The ODYSSEY TRIAL Phase IV Trial Evaluating the Palliative Benefit of Pamidronate or Zoledronic Acid in Breast Cancer

NCT01907880 | Completed Phase 4 DMC

• 1 other identifier: 2011349-01H
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast; bone; pain

Outcome Measures

Primary Outcomes (1)

• sCTX values

  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.

  baseline, 1 week post treatment, week 4, week 8, week 12

Secondary Outcomes (1)

• Palliative response

  baseline, week 1, week 4, week 8, week 12.

Other Outcomes (1)

• predictor of pain benefit

  week 1 and week 12

Study Arms (2)

Pamidronate and placebo

ACTIVE COMPARATOR

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; Drug: placebo

Zoledronic acid and placebo

ACTIVE COMPARATOR

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; Drug: placebo

Interventions

Pamidronate DRUG

90mg IV once every 4 weeks for 3 cycles

Also known as: ADP Sodium, Aredia®

Pamidronate and placebo

Zoledronic acid DRUG

4mg IV every 4 weeks for 3 cycles

Also known as: Reclast, Zometa, Aclasta

Zoledronic acid and placebo

placebo DRUG

Pamidronate and placebo; Zoledronic acid and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain

Interventions

Pamidronate; Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Clemons, Dr.

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 25, 2013
• Study Start: August 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 7, 2017

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)