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Bone Modifying Agent

Bone Modifying Agents for Breast and Prostate Cancer

Phase 4

Waitlist Available

Led By Terry Ng, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases

Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA

Must not have

History of or current evidence of osteonecrosis of the jaw

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 weeks after randomization (one year of treatment)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will compare continuing or further reducing bone metastases treatment after two years in patients with breast or prostate cancer.

Who is the study for?

This trial is for adults over 18 with bone metastases from breast or castration-resistant prostate cancer, who have been on bone modifying agents (BMAs) for at least two years. It's not suitable for those with high calcium levels, contraindications to BMA, jawbone issues, or upcoming bone surgery/radiotherapy within a month.

What is being tested?

The study tests the effectiveness and safety of either continuing or reducing the dosage of BMAs after two years of treatment in patients with certain types of cancer that has spread to bones. Participants will be randomly assigned to one of these two approaches.

What are the potential side effects?

While specific side effects are not listed here, BMAs can generally cause issues like flu-like symptoms, low calcium levels in blood, digestive problems, and rarely conditions such as osteonecrosis of the jaw.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on bone-modifying agents for over 2 years for bone metastases.

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I have bone metastases from prostate or breast cancer and am receiving bone-modifying agents.

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I have bone metastases from prostate or breast cancer and am on bone-modifying agents.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or had bone disease in my jaw.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 weeks after randomization (one year of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 weeks after randomization (one year of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks after randomization (one year of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Health related quality of life scores

Secondary study objectives

BMA-related toxicity rates

Incremental cost-effectiveness rations

Quality of life of cancer patients using the EORTC-QLQ-BM22

+5 more

Other study objectives

Frequency of restarting standard dosing BMA

Frequency of subsequent de-escalation or discontinuation of BMAs

Overall survival

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard BMA frequencyActive Control1 Intervention

Continue standard BMA frequency (every 4 or 12 weeks) as administered previously. If a change in BMA frequency (every 4 weeks to every 12 weeks OR every 12 weeks to every 4 weeks) was prescribed by the physician, this would still be considered on protocol treatment.

Group II: De-escalate BMA to once every 24 weeksActive Control1 Intervention

Bone modifying agent once every 24 weeks.

0 / 5Eligibility criteria met