Triple Negative Breast Cancer Clinical Trial
— fREEDOMOfficial title:
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
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.
Status | Recruiting |
Enrollment | 145 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 - Geographically accessible for follow up - Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - 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 - Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements |
Country | Name | City | State |
---|---|---|---|
Italy | European Institute of Oncology | Milan |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5-year overall survival | Number of alive patients at 5 years (considering deaths from any cause) | 5 years | |
Secondary | 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) | 5 years | |
Secondary | Breast cancer specific survival | Number of alive patients at 5 years (considering only deaths related to breast cancer) | 5 years | |
Secondary | Safety of local treatment | Number of serious adverse event related to local treatment received | 48 months | |
Secondary | Anxiety assessment | Collection of Hamilton Anxiety Rating Scale questionnaire (minimum value: 0, maximum value: 4 - higher scores mean a worse outcome) | 48 months | |
Secondary | Health state assessment | Collection of 12-Item Short Form Survey (SF-12) questionnaire (minimum value: 0, maximum value: 6 - higher scores mean a better outcome) | 48 months | |
Secondary | Ability to Cope With Trauma assessment | Collection of Perceived Ability to Cope With Trauma (PACT) questionnaire (minimum value: 0, maximum value: 7 - higher scores mean a better outcome) | 48 months | |
Secondary | Personality assessment | Collection of Big Five Personality Inventory (BFI-10) questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a greater agreement with the statement) | 48 months | |
Secondary | Acceptability and perception of DWB-MRI | Collection of Acceptance Questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a worse outcome) | 48 months |
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