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

NCT ID: NCT02751710

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-06
• Study Completion Date: 2023-03-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Whole-body FDG PET-CT alone

Group Type: EXPERIMENTAL

Whole-body FDG PET-CT alone

Intervention Type: OTHER

FDG PET-CT imaging

Conventional breast cancer staging

Conventional breast cancer staging consisting of a bone scan and CT imaging with contrast of the chest / abdomen \& pelvis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Whole-body FDG PET-CT alone

FDG PET-CT imaging

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Care Ontario

OTHER

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Dayes, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Hospital and Cancer Centre

Andrea Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Ralph George, MD

Role: PRINCIPAL_INVESTIGATOR

St. Michael's Hospital, CIBC Breast Centre

Ur Metser, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Mark Levine, MD

Role: STUDY_DIRECTOR

Ontario Clinical Oncology Group (OCOG)

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

Metser U, Ali Mirshahvalad S, Dayes IS, Parpia S, Levine MN. 18F-FDG PET/CT of Oligometastatic Disease in Locally Advanced Breast Cancer: PETABC Trial Post Hoc Analysis. Radiology. 2025 Aug;316(2):e243788. doi: 10.1148/radiol.243788.

Reference Type: DERIVED

PMID: 40762843 (View on PubMed)

Dayes IS, Metser U, Hodgson N, Parpia S, Eisen AF, George R, Blanchette P, Cil TD, Arnaout A, Chan A, Levine MN. Impact of 18F-Labeled Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography Versus Conventional Staging in Patients With Locally Advanced Breast Cancer. J Clin Oncol. 2023 Aug 10;41(23):3909-3916. doi: 10.1200/JCO.23.00249. Epub 2023 May 26.

Reference Type: DERIVED

PMID: 37235845 (View on PubMed)

Other Identifiers

OCOG-2016-PETABC

Identifier Type: -

Identifier Source: org_study_id