Invasive Breast CancerfREEDOMNCT06328465
fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
A study testing Diffusion whole body MRI in people with Invasive Breast Cancer and HER2-positive Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Invasive Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Diffusion whole body MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteItaly
- Study dates
- 22 Nov 2019to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Monica Iorfida, MD, +390257489970, monica.iorfida@ieo.it
Mara Negri, +390257489536, mara.negri@ieo.it
About this study
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.
Read the detailed description
Breast cancer is the second most common cancer in the world and the most common cancer among women. In these patients, it is not the primary tumor, but its distant metastases that are the main cause of death. Follow-up may vary depending on the hospital or doctor, but the data available in the literature do not show an advantage in terms of survival or quality of life in patients subjected to intensive follow-up. However, the information that physicians have comes from past studies limited by the presence of bias regarding patient characteristics, therapies, follow-up intervals and tests used. In light of the better understanding of biology, breast cancer is no longer considered a single disease, but it is classified into at least four different molecular subtypes, based on the immunohistochemical classification: Luminal A-like, Luminal B-like, HER2 positive and Triple Negative. Nowadays it is known that not only the stage of diagnosis, but also the biology of the disease influences the risk of recurrence and death. Furthermore, a growing number of trials show that different biological subtypes differ in terms of time to relapse and disease pattern of metastatic spread (in particular, site of first relapse). These observations lead to the hypothesis that different types and different frequencies of follow-up strategies should vary depending on the biology of breast cancer. Furthermore, with improved management and the availability of new effective treatments, patients with oligometastatic disease treated with an aggressive multidisciplinary approach may be amenable to curative treatment. Based on this hypothesis, an early diagnosis of metastatic disease could lead to the identification of patients with low disease burden who can still be treated with curative intent. DWB-MRI is emerging as a promising tool for the detection and therapy monitoring of metastases in different tumor types and could be an important tool for the early detection of breast cancer metastases.
- Being tested
- Diffusion whole body MRI
- Keywords
- Invasive Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion whole body MRIDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| DWB-MRI | Experimental | Surveillance with diffusion whole body MRI Receives: Diagnostic Test: Diffusion whole body MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival
Number of alive patients at 5 years (considering deaths from any cause)
Measured: 5 years
Secondary outcomes (8)
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)
Measured: 5 years
Breast cancer specific survival
Number of alive patients at 5 years (considering only deaths related to breast cancer)
Measured: 5 years
Safety of local treatment
Number of serious adverse event related to local treatment received
Measured: 48 months
Anxiety assessment
Collection of Hamilton Anxiety Rating Scale questionnaire (minimum value: 0, maximum value: 4 - higher scores mean a worse outcome)
Measured: 48 months
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)
Measured: 48 months
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)
Measured: 48 months
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)
Measured: 48 months
Acceptability and perception of DWB-MRI
Collection of Acceptance Questionnaire (minimum value: 0, maximum value: 5 - higher scores mean a worse outcome)
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start22 Nov 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monica Iorfida, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06328465
- Sponsor's protocol ID
- UID 1743
- Other IDs
- IEO 1108
- Acronym
- fREEDOM
- Status last verified
- Jan 2026
- First submitted
- 13 Mar 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fREEDOM: REsonance for Early Detection Of Breast Cancer Metastases
- ClinicalTrials.gov ID
- NCT06328465
- Acronym / sponsor ID
- fREEDOM / UID 1743
- Keywords
- Invasive Breast Cancer, HER2-positive Breast Cancer, Triple Negative Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is the second most common cancer in the world and the most common cancer among women. In these patients, it is not the primary tumor, but its distant metastases that are the main cause of death. Follow-up may vary depending on the hospital or doctor, but the data available in the literature do not show an advantage in terms of survival or quality of life in patients subjected to intensive follow-up. However, the information that physicians have comes from past studies limited by the presence of bias regarding patient characteristics, therapies, follow-up intervals and tests used. In light of the better understanding of biology, breast cancer is no longer considered a single disease, but it is classified into at least four different molecular subtypes, based on the immunohistochemical classification: Luminal A-like, Luminal B-like, HER2 positive and Triple Negative. Nowadays it is known that not only the stage of diagnosis, but also the biology of the disease influences the risk of recurrence and death. Furthermore, a growing number of trials show that different biological subtypes differ in terms of time to relapse and disease pattern of metastatic spread (in particular, site of first relapse). These observations lead to the hypothesis that different types and different frequencies of follow-up strategies should vary depending on the biology of breast cancer. Furthermore, with improved management and the availability of new effective treatments, patients with oligometastatic disease treated with an aggressive multidisciplinary approach may be amenable to curative treatment. Based on this hypothesis, an early diagnosis of metastatic disease could lead to the identification of patients with low disease burden who can still be treated with curative intent. DWB-MRI is emerging as a promising tool for the detection and therapy monitoring of metastases in different tumor types and could be an important tool for the early detection of breast cancer metastases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DWB-MRI | Experimental | Diagnostic Test: Diffusion whole body MRISurveillance with diffusion whole body MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion whole body MRIDiffusion 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. | Diagnostic test | DWB-MRI |
Primary outcome
5-year overall survival
Time frame: 5 years
Number of alive patients at 5 years (considering deaths from any cause)
8 secondary outcomes
Overall survival of patients underwent local treatment
Time frame: 5 years
Breast cancer specific survival
Time frame: 5 years
Safety of local treatment
Time frame: 48 months
Anxiety assessment
Time frame: 48 months
Health state assessment
Time frame: 48 months
Ability to Cope With Trauma assessment
Time frame: 48 months
Personality assessment
Time frame: 48 months
Acceptability and perception of DWB-MRI
Time frame: 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Iorfida, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion whole body MRI in people with Invasive Breast Cancer and HER2-positive Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Iorfida, MD (+390257489970, monica.iorfida@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.