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

Phase 4

Active, not recruiting

• Conditions: Breast Cancer; Castration-resistant Prostate Cancer
• Interventions: Drug: Bone modifying agent

• Registration Number: NCT04549207
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-16
• Study Start: 2020-10-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard BMA frequency	Bone modifying agent	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.
De-escalate BMA to once every 24 weeks	Bone modifying agent	Bone modifying agent once every 24 weeks.

Primary Outcome Measures

Name	Time	Method
Health related quality of life scores	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

Name	Time	Method
Time to development of Symptomatic Skeletal Event	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).
Quality of life of cancer patients using the EORTC-QLQ-C30	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")
Symptomatic Skeletal Event-free survival	2 years post-randomization	SSE-free survival (composite of time to first SSE and time to death)
Incremental cost-effectiveness rations	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.
Symptomatic Skeletal Event (SSE)	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.
Quality of life of cancer patients using the EORTC-QLQ-BM22	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")
Skeletal morbidity	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.
BMA-related toxicity rates	2 years post-randomization	BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments

Trial Locations

Locations (1)

The Ottawa Hospital Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada