Status:
COMPLETED
The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Breast Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Metastatic breast cancer patients with bone involvement who are at high-risk of subsequent skeletal related event (SRE), defined as radiotherapy or surgery to the bone, pathological fracture, spinal c...
Detailed Description
This study will be a prospective, randomized, double-blind, placebo controlled, Phase IV study of pamidronate vs. zoledronic acid in women with breast cancer and bone metastases. Patients who are at h...
Eligibility Criteria
Inclusion
- Metastatic breast cancer to the bone with radiologically confirmed bone metastases
- High-risk of subsequent SRE as reflected through either: elevated serum CTX (\> 400ng/L) and/or bone pain (using BPI) and/or prior SRE while on bisphosphonate therapy and/or progressive bone metastasis (by imaging)
- On pamidronate therapy for at least 3 months
- ECOG ≤ 2 and life expectancy \> 3 months
- Serum creatinine ≤ 2.0 × ULN (zoledronic acid or pamidronate to be renal dosed as per institution standard)
- No changes in systemic treatment in the 4 weeks prior to study entry or anticipated changes in the 4 weeks after entering the study. Markers of bone formation can be affected by a change in systemic therapies
- Ability to take calcium and Vitamin D as per Health Canada recommended daily doses for the duration of the study
- Ability to provide informed consent and complete study evaluations.
Exclusion
- Patients with acute symptomatic pathological fractures or acute spinal cord compression until such time as the appropriate management (surgery and/or radiotherapy) has been completed
- Acute hypercalcemia (\>3.5 mmol/L)
- Hypersensitivity to any bisphosphonate
- Patients with rapidly progressive non-bone metastases for whom delaying a change in systemic anti-cancer treatment for the 1 month biochemical marker evaluation period could have a detrimental impact on patient outcome.
- Renal dysfunction (≥ 2x creatinine of the upper limit of normal )
- Pregnancy or lactation
- Patients with dental abscesses or patients potentially requiring tooth extraction while on study
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01907880
Start Date
August 1 2012
End Date
January 1 2016
Last Update
July 7 2017
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6