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

Primary Purpose

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

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Whole-body FDG PET-CT alone

About this trial

This is an interventional diagnostic trial for Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Juravinski Cancer Centre
London Regional Cancer Program
Ottawa Hospital Regional Cancer Centre
Thunder Bay Regional Health Sciences Centre
Sunnybrook Odette Cancer Centre
Princess Margaret Cancer Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Whole-body FDG PET-CT alone

Conventional breast cancer staging

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients who receive multimodal therapy of curative intent

Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging

Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy

Disease Free Survival

Objectively defined local or distance recurrence or death

Overall Survival

Defined by all-cause mortality

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.

Full Information

NCT ID

NCT02751710

First Posted

April 15, 2016

Last Updated

August 9, 2023

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Cancer Care Ontario

1. Study Identification

Unique Protocol Identification Number

NCT02751710

Brief Title

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

Acronym

PET ABC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

December 6, 2016 (Actual)

Primary Completion Date

March 31, 2023 (Actual)

Study Completion Date

March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Cancer Care Ontario

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

369 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole-body FDG PET-CT alone

Arm Type

Experimental

Arm Title

Conventional breast cancer staging

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Whole-body FDG PET-CT alone

Intervention Description

FDG PET-CT imaging

Primary Outcome Measure Information:

Title

Proportion of patients upstaged to Stage IV disease

Description

Proportion of patients upstaged to Stage IV disease as a result of the imaging study, between the groups

Time Frame

Within 30 days from date of randomization

Secondary Outcome Measure Information:

Title

Proportion of patients who receive multimodal therapy of curative intent

Time Frame

Within 12 months from date of randomization

Title

Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging

Time Frame

Within 12 months from date of randomization

Title

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

Title

Disease Free Survival

Description

Objectively defined local or distance recurrence or death

Time Frame

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

Title

Overall Survival

Description

Defined by all-cause mortality

Time Frame

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

Title

Incremental economic analysis comparing the costs and outcomes of the treatment arms

Description

Time Frame

Within 5 years from date of randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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): 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. 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.

Overall Study Officials: