Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

Conditions
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Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), Stage IIb Breast Cancer (T3N0)

Intervention / Treatment
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* Other: Whole-body FDG PET-CT alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned. Based on clinical information (physical exam, imaging): Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or Stage IIb breast cancer (T3N0), Note: T2N1 is not eligible Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent. Exclusion Criteria: Age < 18 years, ECOG performance status > and = 3, Prior systemic therapy (e.g. neo-adjuvant chemotherapy or hormonal therapy) for current breast cancer, Previous staging investigations for current breast cancer, Breast cancer with primary histological subtypes other than ductal or lobular (Note: Patients with mixed disease will be eligible for randomization), Clinical suspicion of metastatic disease, Relative contraindications to PET (e.g. uncontrolled diabetes (i.e. inability to decrease serum glucose below 10.2 mmol/L), claustrophobia, inability to be still for 30 minutes), Inability to lie supine for imaging with PET-CT, Inability to undergo CT because of known allergy to contrast, History of another invasive malignancy within the previous two years (exception of non melanoma skin cancer) or a synchronous primary cancer, including a synchronous contralateral breast cancer (Note: Patients found to have a contralateral breast cancer on study imaging following randomization will remain in the study), Known pregnancy or lactating female, Inability to complete the study or required follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole-body FDG PET-CT alone<br> | Other: Whole-body FDG PET-CT alone<br>* FDG PET-CT imaging<br>|
| No Intervention: Conventional breast cancer staging<br>Conventional breast cancer staging consisting of a bone scan and CT imaging with contrast of the chest / abdomen & pelvis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 30 days from date of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who receive multimodal therapy of curative intent |  | Within 12 months from date of randomization | 
| Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging |  | 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 |  | Within 12 months from date of randomization | 
| Disease Free Survival | Objectively defined local or distance recurrence or death | From date of randomization to date of event, assessed up to 5 years | 
| Overall Survival | Defined by all-cause mortality | 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. | Within 5 years from date of randomization |