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Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

Primary Purpose

Breast Cancer, Castration-resistant Prostate Cancer

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Bone modifying agent
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Bone modifying agents, BMA, Breast cancer, Castration-resistant prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA
  • Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases
  • Age 18 years or older
  • Able to provide verbal consent

Exclusion Criteria:

  • Definite contraindication for BMA
  • History of, or current evidence of osteonecrosis of the jaw
  • Radiotherapy or surgery to the bone planned within 4 weeks after randomization
  • Current hypercalcemia defined as corrected serum calcium of > 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)

Sites / Locations

  • The Ottawa Hospital Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard BMA frequency

De-escalate BMA to once every 24 weeks

Arm Description

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.

Bone modifying agent once every 24 weeks.

Outcomes

Primary Outcome Measures

Health related quality of life scores
Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting.

Secondary Outcome Measures

Symptomatic Skeletal Event (SSE)
Number of patients with one or more SSEs (defined as: use of radiotherapy to relieve skeletal symtoms, new symptomatic pathological bone fractures [vertebral or non-vertebral], spinal cord compression, tumour-related orthopedic surgical intervention, or hypercalcaemia] during trial period) up to 2 years post-randomization.
Time to development of Symptomatic Skeletal Event
Defined from the date of randomization until the first date of patient experience an SSE. Any patient who does not experience an SSE will be censored on the last follow-up date and the patient can be confirmed as SSE-free (up to 2 years).
Symptomatic Skeletal Event-free survival
SSE-free survival (composite of time to first SSE and time to death)
Skeletal morbidity
Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years.
Quality of life of cancer patients using the EORTC-QLQ-C30
Assess quality of life of cancer patients using the EORTC-QLQ-C30 (cancer patient specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")
Quality of life of cancer patients using the EORTC-QLQ-BM22
Assess quality of life of cancer patients using the EORTC-QLQ-BM22 (patients with bone metastases specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")
BMA-related toxicity rates
BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments
Incremental cost-effectiveness rations
Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained.

Full Information

First Posted
September 1, 2020
Last Updated
May 10, 2023
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04549207
Brief Title
Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer
Official Title
A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer (REaCT-Hold BMA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2020 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose is to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Castration-resistant Prostate Cancer
Keywords
Bone modifying agents, BMA, Breast cancer, Castration-resistant prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard BMA frequency
Arm Type
Active Comparator
Arm Description
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.
Arm Title
De-escalate BMA to once every 24 weeks
Arm Type
Active Comparator
Arm Description
Bone modifying agent once every 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Bone modifying agent
Other Intervention Name(s)
Zoledronate, Denosumab, Pamidronate
Intervention Description
Use of bone modifying agent
Primary Outcome Measure Information:
Title
Health related quality of life scores
Description
Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting.
Time Frame
48 weeks after randomization (one year of treatment)
Secondary Outcome Measure Information:
Title
Symptomatic Skeletal Event (SSE)
Description
Number of patients with one or more SSEs (defined as: use of radiotherapy to relieve skeletal symtoms, new symptomatic pathological bone fractures [vertebral or non-vertebral], spinal cord compression, tumour-related orthopedic surgical intervention, or hypercalcaemia] during trial period) up to 2 years post-randomization.
Time Frame
2 years post-randomization
Title
Time to development of Symptomatic Skeletal Event
Description
Defined from the date of randomization until the first date of patient experience an SSE. Any patient who does not experience an SSE will be censored on the last follow-up date and the patient can be confirmed as SSE-free (up to 2 years).
Time Frame
2 years post-randomization
Title
Symptomatic Skeletal Event-free survival
Description
SSE-free survival (composite of time to first SSE and time to death)
Time Frame
2 years post-randomization
Title
Skeletal morbidity
Description
Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years.
Time Frame
2 years post-randomization
Title
Quality of life of cancer patients using the EORTC-QLQ-C30
Description
Assess quality of life of cancer patients using the EORTC-QLQ-C30 (cancer patient specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")
Time Frame
48 weeks post-randomization
Title
Quality of life of cancer patients using the EORTC-QLQ-BM22
Description
Assess quality of life of cancer patients using the EORTC-QLQ-BM22 (patients with bone metastases specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")
Time Frame
48 weeks post-randomization
Title
BMA-related toxicity rates
Description
BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments
Time Frame
2 years post-randomization
Title
Incremental cost-effectiveness rations
Description
Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained.
Time Frame
2 years post-randomization
Other Pre-specified Outcome Measures:
Title
Frequency of subsequent de-escalation or discontinuation of BMAs
Description
In the continuation arm, frequency of subsequent de-escalation or discontinuation of BMAs
Time Frame
2 years post-randomization
Title
Frequency of restarting standard dosing BMA
Description
In the de-escalation arm, frequency of restarting standard dosing BMA (and the reasons for restarting)
Time Frame
2 years post-randomization
Title
Overall survival
Description
Overall survival during study duration
Time Frame
2 years post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer or breast cancer who are currently receiving BMA Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases Age 18 years or older Able to provide verbal consent Exclusion Criteria: Definite contraindication for BMA History of, or current evidence of osteonecrosis of the jaw Radiotherapy or surgery to the bone planned within 4 weeks after randomization Current hypercalcemia defined as corrected serum calcium of > 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Vandermeer
Phone
613-737-7700
Ext
73039
Email
lvandermeer@toh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marta Sienkiewicz
Phone
613-737-7700
Ext
77212
Email
msienkiewicz@ohri.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terry Ng, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

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