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

• ClinicalTrials.gov Identifier: NCT02751710
• Recruitment Status: Completed
• First Posted: April 26, 2016
• Last Update Posted: January 19, 2024
• Sponsor: Ontario Clinical Oncology Group (OCOG)
• Collaborator: Cancer Care Ontario
• Information provided by (Responsible Party): Ontario Clinical Oncology Group (OCOG)

Tracking Information

• First Submitted Date: April 15, 2016
• First Posted Date: April 26, 2016
• Last Update Posted Date: January 19, 2024
• Actual Study Start Date: December 6, 2016
• Actual Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 21, 2016)

Proportion of patients upstaged to Stage IV disease [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 21, 2016)

• 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 [ Time Frame: From date of randomization to date of event, assessed up to 5 years ]
  Objectively defined local or distance recurrence or death
• Overall Survival [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

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

Intervention

Other: Whole-body FDG PET-CT alone

FDG PET-CT imaging

Study Arms

• Experimental: Whole-body FDG PET-CT alone
  Intervention: Other: Whole-body FDG PET-CT alone
• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 19, 2022): 369
• Original Estimated Enrollment (submitted: April 21, 2016): 370
• Actual Study Completion Date: March 31, 2023
• Actual Primary Completion Date: March 31, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02751710
• Other Study ID Numbers: OCOG-2016-PETABC
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ontario Clinical Oncology Group (OCOG)
• Original Responsible Party: Same as current
• Current Study Sponsor: Ontario Clinical Oncology Group (OCOG)
• Original Study Sponsor: Same as current
• Collaborators: Cancer Care Ontario

Investigators

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

• PRS Account: Ontario Clinical Oncology Group (OCOG)
• Verification Date: January 2024