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

AstraZeneca

Status: Completed

Conditions: Osteoporosis; Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT00767585

NIS-OSI-DUM-2008/1

Details and patient eligibility

About

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.

Enrollment: 560 estimated patients

Sex: Female

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

560 participants in 8 patient groups

A:

Description:

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

Description:

70 women with hormone-independent early breast cancer, 24-36 months after completion of chemo- and/or radiotherapy

C

Description:

70 women with hormone-independent early breast cancer, 54-66 months after completion of chemo- and/or radiotherapy

D

Description:

70 women with hormone-dependent early breast cancer, 24-36 months after initiation of tamoxifen therapy

E

Description:

70 women with hormone-dependent early breast cancer, 24-36 months after initiation of aromatase inhibitors therapy

F

Description:

70 women with hormone-dependent early breast cancer, 54-66 months after initiation of tamoxifen therapy

G

Description:

70 women with hormone-dependent early breast cancer, 54-66 months after initiation of aromatase inhibitors therapy

H

Description:

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