This trial is being conducted to determine the impact of whole body FDG PET-CT vs. conventional staging in the management of patients presenting with clinical Stage III breast cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen \& pelvis and a bone scan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
369
FDG PET-CT imaging
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Proportion of patients upstaged to Stage IV disease
Proportion of patients upstaged to Stage IV disease as a result of the imaging study, between the groups
Time frame: Within 30 days from date of randomization
Proportion of patients who receive multimodal therapy of curative intent
Time frame: Within 12 months from date of randomization
Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging
Time frame: Within 12 months from date of randomization
Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy
Time frame: Within 12 months from date of randomization
Disease Free Survival
Objectively defined local or distance recurrence or death
Time frame: From date of randomization to date of event, assessed up to 5 years
Overall Survival
Defined by all-cause mortality
Time frame: From date of randomization to date of event, assessed up to 5 years
Incremental economic analysis comparing the costs and outcomes of the treatment arms
Utility values will be collected using the EQ-5D Health Utility Questionnaire and converted to quality adjusted life years (QALYs) by considering Overall Survival. Direct medical resources (i.e. tests, complications, hospitalizations, clinic visits, emergency dept., etc.) will be obtained. Costs ($CAN2016) for each resource identified and utilized will be determined. Finally, an incremental cost-utility analysis will be calculated comparing the 2 randomized arms to generate an incremental cost per QALY outcome.
Time frame: Within 5 years from date of randomization
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