Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

Amgen

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Bone Metastases in Subjects With Advanced Breast Cancer; Metastases

Treatments: Biological: Denosumab; Drug: IV Bisphosphonates

Study type: Interventional

Funder types: Industry

Identifiers

NCT00091832

20040113

Details and patient eligibility

About

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.

Enrollment: 255 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma

• At least one bone metastasis

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

255 participants in 6 patient groups

Denosumab 60 mg every 12 weeks

Experimental group

Description:

Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.

Treatment:

Biological: Denosumab

Denosumab 120 mg every 4 weeks

Experimental group

Description:

Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Treatment:

Biological: Denosumab

Denosumab 180 mg every 4 weeks

Experimental group

Description:

Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Treatment:

Biological: Denosumab

IV bisphosphonates every 4 weeks

Active Comparator group

Description:

Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion for 25 weeks.

Treatment:

Drug: IV Bisphosphonates

Denosumab 180 mg every 12 weeks

Experimental group

Description:

Denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks.

Treatment:

Biological: Denosumab

Denosumab 30 mg every 4 weeks

Experimental group

Description:

Denosumab 30 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks.

Treatment:

Biological: Denosumab