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

NCT02751710 | Completed DMC

• 1 other identifier: OCOG-2016-PETABC
• Study Type: interventional
• Target: 369
• Locations: 1 country
• Sites: 6

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  From date of randomization to date of event, assessed up to 5 years

• Overall Survival

  From date of randomization to date of event, assessed up to 5 years

Study Arms (2)

Whole-body FDG PET-CT alone

EXPERIMENTAL

Other: Whole-body FDG PET-CT alone

Conventional breast cancer staging

NO INTERVENTION

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

Interventions

Whole-body FDG PET-CT alone OTHER

FDG PET-CT imaging

Whole-body FDG PET-CT alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned.
• Based on clinical information (physical exam, imaging):
• Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or
• Stage IIb breast cancer (T3N0), Note: T2N1 is not eligible
• Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Cancer Care Ontario: collaborator

Study Sites (6)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• 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.

  PMID: 40762843 DERIVED

• 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.

  PMID: 37235845 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Mark Levine, MD

  Ontario Clinical Oncology Group (OCOG)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 26, 2016
• Study Start: December 6, 2016
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)