NCT06328465 fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
| NCT ID | NCT06328465 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Invasive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2019-11-22 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 145 participants in total. It began in 2019-11-22 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Monica Iorfida, MD
PRINCIPAL INVESTIGATOR
European Institute of Oncology
Frequently Asked Questions
Who can join the NCT06328465 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Invasive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06328465 currently recruiting?
Yes, NCT06328465 is actively recruiting participants. Contact the research team at monica.iorfida@ieo.it for enrollment information.
Where is the NCT06328465 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06328465 clinical trial?
NCT06328465 is sponsored by European Institute of Oncology. The principal investigator is Monica Iorfida, MD at European Institute of Oncology. The trial plans to enroll 145 participants.
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