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The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer (ER11-03)

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ClinicalTrials.gov Identifier: NCT01907880
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : July 7, 2017
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Pamidronate Drug: Zoledronic acid Drug: placebo Phase 4

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 high-risk of subsequent SREs will be screened for entry into this study. High-risk will be defined as fulfilling one or more of the following criteria: elevated sCTX (>400ng/L) and/or bone pain and/or a prior SRE and/or progression of bone disease (by imaging) despite at least 3 months of pamidronate therapy. Patients who meet the eligibility criteria, will be randomized to receive 3 cycles of intravenous zoledronic acid (4mg intravenously over 15 minutes) or to continue their standard dose of pamidronate. Both treatments will be given at 4 week intervals. Patients will be stratified according to whether or not they have had a SRE prior to study entry, progressive bone disease or bone pain. In order for the study to be double-blind, patients will receive two infusions simultaneously, at each study visit, one of the active drug 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase IV Trial Evaluating the Palliative Benefit of Either Continuing Pamidronate or Switching to Second-line Zoledronic Acid in Breast Cancer Patients With High-risk Bone Metastases.
Study Start Date : August 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Pamidronate and placebo
Patients 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.
Drug: Pamidronate
90mg IV once every 4 weeks for 3 cycles
Other Names:
  • ADP Sodium
  • Aredia®

Drug: placebo
Active Comparator: Zoledronic acid and placebo
Patients 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.
Drug: Zoledronic acid
4mg IV every 4 weeks for 3 cycles
Other Names:
  • Reclast
  • Zometa
  • Aclasta

Drug: placebo



Primary Outcome Measures :
  1. sCTX values [ Time Frame: baseline, 1 week post treatment, week 4, week 8, week 12 ]
    To compare the proportion of high-risk metastatic breast cancer patients with bone metastases that will achieve a decrease in sCTX (surrogate for decrease risk of SREs) in the zoledronic and pamidronate treatment arms.


Secondary Outcome Measures :
  1. Palliative response [ Time Frame: baseline, week 1, week 4, week 8, week 12. ]
    To determine the proportion of high-risk metastatic breast cancer patients that will achieve a significant improvement in palliative response (18) (defined as a two unit drop in their worst pain score, based on a brief pain inventory questionnaire for two consecutive measurements at least one month apart) in the zoledronic and pamidronate treatment arms.


Other Outcome Measures:
  1. predictor of pain benefit [ Time Frame: week 1 and week 12 ]
    To assess whether a drop in sCTX one week post infusion of zoledronic acid is a predictor of pain benefit at week 12. We will test the strength of the association in sCTX drop (any drop from baseline level) at week 1 and palliative response when measured at week 12, using the validated BPI and FACT-BP questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907880


Locations
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Canada, Ontario
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Investigators
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Principal Investigator: Mark Clemons, Dr. The Ottawa Hospital

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01907880     History of Changes
Other Study ID Numbers: 2011349-01H
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: results will be published.
Keywords provided by Ottawa Hospital Research Institute:
breast
bone
pain
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs