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)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4); Stage IIb Breast Cancer (T3N0)	Other: Whole-body FDG PET-CT alone	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 369 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
• Actual Study Start Date: December 6, 2016
• Actual Primary Completion Date: March 31, 2023
• Actual Study Completion Date: March 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Proportion of patients who receive multimodal therapy of curative intent [ Time Frame: Within 12 months from date of randomization ]
2. Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging [ Time Frame: Within 12 months from date of randomization ]
3. 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 ]
4. 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
5. Overall Survival [ Time Frame: From date of randomization to date of event, assessed up to 5 years ]
   Defined by all-cause mortality
6. 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.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Canada, Ontario

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

London Regional Cancer Program

London, Ontario, Canada, N6A 4L6

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada, K1H 8L6

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada, P7B 6V4

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

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)

More Information

• Responsible Party: Ontario Clinical Oncology Group (OCOG)
• ClinicalTrials.gov Identifier: NCT02751710
• Other Study ID Numbers: OCOG-2016-PETABC
• First Posted: April 26, 2016
• Last Update Posted: January 19, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases