Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer

Breast Cancer Clinical Trial

— SABRE  

Official title:

A Multicentre Phase III/IV Study, of the Effects of Risedronate Sodium (ACTONEL™, 35mg/Week, Oral) on Bone, in Postmenopausal Women, With Hormone-receptor-positive Early Breast Cancer, Treated With Anastrozole (ARIMIDEX™, 1mg/Day Oral) With Risk of Fragility Fracture (High-risk Fragility Fracture-open-label, Non-comparative Stratum; Moderate-risk of Fragility Fracture-randomised, Double-blind Stratum; Low-risk of Fragility Fracture - Open-label, Non-comparative Stratum)Abbreviated

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082277
• Other study ID #: D5392C00050
• Secondary ID: SABRE
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2004
• Last updated: January 25, 2011
• Start date: April 2004
• Est. completion date: October 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate safety parameters of anastrozole with regard to its potential effects on postmenopausal bone loss and on lipid profiles. This trial is conducted to investigate the effects of risedronate on BMD and on bone metabolism in postmenopausal women using anastrozole as adjuvant therapy for hormone-receptor-positive early breast cancer and who are high or moderate risk of fragility fracture. It is also conducted to determine the effects of anastrozole on bone mineral density (BMD) and on bone metabolism in women at low risk of fragility fracture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Women defined as Postmenopausal

• Histologically proven operable invasive breast cancer

• Hormone-receptor-positive breast cancer

Exclusion Criteria:

• Clinical evidence of metastatic disease

• Bilateral hip fractures or bilateral hip prosthesis

• Receiving or received in last 12 months hormonal therapy for breast cancer, bisphosphonate therapy, oestrogens

• Malabsorption syndrome

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
1mg/Day Oral
• Risedronate Sodium
35mg/week, oral

Locations

Country	Name	City	State
Canada	Research Site	Burnaby
Canada	Research Site	Edmonton
Canada	Research Site	Montreal
Canada	Research Site	Quebec City
Canada	Research Site	Vancouver
France	Research Site	Bordeaux
France	Research Site	Caen
France	Research Site	Lyon
France	Research Site	Saint-Cloud
France	Research Site	Saint-Herblain
Greece	Research Site	Athens
Greece	Research Site	Iraklion
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Goes
Netherlands	Research Site	Ijssel
Netherlands	Research Site	Nijmegen
South Africa	Research Site	Bloemfontain
South Africa	Research Site	Cape Town
South Africa	Research Site	Tygerberg
Spain	Research Site	Pamplona
Spain	Research Site	Pontevedra
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Bolton
United Kingdom	Research Site	Dundee
United Kingdom	Research Site	Luton
United States	Research Site	Cleveland	Ohio
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Palm Springs	California
United States	Research Site	Pittsburgh	Pennsylvania
United States	Research Site	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  France,  Greece,  Netherlands,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)		Assessed at 12 months	No
Secondary	Change from baseline in total hip BMD		Assessed at 12 and 24 months	No
Secondary	Change from baseline in lumbar spine (L1-L4) BMD		Assessed at 24 months	No
Secondary	Change from baseline in bone formation markers		Assessed at 6 and12 months	No
Secondary	Change from baseline in bone resorption and formation markers		Assessed at 6 and 12 months	No
Secondary	Change from baseline in LDL-cholesterol		Assessed at 12 months	No
Secondary	Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides		Assessed at 3, 6 and 12 months	No