Status:
COMPLETED
Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1 year with a standard zoledronic acid regimen. Looking at the continued effectiveness and safety of giving z...
Eligibility Criteria
Inclusion
- Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of 9 doses;
Exclusion
- Abnormal kidney function determined by serum creatinine levels. Current active dental problems including: ongoing infection of the teeth or jawbone; current exposed bone in the mouth; and current or prior diagnosis of osteonecrosis of the jaw.
- Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).
- Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of bone).
- Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days prior to randomization.
- Other protocol-defined exclusion criteria may have applied.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
416 Patients enrolled
Trial Details
Trial ID
NCT00320710
Start Date
February 1 2006
End Date
July 1 2013
Last Update
August 22 2014
Active Locations (92)
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1
Providence Alaska Medical Center Cancer Research
Anchorage, Alaska, United States, 99508
2
Heritage Physicians Group Oncology
Hot Springs, Arkansas, United States, 71913
3
The Center for Chest Care
Springdale, Arkansas, United States, 72764
4
Pacific Cancer Medical Center, Inc.
Anaheim, California, United States, 92801