A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer.

• Conditions: Treatment of bone metastases in subjects with advanced breast cancer.; MedDRA version: 8.1Level: LLTClassification code 10027452Term: Metastases to bone

• Registration Number: EUCTR2006-000339-93-DE
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-17
• Last Update Posted: 21 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1960

Inclusion Criteria

- Adult (men included) with histologically or cytologically confirmed breast adenocarcinoma.
- Current or prior radiographic (ie, x-ray, computer tomography [CT], or magnetic resonance imaging [MRI]) evidence of at least 1 bone metastasis.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- Adequate organ function as defined by the following criteria:
1. Serum aspartate aminotransferase (AST) less than or equal to 5 x upper limit of normal (ULN).
2. Serum alanine aminotransferase (ALT) less than or equal to 5 x ULN.
3. Serum total bilirubin less than or equal to 2 x ULN.
4. Creatinine clearance greater than or equal to 30 mL/min.
5. Albumin-adjusted serum calcium greater than or equal to 2.0 mmol/L (8.0 mg/dL) and less than or equal to 2.9 mmol/L (11.5 mg/dL). Albumin-adjusted serum calcium, if applicable, will be calculated by the central laboratory.
- Before any study-specific procedure, the appropriate written informed consent must be obtained.
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

- Current or prior IV bisphosphonate administration.
- Current or prior oral bisphosphonate treatment for bone metastasis.
- Planned radiation therapy or surgery to bone.
- Prior administration of denosumab.
- Known brain metastases.
- Life expectancy less than 6 months.
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw.
- Active dental or jaw condition which requires oral surgery.
- Non-healed dental/oral surgery.
- Planned invasive dental procedure for the course of the study.
- Evidence of any of the following conditions per subject self report or medical chart review:
1. Any prior malignancy (other than breast cancer, basal cell carcinoma, or in situ cervical cancer) with active disease within 3 years before randomization.
2. Known infection with human immunodeficiency virus.
3. Active infection with Hepatitis B or Hepatitis C virus.
- Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
- Thirty days or less since receiving an investigational product or device (ie, does not have marketing authorization) in another clinical trial.
- Subject with reproductive potential who will not agree to use effective contraception (as defined by the principal investigator or designee).
- Known sensitivity to any of the products to be administered during dosing (eg, zoledronic acid, mammalian derived products, calcium or vitamin D).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified