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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00082277
First received: May 5, 2004
Last updated: January 25, 2011
Last verified: January 2011

May 5, 2004
January 25, 2011
April 2004
October 2007   (final data collection date for primary outcome measure)
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00082277 on ClinicalTrials.gov Archive Site
  • Change from baseline in total hip BMD [ Time Frame: Assessed at 12 and 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in lumbar spine (L1-L4) BMD [ Time Frame: Assessed at 24 months ] [ Designated as safety issue: No ]
  • Change from baseline in bone formation markers [ Time Frame: Assessed at 6 and12 months ] [ Designated as safety issue: No ]
  • Change from baseline in bone resorption and formation markers [ Time Frame: Assessed at 6 and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-cholesterol [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides [ Time Frame: Assessed at 3, 6 and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Anastrozole Biphosphonate Study in Postmenopausal Women With Hormone-Receptor-Positive Early Breast Cancer
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Anastrozole
    1mg/Day Oral
    Other Names:
    • ARIMIDEX™
    • ZD1033
  • Drug: Risedronate Sodium
    35mg/week, oral
    Other Name: ACTONEL™
  • Experimental: 1
    High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
    Interventions:
    • Drug: Anastrozole
    • Drug: Risedronate Sodium
  • Experimental: 2
    Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
    Interventions:
    • Drug: Anastrozole
    • Drug: Risedronate Sodium
  • Experimental: 3
    Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
    Interventions:
    • Drug: Anastrozole
    • Drug: Risedronate Sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Female
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Greece,   Netherlands,   South Africa,   Spain,   United Kingdom
 
NCT00082277
D5392C00050, SABRE
Not Provided
Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP