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

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04549207
• Other study ID #: REaCT-Hold BMA
• Status: Recruiting
• Phase: Phase 4
• Start date: October 9, 2020
• Est. completion date: November 2025

Study information

• Verified date: May 2023
• Source: Ottawa Hospital Research Institute
• Contact: Lisa Vandermeer
• Phone: 613-737-7700
• Email: lvandermeer[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bone modifying agent
Use of bone modifying agent

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of subsequent de-escalation or discontinuation of BMAs	In the continuation arm, frequency of subsequent de-escalation or discontinuation of BMAs	2 years post-randomization
Other	Frequency of restarting standard dosing BMA	In the de-escalation arm, frequency of restarting standard dosing BMA (and the reasons for restarting)	2 years post-randomization
Other	Overall survival	Overall survival during study duration	2 years post-randomization
Primary	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.	48 weeks after randomization (one year of treatment)
Secondary	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.	2 years post-randomization
Secondary	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).	2 years post-randomization
Secondary	Symptomatic Skeletal Event-free survival	SSE-free survival (composite of time to first SSE and time to death)	2 years post-randomization
Secondary	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.	2 years post-randomization
Secondary	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")	48 weeks post-randomization
Secondary	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")	48 weeks post-randomization
Secondary	BMA-related toxicity rates	BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments	2 years post-randomization
Secondary	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.	2 years post-randomization