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

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 Overview

• Status: Completed
• Conditions: Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4); Stage IIb Breast Cancer (T3N0)
• Intervention / Treatment: Other: Whole-body FDG PET-CT alone

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Regional Cancer Centre
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Thunder Bay Regional Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborators: Cancer Care Ontario
• Investigators: Principal Investigator: Ur Metser, MD, Princess Margaret Hospital, Canada; Principal Investigator: Andrea Eisen, MD, Sunnybrook Health Sciences Centre; Principal Investigator: Ian Dayes, MD, Juravinski Hospital and Cancer Centre; Principal Investigator: Ralph George, MD, St. Michael's Hospital, CIBC Breast Centre; Study Director: Mark Levine, MD, Ontario Clinical Oncology Group (OCOG)

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2016
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimated): April 26, 2016

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: OCOG-2016-PETABC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO