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NCT Number: NCT02751710

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

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.

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Key information

Conditions

Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Stage IIb Breast Cancer (T3N0)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juravinski Cancer Centre, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-body FDG PET-CT alone

Other

FDG PET-CT imaging

Primary outcomes

  1. 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

Secondary outcomes

  1. Proportion of patients who receive multimodal therapy of curative intent

    Time frame: Within 12 months from date of randomization

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

    Time frame: Within 12 months from date of randomization

  3. 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

  4. Disease Free Survival

    Time frame: From date of randomization to date of event, assessed up to 5 years

    Objectively defined local or distance recurrence or death

  5. Overall Survival

    Time frame: From date of randomization to date of event, assessed up to 5 years

    Defined by all-cause mortality

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

    Time frame: Within 5 years from date of randomization

    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.

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Cancer Care Ontario

Registry information

Acronym: PET ABC

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2016
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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