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
- Bone metastases in advanced breast cancer. Breast cancer spread to bone.1000595910040778
- Registration Number
- NL-OMON31822
- Lead Sponsor
- AMGEN Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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 of 0, 1, or 2
* adequate organ function as defined by the following criteria:
* serum aspartate aminotransferase (AST) less than or equal to 5 x upper limit of normal (ULN)
* serum alanine aminotransferase (ALT) less than or equal to 5 x ULN
* serum total bilirubin less than or equal to 2 x ULN
* creatinine clearance (Cockcroft-Gault) equal or higher to 30 mL/min
* albumin-adjusted serum calcium equal or higher to 2.0 mmol/L (8.0 mg/dL) and less than or equal to 2.9 mmol/L (11.5 mg/dL)
* Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.
Exclusion Criteria:
* current or prior IV bisphosphonate administration
* current or prior oral bisphosphonate for the treatment of 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 that requires oral surgery
* non-healed dental/oral surgery
* planned invasive dental procedure over the course of the study
* evidence of any of the following conditions per subject self report or medical chart review:
* any prior malignancy (other than breast cancer, basal cell carcinoma or in situ cervical cancer) with active disease within 3 years before randomization
* known infection with human immunodeficiency virus
* active infection with Hepatitis B virus 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 the study (eg, zoledronic acid, mammalian derived products, calcium or vitamin D)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to the first on-study SRE (non-inferiority)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Efficacy Endpoints<br /><br>* time to the first on-study SRE (superiority)<br /><br>* time to the first-and-subsequent on-study SRE (superiority, using multiple<br /><br>event analysis)<br /><br>Safety Endpoints<br /><br>* subject incidence of treatment-emergent adverse events<br /><br>* changes in laboratory values<br /><br>* Incidence of anti-denosumab antibody (binding and neutralizing) formation</p><br>