A randomised active controlled study of AMG 162 in breast cancer subjects with bone metastases who have not previously been treated with bisphosphonate therapy

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 240

Inclusion Criteria

Histologically or cytologically confirmed breast adenocarcinomas
Radiographic evidence of at least 1 bone metastases
Female at least 18 years old
ECOG SCORE (0, 1, or 2)
Adequate organ function as defined as follows:
- serum aspartate aminotransferase (AST: serum glutamate-oxalate transferase (SGOT) and serum alanine aminotransferase (ALT; SGPT) less than or equal to 2.5 times the ULN
- if liver function abnormalities are due to the underlying malignancy, then AST and ALT must be less than 5 times the ULN
- total serum bilirubin is less than or equal to 1.5 times the ULN
- absolute neutrophil count (ANC) is greater or equal to 1.5 times 10*9/L
- platelets is greater or equal to 100 times 10*9 /L
- hemoglobin is greater or equal to 9.0 g/dL
- albumin-adjusted serum calcium is greater 2 times ULN
- serum creatinine is less than or equal to 2.0 times ULN
Concurrent chemotherapy or hormonal therapy for metastatic breast cancer is allowed during study treatment if no changes in regimens or agents are planned during the first 3 months on study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unresolved toxicities greater than grade 2 from prior anti-cancer therapy, excluding apocepia
Presence of untreated or symptomatic brain metastases
Current or prior (IV or oral) bisphosphonate administration
Administration of OPG construct ( ie AMGN-007, Fc-OPG or AMG 162)
Administration of calcitonin, PTH, mithramycin, strontium rannelate, gallium nitrate within 8 weeks prior to randomisation
Current therapy with chronic system corticosteroid administration, equal to or greater than 5 mg/day prednisolone or equivalent daily
Evidence of impending fracture in weight bearing bones
Radiation therapy to bone within 2 weeks before randomisation
Treatment with radioisotopes detected to bone within 8 weeks before randomisation
Evidence of any of the following conditions:
- current hyper or hypothyroidism
- Pagets disease, hyperprolactinemia or chronic liver disease
- Prior malignancy
- unstable systemic diseases includinh active infection, incontrolled hypertension, unstable angina, congestive heart failure or myocardial infection within 6 months of randomisation
- major surgery, or significant traumatic injury occuring within 4 weeks before randomisation.
- known HIV infection
-

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of different doses and schedules of AMG 162 on the percent change from baseline in urinary N-telopeptide (uNTx) at week 13;Secondary Objective: To characterise the safety profile of AMG 162 administered subcutaneously (SC) at 30 mg, 120 mg, or 180 mg every q4 weeks or 60 mg or 180 mg every q 12 weeks<br><br>To evaluate the pharmacokinetic parameters of AMG 162 at different doses and schedules;Primary end point(s): The primary efficacy endpoint is the percentage change from baseline to week 13 in uNTx. This change is defined as (wk 13 uNTx- baseline uNTx) Baseline uNTx

Secondary Outcome Measures

Name	Time	Method

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