Stage IIb Breast Cancer (T3N0), Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)
Conditions
Brief summary
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.
Interventions
OTHERWhole-body FDG PET-CT alone
FDG PET-CT imaging
Sponsors
Cancer Care Ontario
Ontario Clinical Oncology Group (OCOG)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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): 1. Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients upstaged to Stage IV disease | Within 30 days from date of randomization | Proportion of patients upstaged to Stage IV disease as a result of the imaging study, between the groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Proportion of patients who receive multimodal therapy of curative intent | Within 12 months from date of randomization | — |
| Overall Survival | From date of randomization to date of event, assessed up to 5 years | Defined by all-cause mortality |
| Incremental economic analysis comparing the costs and outcomes of the treatment arms | Within 5 years from date of randomization | 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. |
| Disease Free Survival | From date of randomization to date of event, assessed up to 5 years | Objectively defined local or distance recurrence or death |
Countries
Canada
Outcome results
None listed