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

O

Ontario Clinical Oncology Group (OCOG)

Status

Completed

Conditions

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

Treatments

Other: Whole-body FDG PET-CT alone

Study type

Interventional

Funder types

Other

Identifiers

NCT02751710
OCOG-2016-PETABC

Details and patient eligibility

About

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.

Enrollment

369 patients

Sex

All

Ages

18+ years old

Volunteers

No 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):

  • 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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

369 participants in 2 patient groups

Whole-body FDG PET-CT alone
Experimental group
Treatment:
Other: Whole-body FDG PET-CT alone
Conventional breast cancer staging
No Intervention group
Description:
Conventional breast cancer staging consisting of a bone scan and CT imaging with contrast of the chest / abdomen & pelvis

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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