Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)PET ABCNCT02751710
Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
A study testing Whole-body FDG PET-CT alone in people with Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) and Stage IIb Breast Cancer (T3N0), run by Ontario Clinical Oncology Group (OCOG) at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), Stage IIb Breast Cancer (T3N0)
- What is being tested?
- Whole-body FDG PET-CT alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 6 sitesCanada
- Study dates
- 6 Dec 2016to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Regional Cancer Program
London, Ontario, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
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.
- Being tested
- Whole-body FDG PET-CT alone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body FDG PET-CT aloneOther
FDG PET-CT imaging
| Study group | Role | What they receive |
|---|---|---|
| Whole-body FDG PET-CT alone | Experimental | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 days from date of randomization
Secondary outcomes (6)
Proportion of patients who receive multimodal therapy of curative intent
Measured: Within 12 months from date of randomization
Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging
Measured: 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
Measured: Within 12 months from date of randomization
Disease Free Survival
Objectively defined local or distance recurrence or death
Measured: From date of randomization to date of event, assessed up to 5 years
Overall Survival
Defined by all-cause mortality
Measured: From date of randomization to date of event, assessed up to 5 years
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.
Measured: Within 5 years from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study start6 Dec 2016
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Care Ontario
- Responsible party
- Sponsor
- Investigators
- Ian Dayes, MD, Principal investigator, Juravinski Hospital and Cancer CentreAndrea Eisen, MD, Principal investigator, Sunnybrook Health Sciences CentreRalph George, MD, Principal investigator, St. Michael's Hospital, CIBC Breast CentreUr Metser, MD, Principal investigator, Princess Margaret Hospital, CanadaMark Levine, MD, Study director, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02751710
- Sponsor's protocol ID
- OCOG-2016-PETABC
- Acronym
- PET ABC
- Status last verified
- Jan 2024
- First submitted
- 15 Apr 2016
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Metser U, Dayes IS, Parpia S, Eisen AF, Hodgson N, Cil TD, George R, Blanchette P, Arnaout A, Chan A, Levine MN. Prospective study on 18F-FDG PET-CT for staging locally advanced invasive lobular breast carcinoma. Br J Cancer. 2026 May;134(10):1387-1392. doi: 10.1038/s41416-026-03362-9. Epub 2026 Mar 2.
PubMed 41772273Metser 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.
PubMed 40762843Dayes 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.
PubMed 37235845
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
- ClinicalTrials.gov ID
- NCT02751710
- Acronym / sponsor ID
- PET ABC / OCOG-2016-PETABC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Cancer Care Ontario
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned.
- Based on clinical information (physical exam, imaging):
- Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent.
Key exclusion criteria (12 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body FDG PET-CT aloneFDG PET-CT imaging | Other | Whole-body FDG PET-CT alone |
Primary outcome
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
6 secondary outcomes
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
Overall Survival
Time frame: From date of randomization to date of event, assessed up to 5 years
Incremental economic analysis comparing the costs and outcomes of the treatment arms
Time frame: Within 5 years from date of randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Derived from this study: PubMed 41772273Metser U, Dayes IS, Parpia S, Eisen AF, Hodgson N, Cil TD, George R, Blanchette P, Arnaout A, Chan A, Levine MN. Prospective study on 18F-FDG PET-CT for staging locally advanced invasive lobular breast carcinoma. Br J Cancer. 2026 May;134(10):1387-1392. doi: 10.1038/s41416-026-03362-9. Epub 2026 Mar 2.
- Derived from this study: PubMed 40762843Metser 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.
- Derived from this study: PubMed 37235845Dayes 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Dayes, MD principal investigator
Juravinski Hospital and Cancer Centre
Andrea Eisen, MD principal investigator
Sunnybrook Health Sciences Centre
Ralph George, MD principal investigator
St. Michael's Hospital, CIBC Breast Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body FDG PET-CT alone in people with Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) and Stage IIb Breast Cancer (T3N0), run by Ontario Clinical Oncology Group (OCOG) at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients upstaged to Stage IV disease (time frame: Within 30 days from date of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02751710, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.