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
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Anastrozole
Drug: Risedronate Sodium
Phase 4

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The change from baseline in lumbar spine (L1-L4) bone mineral density (BMD) [ Time Frame: Assessed at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 237
Study Start Date: April 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum
Drug: Anastrozole
1mg/Day Oral
Other Names:
  • ARIMIDEX™
  • 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 Names:
  • ARIMIDEX™
  • 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 Names:
  • ARIMIDEX™
  • ZD1033
Drug: Risedronate Sodium
35mg/week, oral
Other Name: ACTONEL™

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082277

  Show 35 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Arimidex Medical Science Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: Francisco Sapunar, MD - Arimidex Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00082277     History of Changes
Other Study ID Numbers: D5392C00050, SABRE
Study First Received: May 5, 2004
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
hormone-receptor positive, breast cancer
Osteopenia
Osteoporosis
risk of fracture
bone loss

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Risedronic acid
Etidronic Acid
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014