Breast Cancer, Castration-resistant Prostate Cancer
Conditions
Keywords
Bone modifying agents, BMA, Breast cancer, Castration-resistant prostate cancer
Brief summary
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
Interventions
DRUGBone modifying agent
Use of bone modifying agent
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| Symptomatic Skeletal Event-free survival | 2 years post-randomization | SSE-free survival (composite of time to first SSE and time to death) |
| 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. |
| 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") |
| 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") |
| 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 |
| 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORTerry Ng, MD
Ottawa Hospital Research Institute
Outcome results
None listed