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

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Supportive care, Treatment Completed Postmenopausal Pharmaceutical / Industry D5392C00050
SABRE, NCT00082277

Trial Description

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

AstraZeneca Pharmaceuticals LP

AstraZeneca Arimidex Medical Science Director, MD

Study Director

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00082277
Information obtained from ClinicalTrials.gov on March 18, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.