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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Anastrozole; Drug: Risedronate Sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00082277

SABRE

D5392C00050

Details and patient eligibility

About

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.

Enrollment: 237 patients

Sex: Female

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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237 participants in 3 patient groups

1

Experimental group

Description:

High-Risk Fragility Fracture-Open-Label, Non-Comparative Stratum

Treatment:

Drug: Risedronate Sodium

Drug: Anastrozole

2

Experimental group

Description:

Moderate-Risk of Fragility Fracture-Randomised, Double-Blind Stratum

Treatment:

Drug: Risedronate Sodium

Drug: Anastrozole

3

Experimental group

Description:

Low-Risk of Fragility Fracture - Open-Label, Non-Comparative Stratum

Treatment:

Drug: Risedronate Sodium

Drug: Anastrozole