Ignite Creation Date:
2024-05-05 @ 10:36 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01144481
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2010-06-11
Brief Title:
Risk Factors for Skeletal Related Events in Breast Cancer Patients Receiving Bisphosphonates for Bone Metastases
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Prospective Identification of Risk Factors for Skeletal Related Events in Breast Cancer Patients Receiving Bisphosphonates for Bone Metastases
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVISTII
Brief Summary:
Bone is the most common site of distant breast cancer recurrence and 65-75 of women with advanced breast cancer will develop bone metastases during the course of their disease The most pressing problem in management of bony metastases today is the inability to reliably identify patients at high risk for skeletal related events SREs such as bone fractures surgeryradiotherapy for pain or prevention of fractures high calcium levels and spinal cord compression despite the standard use of bone medication bisphosphonates Using the latest innovations both in imaging and blood tests this novel pilot project will develop a risk model for predicting bone metastases which will be able to identify patients who would most benefit from novel treatments such as the multikinase inhibitor Zactima and the Src inhibitor AZD0530 Given that approximately 13 of patients with metastatic breast cancer and bony disease will sustain an SRE despite use of a bisphosphonate there is an urgent unmet need in this large population to introduce effective bone protective agents
Detailed Description:
Bone is the most common site of distant breast cancer recurrence and 65-75 of women with advanced breast cancer will develop bone metastases during the course of their disease Bone metastases can significantly adversely impact on quality of life by causing pain and skeletal related events SREs such as pathological fractures surgeryradiotherapy for painprevention of fractures hypercalcemia and spinal cord compression These complications of bone metastases may necessitate multiple medical surgical and radiation interventions Indeed prior to the widespread use of bisphosphonates over two thirds 23 of women with bone metastases developed at least one SRE Despite prolonged bisphosphonate use many patients will continue to have progression of their bone metastases and develop SREs The most pressing problem in management of bony metastases today is the inability to reliably identify patients at high risk for SREs despite standard bisphosphonate use
Using a prospective observational trial design we will develop a prognostic model with baseline serum C-telopeptide sCTx as the predictor variable and SREs as the outcome variable 60 breast cancer patients with metastases to any site will be approached for participation in this prospective single centered study Baseline characteristics and potential risk factors will be recorded upon study enrollment including clinical factors prior fragility fracture use of corticosteroids age bone mineral density performance status measures of quality of life and pain Novel markers such as sCTx and bone specific alkaline phosphatase bALP will also be assessed The WHO fracture risk assessment tool httpwwwshefacuk will be used to estimate baseline fracture risk according to osteoporosis guidelines and a calcium intake diet history will be taken In addition assessment of vertebral fractures will take place using two novel techniques bone densitometric vertebral fracture assessment VFA and high resolution quantitative CT HR-pQCT Bone mineral density along with VFA will be performed at baseline and at one year of treatment
Patients will be assessed every twelve weeks for twenty-four months with regards to symptoms related to SREs ECOG status pain using the BPI a 7-point scale of analgesic use and quality of life using the FACT-BP and FACT-BTSQ In addition to being measured at baseline sCTx and bALP will be measured every twelve weeks for twenty-four months Calcium and 25-hydroxy vitamin D will be measured annually as part of regular clinical practice and a CT scan of the thorax and abdomen as well as a bone scan will be preformed at least once yearly as part of regular clinical practice for patients with metastatic breast cancer
Using the latest innovations both in imaging and medical biomarkers this novel pilot project will develop a prospective risk model for predicting bone metastases which will be able to identify patients who would most benefit from novel treatments such as the multikinase inhibitor Zactima and the Src inhibitor AZD0530
Using a prospective observational trial design we will develop a prognostic model with baseline serum C-telopeptide sCTx as the predictor variable and SREs as the outcome variable 60 breast cancer patients with metastases to any site will be approached for participation in this prospective single centered study Baseline characteristics and potential risk factors will be recorded upon study enrollment including clinical factors prior fragility fracture use of corticosteroids age bone mineral density performance status measures of quality of life and pain Novel markers such as sCTx and bone specific alkaline phosphatase bALP will also be assessed The WHO fracture risk assessment tool httpwwwshefacuk will be used to estimate baseline fracture risk according to osteoporosis guidelines and a calcium intake diet history will be taken In addition assessment of vertebral fractures will take place using two novel techniques bone densitometric vertebral fracture assessment VFA and high resolution quantitative CT HR-pQCT Bone mineral density along with VFA will be performed at baseline and at one year of treatment
Patients will be assessed every twelve weeks for twenty-four months with regards to symptoms related to SREs ECOG status pain using the BPI a 7-point scale of analgesic use and quality of life using the FACT-BP and FACT-BTSQ In addition to being measured at baseline sCTx and bALP will be measured every twelve weeks for twenty-four months Calcium and 25-hydroxy vitamin D will be measured annually as part of regular clinical practice and a CT scan of the thorax and abdomen as well as a bone scan will be preformed at least once yearly as part of regular clinical practice for patients with metastatic breast cancer
Using the latest innovations both in imaging and medical biomarkers this novel pilot project will develop a prospective risk model for predicting bone metastases which will be able to identify patients who would most benefit from novel treatments such as the multikinase inhibitor Zactima and the Src inhibitor AZD0530
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None