NCT06328465Recruiting
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 145 (estimated)
- First submitted
- 13 Mar 2024
- Start date
- 22 Nov 2019
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- European Institute of Oncology
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06328465
What you commit to
- Study type: Interventional
- Planned participants: 145
- From 22 Nov 2019 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix
Other illness
- Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Age
- Older age (\>75 years)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| European Institute of Oncology Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.