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fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases

ConditionsInvasive Breast CancerHER2-positive Breast CancerTriple Negative Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEuropean Institute of Oncology

About this trial

The aim of this study is to understand whether DWB-MRI (Diffusion Whole Body-Magnetic Resonance Imaging) is useful for early detection of locoregional or distant recurrence and whether early diagnosis influences the prognosis in high-risk populations thanks to the possibility of being able to use a more effective treatment. The primary objective is to evaluate 5-year overall survival (OS) in patients with Human Epidermal Growth Factor Receptor 2 positive (HER2+) or high-risk Triple Negative (TN) undergoing surveillance with DWB-MRI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pre or post-menopausal patient with histologically confirmed invasive breast cancer stage II - III HER2 + or TN operated breast carcinoma or patients underwent neoadjuvant treatment (included cT4d) with residual disease at definitive surgery

No evidence of distant metastases at baseline perioperative radiological staging (DWB-MRI, total body Computed Tomography (CT) or Positron Emission Tomography (PET/CT) must be performed +/- 1 month from surgery)

No relevant comorbidities

Eastern Cooperative Oncology Group (ECOG) performance status 0

Disqualifiers

Absolute contraindications that exclude the execution of the MRI investigation, regardless of the clinical indication

Relative contraindications that include situations in which the innocuousness of the examination is not documented with certainty that therefore do not recommend the execution, except for serious indications related to the patient's clinical need

Older age (>75 years)

Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix

Trial design

Design model

Single group

Treatments tested in this trial

  • Diffusion whole body MRI

    Diagnostic test

    Diffusion whole body MRI protocol, consisting of sagittal T1-weighted and T2-weighted sequences on the whole spine, axial T1 weighted, T2-weighted and diffusion-weighted images from head to mid-thigh, performed on a 1.5 T scanner.

Treatment groups

145 Participants
are divided into 1 treatment group
Group A: DWB-MRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

5-year overall survival

Number of alive patients at 5 years (considering deaths from any cause)

Time frame
5 years

Secondary outcomes

1

Overall survival of patients underwent local treatment

Number of patients undergoing local treatment (surgery or other localized technique) who are alive at 5 years (considering deaths from any cause)

Time frame
5 years
2

Breast cancer specific survival

Number of alive patients at 5 years (considering only deaths related to breast cancer)

Time frame
5 years
3

Safety of local treatment

Number of serious adverse event related to local treatment received

Time frame
48 months
4

Anxiety assessment

Collection of Hamilton Anxiety Rating Scale questionnaire (minimum value: 0, maximum value: 4 - higher scores mean a worse outcome)

Time frame
48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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