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

Amgen

Status and phase: Completed; Phase 3

Conditions: Bone Metastases

Treatments: Drug: Zoledronic Acid; Biological: Denosumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00321464

20050136

Details and patient eligibility

About

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.

Enrollment: 2,049 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Current or prior IV bisphosphonate administration
• current or prior oral bisphosphonates for bone mets
• life expectancy of less than 6 months

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,049 participants in 2 patient groups

zoledronic acid

Active Comparator group

Treatment:

Drug: Zoledronic Acid

denosumab

Experimental group

Treatment:

Biological: Denosumab