society · Academic / Other
• Sex: Female
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify the combined impact on bone loss as well as the incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast cancer treated with an aromatase inhibitor (AI) either as first line therapy or as maintenance therapy after initial treatment with chemotherapy, in real life clinical settings in Greece.

Detailed description

Subjects with ER-positive early breast cancer will be treated with AIs either as first line therapy or as maintenance therapy after initial treatment with chemotherapy. The total study duration will be 24 months comprising of a recruitment period of 12 months and a follow-up period of 12 months for each participating subject. The primary outcome variable is the mean percentage variation in lumbar spine (LS) bone mineral density (BMD) during the 12 month follow - up period. Measurements will be taken before and after chemotherapy and at the end of the 12 month follow - up period.

Conditions

• Breast Cancer
• Other Disorders of Bone Density and Structure

Interventions

Type	Name	Description
DRUG	Aromatase Inhibitors
DRUG	Chemotherapy

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2011-02-17
• Last updated: 2016-09-20
• Results posted: 2016-09-20

Locations

1 site across 1 country: Greece