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 4Active Not RecruitingNCT04549207

Ottawa Hospital Research Institute240 enrolled

Overview

The investigators propose 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

240

Conditions

Breast Cancer Castration-resistant Prostate Cancer

Interventions

Bone modifying agent

Use of bone modifying agent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (5)

William Osler Health System

Brampton, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 48 weeks after randomization (one year of treatment)

Secondary Outcomes

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 frame: 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).

Time frame: 2 years post-randomization

Symptomatic Skeletal Event-free survival

SSE-free survival (composite of time to first SSE and time to death)

Time frame: 2 years post-randomization

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.

Time frame: 2 years post-randomization

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")

Time frame: 48 weeks post-randomization

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")

Time frame: 48 weeks post-randomization

BMA-related toxicity rates

BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments

Time frame: 2 years post-randomization

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.

Time frame: 2 years post-randomization

Data from ClinicalTrials.gov

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