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

January 25, 2011 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
Drug: Anastrozole
1mg/Day Oral
Other Names:
  • ZD1033
  • ARIMIDEX™
Drug: Risedronate Sodium
35mg/week, oral
Other Names:
  • ACTONEL™
EXPERIMENTAL: 2
Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum
Drug: Anastrozole
1mg/Day Oral
Other Names:
  • ZD1033
  • ARIMIDEX™
Drug: Risedronate Sodium
35mg/week, oral
Other Names:
  • ACTONEL™
EXPERIMENTAL: 3
Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum
Drug: Anastrozole
1mg/Day Oral
Other Names:
  • ZD1033
  • ARIMIDEX™
Drug: Risedronate Sodium
35mg/week, oral
Other Names:
  • ACTONEL™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD)
Time Frame: Assessed at 12 months
Assessed at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in total hip BMD
Time Frame: Assessed at 12 and 24 months
Assessed at 12 and 24 months
Change from baseline in lumbar spine (L1-L4) BMD
Time Frame: Assessed at 24 months
Assessed at 24 months
Change from baseline in bone formation markers
Time Frame: Assessed at 6 and12 months
Assessed at 6 and12 months
Change from baseline in bone resorption and formation markers
Time Frame: Assessed at 6 and 12 months
Assessed at 6 and 12 months
Change from baseline in LDL-cholesterol
Time Frame: Assessed at 12 months
Assessed at 12 months
Change from baseline in LDL-cholesterol, HDL-cholesterol, total cholesterol, and serum triglycerides
Time Frame: Assessed at 3, 6 and 12 months
Assessed at 3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

May 5, 2004

First Submitted That Met QC Criteria

May 5, 2004

First Posted (ESTIMATE)

May 6, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2011

Last Update Submitted That Met QC Criteria

January 25, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5392C00050
  • SABRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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