A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2049 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-01

Study Completion Date

2012-04-04

Brief Summary

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The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone metastases in subjects with advanced breast cancer.

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Detailed Description

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Conditions

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Bone Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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zoledronic acid

Group Type ACTIVE_COMPARATOR

Zoledronic Acid

Intervention Type DRUG

Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

denosumab

Group Type EXPERIMENTAL

Denosumab

Intervention Type BIOLOGICAL

Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes

Interventions

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Denosumab

Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes

Intervention Type BIOLOGICAL

Zoledronic Acid

Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC

Intervention Type DRUG

Other Intervention Names

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Zometa

Eligibility Criteria

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Inclusion Criteria

* Adults with histologically or cytologically confirmed breast adenocarcinoma
* radiographic evidence of at least one bone mets
* Easter Cooperative Oncology Group status of 0, 1 or 2;
* adequate organ function