Breast Cancer | The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer
Breast Cancer research study
What is the primary objective of this study?
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 cord compression, or hypercalcemia (as reflected through: elevated sCTX or bone pain or a prior SRE despite receiving standard bisphosphonate therapy) should experience a decrease in the surrogate marker, sCTX, at week 12 if switched to zoledronic acid compared with those patients who continue on intravenous pamidronate (i.e. current standard of care). The investigators propose that a drop in sCTX will correlate with improved pain, quality of life and a reduced incidence of further SREs.
Who is eligible to participate?
Inclusion Criteria: 1. Metastatic breast cancer to the bone with radiologically confirmed bone metastases 2. 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) 3. On pamidronate therapy for at least 3 months 4. ECOG ≤ 2 and life expectancy > 3 months 5. Serum creatinine ≤ 2.0 × ULN (zoledronic acid or pamidronate to be renal dosed as per institution standard) 6. 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 7. Ability to take calcium and Vitamin D as per Health Canada recommended daily doses for the duration of the study 8. Ability to provide informed consent and complete study evaluations. Exclusion Criteria: 1. 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 2. Acute hypercalcemia (>3.5 mmol/L) 3. Hypersensitivity to any bisphosphonate 4. 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. 5. Renal dysfunction (≥ 2x creatinine of the upper limit of normal ) 6. Pregnancy or lactation 7. Patients with dental abscesses or patients potentially requiring tooth extraction while on study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Pamidronate90mg IV once every 4 weeks for 3 cycles
Drug:Zoledronic acid4mg IV every 4 weeks for 3 cycles
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Pamidronate and placeboPatients will receive two infusions simultaneously, at each study visit, one of Pamidronate and another of the placebo. After completing 3 cycles of study treatment, patients will resume their monthly intravenous pamidronate infusions as per current standard of care.
Zoledronic acid and placeboPatients will receive two infusions simultaneously, at each study visit, one of Zoledronic acid and another of the placebo. After completing 3 cycles of study treatment, patients will resume their monthly intravenous pamidronate infusions as per current standard of care.
Start Date: August 2012
Completed Date: January 2016
Phase: Phase 4
Primary Outcome: sCTX values
Secondary Outcome: Palliative response
Study sponsors, principal investigator, and references
Principal Investigator: Mark Clemons, Dr.
Lead Sponsor: Ottawa Hospital Research Institute
Collaborator: Canadian Breast Cancer Foundation