An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.

Official Title
-----------------
An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice

Conditions
-----------------
Breast Cancer, Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 55-65 years, diagnosed with invasive early breast cancer: - Surgery, chemo- and/or radiotherapy concluded less than 6 months ago Women with hormone-independent breast cancer: - Surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months Women with hormone-dependent breast cancer:- Adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - Adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - Switch from tamoxifen to aromatase inhibitor initiated before 24-36 months Exclusion Criteria: Women receiving active treatment for osteoporosis Women with any evidence of breast cancer recurrence

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A:<br>70 women with hormone-dependent or hormone-independent early breast cancer that have completed their chemo- and/or radiotherapy just recently (up to 6 months after completion of therapy) | |
| B<br>70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy | |
| C<br>70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy | |
| D<br>70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy | |
| E<br>70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy | |
| F<br>70 women with hormone-dependent early breast cancer, 54-66 months after initiation of tamoxifen therapy | |
| G<br>70 women with hormone-dependent early breast cancer, 54-66 months after initiation of aromatase inhibitors therapy | |
| H<br>70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy following 24-36 months of initial tamoxifen therapy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effect of aromatase inhibitors therapy on bone mineral density as measured by DEXA scan and compare it to the effects of tamoxifen and no hormonal therapy. |  | once | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the bone fracture rate in women on aromatase inhibitors therapy and compare it to fracture rates observed in the tamoxifen and the hormone-independent group. |  | once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, aromatase inhibitors, bone mineral density, osteoporosis