Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549207
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer Castration-resistant Prostate Cancer Drug: Bone modifying agent Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Standard BMA frequency
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.
Drug: Bone modifying agent
Use of bone modifying agent
Other Names:
  • Zoledronate
  • Denosumab
  • Pamidronate

Active Comparator: De-escalate BMA to once every 24 weeks
Bone modifying agent once every 24 weeks.
Drug: Bone modifying agent
Use of bone modifying agent
Other Names:
  • Zoledronate
  • Denosumab
  • Pamidronate




Primary Outcome Measures :
  1. Health related quality of life scores [ Time Frame: 48 weeks after randomization (one year of treatment) ]
    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 :
  1. Symptomatic Skeletal Event (SSE) [ Time Frame: 2 years post-randomization ]
    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.

  2. Time to development of Symptomatic Skeletal Event [ Time Frame: 2 years post-randomization ]
    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).

  3. Symptomatic Skeletal Event-free survival [ Time Frame: 2 years post-randomization ]
    SSE-free survival (composite of time to first SSE and time to death)

  4. Skeletal morbidity [ Time Frame: 2 years post-randomization ]
    Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years.

  5. Quality of life of cancer patients using the EORTC-QLQ-C30 [ Time Frame: 48 weeks post-randomization ]
    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")

  6. Quality of life of cancer patients using the EORTC-QLQ-BM22 [ Time Frame: 48 weeks post-randomization ]
    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")

  7. BMA-related toxicity rates [ Time Frame: 2 years post-randomization ]
    BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments

  8. Incremental cost-effectiveness rations [ Time Frame: 2 years post-randomization ]
    Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained.


Other Outcome Measures:
  1. Frequency of subsequent de-escalation or discontinuation of BMAs [ Time Frame: 2 years post-randomization ]
    In the continuation arm, frequency of subsequent de-escalation or discontinuation of BMAs

  2. Frequency of restarting standard dosing BMA [ Time Frame: 2 years post-randomization ]
    In the de-escalation arm, frequency of restarting standard dosing BMA (and the reasons for restarting)

  3. Overall survival [ Time Frame: 2 years post-randomization ]
    Overall survival during study duration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT04549207


Contacts
Layout table for location contacts
Contact: Lisa Vandermeer 613-737-7700 ext 73039 lvandermeer@toh.ca
Contact: Marta Sienkiewicz 613-737-7700 ext 77212 msienkiewicz@ohri.ca

Locations
Layout table for location information
Canada, Ontario
The Ottawa Hospital Cancer Centre Recruiting
Ottawa, Ontario, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Terry Ng, MD Ottawa Hospital Research Institute
Layout table for additonal information
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04549207    
Other Study ID Numbers: REaCT-Hold BMA
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Bone modifying agents
BMA
Breast cancer
Castration-resistant prostate cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Denosumab
Zoledronic Acid
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs