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Prospective Identification of Risk Factors for Skeletal Related Events in Breast Cancer Patients Receiving Bisphosphonates for Bone Metastases


N/A
N/A
N/A
Open (Enrolling)
Female
Bone Metastases, Breast Cancer

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Trial Information

Prospective Identification of Risk Factors for Skeletal Related Events in Breast Cancer Patients Receiving Bisphosphonates for Bone Metastases


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, surgery/radiotherapy for
pain/prevention 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 (2/3)
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
(http://www.shef.ac.uk) 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.


Inclusion Criteria:



- patients with metastatic breast cancer treated at Princess Margaret Hospital

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Skeletal related event

Outcome Description:

Primary outcome is any SRE such as pathological fractures, surgery/radiotherapy for pain/prevention of fractures, hypercalcemia, and spinal cord compression.

Outcome Time Frame:

0 to 24 months

Safety Issue:

No

Principal Investigator

Angela MW Cheung, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Health Canada

Study ID:

PROVISTII

NCT ID:

NCT01144481

Start Date:

February 2009

Completion Date:

January 2013

Related Keywords:

  • Bone Metastases
  • Breast Cancer
  • bone metastasis
  • breast cancer
  • skeletal related event
  • HR-pQCT
  • VFA
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

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