Clinical trial NCT02751710: Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Official title: Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)
Stage IIb Breast Cancer (T3N0)
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Cancer Care Ontario
First posted: 2016-04-26
Enrollment: 369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients upstaged to Stage IV disease
timeFrame: Within 30 days from date of randomization
Secondary outcomes:
measure: Proportion of patients who receive multimodal therapy of curative intent
timeFrame: Within 12 months from date of randomization
measure: Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging
timeFrame: Within 12 months from date of randomization
measure: Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy
timeFrame: Within 12 months from date of randomization
measure: Disease Free Survival
timeFrame: From date of randomization to date of event, assessed up to 5 years
measure: Overall Survival
timeFrame: From date of randomization to date of event, assessed up to 5 years
measure: Incremental economic analysis comparing the costs and outcomes of the treatment arms
timeFrame: Within 5 years from date of randomization
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Juravinski Hospital and Cancer Centre
name: Ian Dayes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Andrea Eisen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Michael's Hospital, CIBC Breast Centre
name: Ralph George, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Ur Metser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group (OCOG)
name: Mark Levine, MD
role: STUDY_DIRECTOR
References: