Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
SABRE
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
2 other identifiers
interventional
237
8 countries
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 breast-cancer
Started Apr 2004
Typical duration for phase_4 breast-cancer
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
May 5, 2004
CompletedFirst Posted
Study publicly available on registry
May 6, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedJanuary 26, 2011
January 1, 2011
3.5 years
May 5, 2004
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
Assessed at 12 months
Secondary Outcomes (6)
Change from baseline in total hip BMD
Assessed at 12 and 24 months
Change from baseline in lumbar spine (L1-L4) BMD
Assessed at 24 months
Change from baseline in bone formation markers
Assessed at 6 and12 months
Change from baseline in bone resorption and formation markers
Assessed at 6 and 12 months
Change from baseline in LDL-cholesterol
Assessed at 12 months
- +1 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALHigh-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
2
EXPERIMENTALModerate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
3
EXPERIMENTALLow-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
Interventions
Eligibility Criteria
You may qualify if:
- Women defined as Postmenopausal
- Histologically proven operable invasive breast cancer
- Hormone-receptor-positive breast cancer
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (35)
Research Site
Palm Springs, California, 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
Raleigh, North Carolina, United States
Research Site
Cleveland, Ohio, United States
Research Site
Pittsburgh, Pennsylvania, United States
Research Site
Houston, Texas, United States
Research Site
Burnaby, Canada
Research Site
Edmonton, Canada
Research Site
Montreal, Canada
Research Site
Québec, Canada
Research Site
Vancouver, Canada
Research Site
Bordeaux, France
Research Site
Caen, France
Research Site
Lyon, France
Research Site
Saint-Cloud, France
Research Site
Saint-Herblain, France
Research Site
Athens, Greece
Research Site
Irakleio, Greece
Research Site
Goes, Netherlands
Research Site
Ijssel, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
The Hague, Netherlands
Research Site
Bloemfontain, South Africa
Research Site
Cape Town, South Africa
Research Site
Tygerberg, South Africa
Research Site
Pamplona, Spain
Research Site
Pontevedra, Spain
Research Site
Seville, Spain
Research Site
Valencia, Spain
Research Site
Belfast, United Kingdom
Research Site
Bolton, United Kingdom
Research Site
Dundee, United Kingdom
Research Site
Luton, United Kingdom
Related Publications (1)
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Arimidex Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 5, 2004
First Posted
May 6, 2004
Study Start
April 1, 2004
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
January 26, 2011
Record last verified: 2011-01