Anastrozole Biphosphonate Study in Postmenopausal Women with Hormone-Receptor-Positive Early Breast Cancer - SABRE
Study identifier:D5392C00050
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Breast Cancer
Phase
Phase 4
Healthy volunteers
No
Study drug
Anastrozole, Risedronate Sodium
Sex
Female
Actual Enrollment
237
Study type
Interventional
Age
55 Years +
Date
Study Start Date: 01 Apr 2004
Primary Completion Date: 01 Oct 2007
Study Completion Date: 01 Oct 2007
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum | Drug: Anastrozole 1mg/Day Oral Other Name: ARIMIDEX™ Other Name: ZD1033 Drug: Risedronate Sodium 35mg/week, oral Other Name: ACTONEL™ |
| Experimental: 2 Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum | Drug: Anastrozole 1mg/Day Oral Other Name: ARIMIDEX™ Other Name: ZD1033 Drug: Risedronate Sodium 35mg/week, oral Other Name: ACTONEL™ |
| Experimental: 3 Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum | Drug: Anastrozole 1mg/Day Oral Other Name: ARIMIDEX™ Other Name: ZD1033 Drug: Risedronate Sodium 35mg/week, oral Other Name: ACTONEL™ |
Contacts
Investigators
Principal Investigator
AstraZeneca Arimidex Medical Science Director
AstraZeneca
